## Protocol Section
### Identification Module
**NCT ID:** NCT03187379

**Brief Title:** Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

**Official Title:** Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

#### Organization Study ID Info
**ID:** 16-1571
#### Organization
**Class:** OTHER
**Full Name:** The Cleveland Clinic
### Status Module
#### Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-06-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-01-26

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-06-21

**Type:** ACTUAL

**Results First Submit Date:** 2022-04-27

**Results First Submit QC Date:** 2022-06-16

#### Start Date
**Date:** 2017-06-01

**Type:** ACTUAL

**Status Verified Date:** 2022-06

#### Study First Post Date
**Date:** 2017-06-14
**Type:** ACTUAL
**Study First Submit Date:** 2017-06-01
**Study First Submit QC Date:** 2017-06-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Matthew Kroh

#### Responsible Party

**Investigator Affiliation:** The Cleveland Clinic

**Investigator Full Name:** Matthew Kroh

**Investigator Title:** Principal investigator

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.

**Detailed Description:** The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.

### Conditions Module

**Conditions:**

- Post-operative Pain Management

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 102

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

**Intervention Names:**

- Drug: Exparel

**Label:** Exparel, Liposomal Bupivacaine

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

**Intervention Names:**

- Drug: Bupivacaine

**Label:** Control

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Exparel, Liposomal Bupivacaine

**Description:** Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine

**Name:** Exparel

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control

**Description:** 60cc Bupivacaine

**Name:** Bupivacaine

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.

**Measure:** Post-Operative Pain

**Time Frame:** 24 hours post-surgery

#### Secondary Outcomes

**Description:** Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.

**Measure:** Post-Operative Pain

**Time Frame:** 48 hours post-surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* bariatric surgery patients
* laparoscopic roux-en-y gastric bypass
* use of EEA stapler anastomosis

Exclusion Criteria:

* age \<18 years
* previous history of roux-en-y gastric bypass
* patients undergoing other bariatric procedures
* pre-operative opioid analgesics

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic

**State:** Ohio

**Zip:** 44195

#### Overall Officials

**Official 1:**

**Affiliation:** Staff

**Name:** Alisan Fathalizadeh, M.D

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2020-03-23

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 1496210

- Type Abbrev: Prot_SAP

- Upload Date: 2022-02-17T15:56

- Date: 2020-04-15

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 272624

- Type Abbrev: ICF

- Upload Date: 2022-02-17T16:03

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M5315

- Name: Bupivacaine

- Relevance: HIGH

- As Found: Following

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000002045

- Term: Bupivacaine

### Misc Info Module

#### Submission Tracking

##### First MCP Info

###### Post Date

- Date: 2022-05-17

- Type: ACTUAL

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Exparel, Liposomal Bupivacaine

**Deaths Num At Risk:** 50

**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine

**ID:** EG000

**Other Num Affected:** 14

**Other Num at Risk:** 50

**Serious Number Affected:** 10

**Serious Number At Risk:** 50

**Title:** Exparel, Liposomal Bupivacaine

**Group ID:** EG001

**Title:** Control

**Deaths Num At Risk:** 52

**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

Bupivacaine: 60cc Bupivacaine

**ID:** EG001

**Other Num Affected:** 27

**Other Num at Risk:** 52

**Serious Number Affected:** 15

**Serious Number At Risk:** 52

**Title:** Control

**Frequency Threshold:** 0

#### Other Events

**Term:** Bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** 

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Pain- Not otherwise Specified

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Cellulitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Wound Drainage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** 

**Term:** Shortness of Breath

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Pelvic Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Knee Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Vaginal Bleed

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** 

**Term:** Leg Burn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Left Ankle Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Foot Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** 

**Term:** Back Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Abnormal labs

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** 

**Term:** Black Stool

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Left Side Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Swollen Leg

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Right Eye Complaint

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Infection- Not otherwise Specified

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Hip Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** 

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 50

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 52

**Num Events:** 3

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 50

**Num Events:** 3

**Group ID:** EG001

**Num Affected:** 4

**Num At Risk:** 52

**Num Events:** 4

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Small Bowel Obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 52

**Term:** Abdominal Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 50

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 5

**Num At Risk:** 52

**Num Events:** 5

**Term:** Bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 52

**Term:** Ileus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 2

**Num At Risk:** 52

**Num Events:** 2

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 52

**Term:** Left Side Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Right Flank Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Chills

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Abdominal Abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Wound Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Term:** Post Operative Complications

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 50

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 52

**Term:** Shortness of Breath

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 50

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 52

**Num Events:** 1

**Time Frame:** 1 year

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 52

**Group ID:** BG002

**Value:** 102

**Units:** Participants

### Group

**ID:** BG000

**Title:** Exparel, Liposomal Bupivacaine

**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine

### Group

**ID:** BG001

**Title:** Control

**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

Bupivacaine: 60cc Bupivacaine

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 37.1

**Upper Limit:** 56.2

**Value:** 48.4

#### Measurement

**Group ID:** BG001

**Lower Limit:** 36.3

**Upper Limit:** 52.2

**Value:** 41.2

#### Measurement

**Group ID:** BG002

**Lower Limit:** 36.7

**Upper Limit:** 55.3

**Value:** 44.6

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 52

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 40

#### Measurement

**Group ID:** BG001

**Value:** 42

#### Measurement

**Group ID:** BG002

**Value:** 82

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 10

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 20

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 52

**Group ID:** BG002

**Value:** 102

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Group ID:** BG001

**Value:** 0

**Group ID:** BG002

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 50

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 102

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 50

**Group ID:** BG001

**Value:** 52

**Group ID:** BG002

**Value:** 102

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** Years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** krohm@ccf.org
**Organization:** Cleveland Clinic Foundation
**Phone:** 12164457410
**Title:** Dr. Matthew Kroh
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 29
- **Upper Limit:** 
- **Value:** 49.4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 26.4
- **Upper Limit:** 
- **Value:** 56.6
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 30
- **Upper Limit:** 
- **Value:** 42.2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 31.4
- **Upper Limit:** 
- **Value:** 51.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 24 hours post-surgery
**Title:** Post-Operative Pain
**Type:** PRIMARY
**Unit of Measure:** units on a Visual Analog Scale (VAS)
##### Group
**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
**ID:** OG000
**Title:** Exparel, Liposomal Bupivacaine
##### Group
**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

Bupivacaine: 60cc Bupivacaine
**ID:** OG001
**Title:** Control
#### Outcome Measure 2
**Description:** Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 48 hours post-surgery
**Title:** Post-Operative Pain
**Type:** SECONDARY
**Unit of Measure:** units on a Visual Analog Scale (VAS)
##### Group
**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
**ID:** OG000
**Title:** Exparel, Liposomal Bupivacaine
##### Group
**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

Bupivacaine: 60cc Bupivacaine
**ID:** OG001
**Title:** Control
### Participant Flow Module
#### Group
**Description:** Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing

Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
**ID:** FG000
**Title:** Exparel, Liposomal Bupivacaine
#### Group
**Description:** Subjects in this arm will receive 0.25% bupivacaine alone

Bupivacaine: 60cc Bupivacaine
**ID:** FG001
**Title:** Control
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 52
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 50
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 52
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True