A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement

Sponsor
Northwestern University (Other)
Overall Status
Terminated
CT.gov ID
NCT03316118
Collaborator
(none)
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Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
A Comparison of Analgesic Efficacy of Ultrasound-Guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
Actual Study Start Date :
Oct 5, 2017
Actual Primary Completion Date :
Jun 21, 2021
Actual Study Completion Date :
Jun 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1

Patient will receive genicular nerve block with bupivacaine

Drug: bupivacaine
Group 1 will receive genicular nerve block using bupivacaine

Placebo Comparator: Group 2

Patient will receive normal saline as the nerve block

Drug: saline
Group 2 will receive genicular nerve block using normal saline

Outcome Measures

Primary Outcome Measures

  1. Post-operative opioid consumption during the hospital stay [21 days after surgery]

    Post-operative opioid consumption measured in morphine equivalents during the hospital stay.

Secondary Outcome Measures

  1. Pain scores in the knee at rest and during activity recorded every 6 hours up to discharge [21 days after surgery]

    Pain scores in the knee at rest and during activity. This will be measured every 6 hours up to discharge with the visual analog scale where 0 equals no pain and 10 equals excruciating pain. Low pain scores are considered a better outcome than high pain scores.

  2. Overall global pain score recorded every 6 hours up to discharge [21 days after surgery]

    Overall global pain score. This will be measured every 6 hours up to discharge with the visual analog scale where 0 equals no pain and 10 equals excruciating pain. Low pain scores are considered a better outcome than high pain scores.

  3. Overall pain burden for the first 36 hours [36 hours after surgery]

    Pain burden is defined as the area under the visual analog scale for pain over the first 36 hours and will be calculated using the trapezoidal method. Time to report first pain and overall patient satisfaction between groups will be compared using the Kruskal-Wallis H test.

  4. Opioid related side effects [21 days after surgery]

  5. Time to physical therapy milestones [21 days after surgery]

    active straight leg raise, time until patient first gets out of bed, ambulation about the hospital room with or without assistance, ambulating 100 feet and ability to climb stairs

  6. Length of hospitalization [21 days after surgery]

  7. Readmission to the hospital or emergency room visit for evaluation during study [1 year after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Antoun M Nader, MD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antoun Nader, Principle Investigator, Northwestern University
ClinicalTrials.gov Identifier:
NCT03316118
Other Study ID Numbers:
  • STU#:00204116
First Posted:
Oct 20, 2017
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Antoun Nader, Principle Investigator, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021