Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty

NCT03133481 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: F140917004
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral nerve blocks catheters of the femoral nerve have long been used for perioperative analgesia in total knee arthroplasty (TKA). These blocks provide effective analgesia and patient satisfaction for surgical pain relief. However, one of the main drawbacks to the femoral nerve block (FNB) is a denser motor block of the quadriceps muscle that can delay aggressive physical therapy and subsequent recovery from surgery. (1) Recently, there has been increasing interest in performing adductor canal blocks (ACB) with the aim of less motor blockade while providing commensurate analgesia compared to the FNB. (1,2) Current investigative reports have provided only preliminary data, and there is potential to change the standard of care for TKA as more data mounts in favor of ACBs. The goal of this study is to verify the analgesic equivalence of the two blocks, compare patient satisfaction, surgeon satisfaction, and physical therapy grading between the two blocks. Potentially, this would change the standard of care for TKA patients at this institution.

Conditions

Arthropathy of Knee

Keywords

Adductor Canal Block; Femoral Canal Block

Outcome Measures

Primary Outcomes (2)

• Mean Distance Ambulated at 24 Hours Post Operatively

  Distance ambulated in feet from the end of surgery to 24 hours postoperatively

  Baseline up to 24 hours after the Anesthesia Record Stop Time

• Mean Distance Ambulated at 48 Hours Post Operatively

  Distance ambulated in feet from the end of surgery to 48 hours postoperatively

  From the Anesthesia Record Stop Time to 48 hours after the Anesthesia Record Stop Time

Secondary Outcomes (10)

• Mean Pain Scores Immediately Preoperatively

  baseline up to time of anesthesia record start time

• Mean Opioid Consumption as Measured by Oral Morphine Milligram Equivalents

  from baseline to two hours

• Patient Satisfaction at 48 Hours Post Operatively

  Baseline up to 48 hrs

• Mean Hours to Discharge

  Baseline to discharge (approximately 90 hrs)

• Mean Pain Scores in PACU

  Immediately post operatively, not more than 4 hours after pacu admittance

Study Arms (2)

Adductor Canal Nerve Block

ACTIVE COMPARATOR

Participants will be randomized using block randomization.

Procedure: Adductor Canal Nerve Block

Femoral Nerve Block

ACTIVE COMPARATOR

Participants will be randomized using block randomization.

Drug: Femoral Nerve Block

Interventions

Adductor Canal Nerve Block PROCEDURE

Adductor Canal never technique

Also known as: ropivacaine

Adductor Canal Nerve Block

Femoral Nerve Block DRUG

Traditional technique

Also known as: ropivacaine

Femoral Nerve Block

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient undergoing total knee arthroplasty with regional anesthesia planned for postoperative analgesia.
• Adult, 19 years of age or older
• Patient classified as American Society of Anesthesiology (ASA) class I, II, or III

You may not qualify if:

• Any subject not classified as an ASA I, II, or III
• Allergy/intolerance to local anesthetic
• Pre-existing neurologic or anatomic deficit in lower extremity on the side of the surgical site
• Coexisting coagulopathy such as hemophilia or von Willebrand disease

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Adam Sturdivant
• Organization: University of Alabama at Birmingham

Adamsturdivant@uabmc.edu

205-934-4042

Study Officials

• Promil Kukreja, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first two groups will have 50 participants each (100 total) the "Adductor Canal Nerve Catheter" group and the "Femoral Nerve Catheter," group. Participants will be randomized using block randomization. The blocks will be assigned randomly based on computer generated numbers.

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 28, 2017
• Study Start: October 22, 2014
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2019
• Last Updated: January 16, 2019
• Results First Posted: January 16, 2019

Record last verified: 2019-01

Locations

US (1)