US Guided GNB vs Saline Injection for TKA

NCT03316118 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: STU#:00204116
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Do ultrasound-guided genicular nerve blocks with 0.5% bupivacaine provide improved knee analgesia for patients recovering from total knee replacement surgery compared to saline injection? Hypotheses: The investigators hypothesize that the combination of ultrasound-guided adductor canal block (ACB) and genicular nerve block will achieve lower opioid consumption and therefore lead to decreased systemic side effects and improved overall satisfaction compared to ultrasound-guided saline injection for patients undergoing minimally invasive elective total knee arthroplasty (TKA).

Conditions

Postoperative Pain; Total Knee Arthroplasty; Nerve Block

Keywords

anesthesiology; pain; arthroplasty

Outcome Measures

Primary Outcomes (1)

• Post-operative Opioid Consumption During the Hospital Stay

  Post-operative opioid consumption measured in morphine milligram equivalents (MME)during the hospital stay up to 36 hours after surgery.

  36 hours after surgery

Secondary Outcomes (3)

• Mean Pain Scores of the Knee at Rest for the First 48 Hours After Surgery

  48 hours after surgery

• Overall Satisfaction With Pain Control 72 Hours After Surgery

  72 hours after surgery

• Length of Hospitalization

  Admission to discharge from hospital

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Patient will receive genicular nerve block with bupivacaine

Drug: bupivacaine

Group 2

PLACEBO COMPARATOR

Patient will receive normal saline as the nerve block

Drug: saline

Interventions

bupivacaine DRUG

Group 1 will receive genicular nerve block using bupivacaine

Also known as: BUPIV

Group 1

saline DRUG

Group 2 will receive genicular nerve block using normal saline

Also known as: SAL

Group 2

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants 40 to 85 years old who are presenting for minimally invasive total knee arthroplasty under spinal anesthesia and are candidates for peripheral nerve blocks.
• Minimally invasive is defined as custom modified instrumentation, a quadriceps sparing arthrotomy that does not extend beyond 1cm proximal to the patella and surgical techniques that focus on soft tissue protection.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The limitation to the results is that the study was terminated early for low enrollment.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312 695 1064

Study Officials

• Antoun M Nader, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 20, 2017
• Study Start: October 5, 2017
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)