Adductor Canal Nerve Block Following Total Knee Arthroplasty

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Post-op Pain
• Intervention / Treatment: Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.; Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center East Campus Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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?

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 15ml ropivacaine; 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	Drug: Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.
Active Comparator: 30ml ropivacaine; If the subject is randomized to 30ml ropivacaine he/she will be injected through the catheter every 6 hours.	Drug: For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opiate pain medication	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	The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with pain control	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.	We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery

Collaborators and Investigators

• Sponsor: Loma Linda University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): July 25, 2017
• Study Completion (Actual): July 25, 2017

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (Estimate): September 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: nerve block; Total knee arthroplasty; Pain control after surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Ropivacaine; Morphine; Oxycodone; Analgesics; Acetaminophen, hydrocodone drug combination
• Other Study ID Numbers: 5130183

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No