## Protocol Section
### Identification Module
**NCT ID:** NCT01939379

**Brief Title:** Adductor Canal Nerve Block Following Total Knee Arthroplasty

**Official Title:** Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine

#### Organization Study ID Info
**ID:** 5130183
#### Organization
**Class:** OTHER
**Full Name:** Loma Linda University
### Status Module
#### Completion Date
**Date:** 2017-07-25

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-19

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2017-07-25

**Type:** ACTUAL

#### Start Date
**Date:** 2013-09

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2013-09-11
**Type:** ESTIMATED
**Study First Submit Date:** 2013-09-03
**Study First Submit QC Date:** 2013-09-05
**Why Stopped:** PI left institution. Efforts made to contact PI unsuccessful. No study data available.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Loma Linda University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.

### Conditions Module

**Conditions:**

- Post-op Pain

**Keywords:**

- Total knee arthroplasty

- nerve block

- Pain control after surgery

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Depending on what dose of ropivacaine the subject is randomized to he/she could receive the 15ml dose injected into the catheter every 6 hours

**Intervention Names:**

- Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.

**Label:** 15ml ropivacaine

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.

**Intervention Names:**

- Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.

**Label:** 30ml ropivacaine

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 15ml ropivacaine

**Name:** Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 30ml ropivacaine

**Name:** For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** At the end of the 48 hours period the total opiate pain medication taken will be collected and used for comparison as our primary outcome

**Measure:** Total Opiate pain medication

**Time Frame:** The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.

#### Secondary Outcomes

**Description:** Secondary outcome measures will include demographic characteristics, pain scores, medication administration,patient satisfaction with pain control and any complications that may have arisen. We will also record the location of the adductor canal catheter on the final bolus dose.

**Measure:** Patient satisfaction with pain control

**Time Frame:** We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Is the subject undergoing primary unilateral total knee arthroplasty?
2. Is the subject 18 to 99 years of age?
3. Is the subject ASA class 1, 2, or 3?
4. Does the subject have a BMI less than 35?
5. Can the subject consent in the English language?

Exclusion Criteria:

1. Does subject have an allergy to drugs used in this study;
2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
3. Does subject have a history of alcohol or drug abuse
4. Has subject had a previous total knee arthroplasty?
5. Has subject had any neurologic deficits in the lower extremity being studied?

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Loma Linda

**Country:** United States

**Facility:** Loma Linda University Medical Center East Campus Hospital

**State:** California

**Zip:** 92354

## 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-op 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: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- 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

- ID: D000000779

- Term: Anesthetics, Local

- ID: D000000777

- Term: Anesthetics

- ID: D000000894

- Term: Anti-Inflammatory Agents, Non-Steroidal

- ID: D000018712

- Term: Analgesics, Non-Narcotic

- ID: D000000893

- Term: Anti-Inflammatory Agents

- ID: D000018501

- Term: Antirheumatic Agents

- ID: D000058633

- Term: Antipyretics

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Analg

- Name: Analgesics

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Antipy

- Name: Antipyretics

- Abbrev: AnTuAg

- Name: Antitussive Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M1700

- Name: Ropivacaine

- Relevance: HIGH

- As Found: Eye

- ID: M11982

- Name: Morphine

- Relevance: HIGH

- As Found: 400

- ID: M4032

- Name: Analgesics

- Relevance: HIGH

- As Found: Pregnancy Loss

- ID: M225501

- Name: Acetaminophen, hydrocodone drug combination

- Relevance: HIGH

- As Found: Flight

- ID: M2340

- Name: Acetaminophen

- Relevance: HIGH

- As Found: Flight

- ID: M9911

- Name: Hydrocodone

- Relevance: LOW

- As Found: Unknown

- ID: M13020

- Name: Oxycodone

- Relevance: HIGH

- As Found: Flight

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: LOW

- As Found: Unknown

- ID: M4217

- Name: Anti-Inflammatory Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4218

- Name: Anti-Inflammatory Agents, Non-Steroidal

- Relevance: LOW

- As Found: Unknown

- ID: M20786

- Name: Analgesics, Non-Narcotic

- Relevance: LOW

- As Found: Unknown

- ID: M20604

- Name: Antirheumatic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M29176

- Name: Antipyretics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000082

- Term: Acetaminophen

- ID: C000083640

- Term: Acetaminophen, hydrocodone drug combination

- ID: D000009020

- Term: Morphine

- ID: D000010098

- Term: Oxycodone

- ID: D000000700

- Term: Analgesics

- ID: D000077212

- Term: Ropivacaine

### Misc Info Module

- Version Holder: 2024-05-24
