## Protocol Section
### Identification Module
**NCT ID:** NCT02100579

**Brief Title:** Ultrasound-guided Adductor Canal Block for Total Knee Replacement

**Official Title:** Ultrasound-guided Adductor Canal Block for Total Knee Replacement: a Randomized, Double-blind Placebo Controlled Trial.

#### Organization Study ID Info
**ID:** STU00088239
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
#### Secondary ID Infos
**Domain:** Northwestern University IRB
**ID:** STU00088239
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2015-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-07-11

**Type:** ACTUAL

**Last Update Submit Date:** 2017-06-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-11-02

**Type:** ESTIMATED

**Results First Submit Date:** 2016-09-14

**Results First Submit QC Date:** 2016-09-14

#### Start Date
**Date:** 2014-03

**Status Verified Date:** 2017-06

#### Study First Post Date
**Date:** 2014-04-01
**Type:** ESTIMATED
**Study First Submit Date:** 2014-03-25
**Study First Submit QC Date:** 2014-03-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Antoun Nader

**Investigator Title:** Professor of Anesthesiology

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Total knee arthroplasty is associated with intense early postoperative pain. Fast track recovery programs including early therapy protocols and early hospital discharge are being implemented at various hospitals. The postoperative analgesic pain regimen should enhance functional recovery in addition to providing efficient analgesia with minimal side effects. Adductor canal blockade is commonly used to provide postoperative analgesia for total knee arthroplasty (TKA) surgery. The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

**Detailed Description:** The investigators hypothesize that an ultrasound guided adductor canal block will lower narcotic consumption and improved overall satisfaction compared to ultrasound guided sham block with normal saline (placebo) for patients undergoing minimally invasive TKA surgery.

### Conditions Module

**Conditions:**

- Complications; Arthroplasty

- Knee Injuries

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

**Intervention Names:**

- Drug: Bupivacaine

**Label:** Active Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

**Intervention Names:**

- Drug: Preservative free normal saline

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active Group

**Description:** 10 ml of 0.25% bupivacaine

**Name:** Bupivacaine

**Other Names:**

- Sensorcaine

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** 10 ml of preservative free normal saline

**Name:** Preservative free normal saline

**Other Names:**

- 0.9% sodium chloride

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Opioid consumption (morphine equivalents)

**Measure:** Opioid Consumption (mg morEq)

**Time Frame:** 36 hours

#### Secondary Outcomes

**Description:** Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.

**Measure:** Visual Analog Scale Pain Score

**Time Frame:** Pain burden at 36hr

**Description:** The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.

**Measure:** Length of Hospitalization

**Time Frame:** 0 to 192 hours

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Participants 40 to 75 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia

Exclusion Criteria:

* Patient refusal
* American Society of Anesthesiologists physical status classification of 4 or higher
* Pre-existing neuropathy in the femoral or sciatic distribution
* Coagulopathy
* Infection at the site
* Chronic opioid use (greater than 3 months)
* Pregnancy
* Medical conditions limiting physical therapy participation
* Any other contra-indication to regional anesthesia

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chicago

**Country:** United States

**Facility:** Northwestern University Feinberg School of Medicine

**State:** Illinois

**Zip:** 60611

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University Feinberg School of Medicine

**Name:** Antoun Nader, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007869

- Term: Leg Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M10738

- Name: Knee Injuries

- Relevance: HIGH

- As Found: Knee Injuries

- ID: M10881

- Name: Leg Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007718

- Term: Knee Injuries

### 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

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Active Group

**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine

**ID:** EG000

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Active Group

**Group ID:** EG001

**Title:** Control Group

**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline

**ID:** EG001

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Control Group

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Group ID:** BG001

**Value:** 20

**Group ID:** BG002

**Value:** 40

**Units:** Participants

### Group

**ID:** BG000

**Title:** Active Group

**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine

### Group

**ID:** BG001

**Title:** Control Group

**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 8

#### Measurement

**Group ID:** BG001

**Value:** 9

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 12

#### Measurement

**Group ID:** BG001

**Value:** 11

#### Measurement

**Group ID:** BG002

**Value:** 23

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 62

**Upper Limit:** 73

**Value:** 68

#### Measurement

**Group ID:** BG001

**Lower Limit:** 59

**Upper Limit:** 72

**Value:** 67

#### Measurement

**Group ID:** BG002

**Lower Limit:** 62

**Upper Limit:** 72

**Value:** 67

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 13

#### Measurement

**Group ID:** BG002

**Value:** 28

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 5

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** INTER_QUARTILE_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** a-nader2@northwestern.edu
**Organization:** Northwestern University, Feinberg School of Medicine
**Phone:** 312-695-3045
**Title:** Antoun Nader
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 39
- **Spread:** 
- **Upper Limit:** 61
- **Value:** 48
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 49
- **Spread:** 
- **Upper Limit:** 85
- **Value:** 60
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 37
- **Spread:** 
- **Upper Limit:** 120
- **Value:** 71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 92
- **Spread:** 
- **Upper Limit:** 161
- **Value:** 131
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 64
- **Spread:** 
- **Upper Limit:** 83
- **Value:** 73
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 76
- **Spread:** 
- **Upper Limit:** 111
- **Value:** 92
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Opioid consumption (morphine equivalents)
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 36 hours
**Title:** Opioid Consumption (mg morEq)
**Type:** PRIMARY
**Unit of Measure:** Morphine Equivalents
##### Group
**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine
**ID:** OG000
**Title:** Active Group
##### Group
**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 2
**Description:** Visual Analog Scale pain score; 0 = no pain, 10 = excruciating pain) in the knee recorded every 6 hours up to 36hrs following surgery.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** Pain burden at 36hr
**Title:** Visual Analog Scale Pain Score
**Type:** SECONDARY
**Unit of Measure:** scores*hours
##### Group
**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine
**ID:** OG000
**Title:** Active Group
##### Group
**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline
**ID:** OG001
**Title:** Control Group
#### Outcome Measure 3
**Description:** The average time to discharge in hours. Participants were discharged home went physical therapy criteria were met.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** 0 to 192 hours
**Title:** Length of Hospitalization
**Type:** SECONDARY
**Unit of Measure:** hours
##### Group
**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine
**ID:** OG000
**Title:** Active Group
##### Group
**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline
**ID:** OG001
**Title:** Control Group
### Participant Flow Module
#### Group
**Description:** Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine

Bupivacaine: 10 ml of 0.25% bupivacaine
**ID:** FG000
**Title:** Active Group
#### Group
**Description:** Ultrasound-guided sham block with 10 ml of preservative free normal saline

Preservative free normal saline: 10 ml of preservative free normal saline
**ID:** FG001
**Title:** Control Group
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
**Has Results:** True