Skip to main content
Clinical Trials/NCT03432650
NCT03432650
Completed
Phase 3

Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial

Hospital for Special Surgery, New York1 site in 1 country96 target enrollmentJune 1, 2018

Overview

Phase
Phase 3
Intervention
Bupivacaine + dexamethasone
Conditions
Hip Disease
Sponsor
Hospital for Special Surgery, New York
Enrollment
96
Locations
1
Primary Endpoint
Numerical Pain Rating System (NRS) Pain Scores
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Hip arthroscopy is performed frequently and the postoperative course often involves moderate to severe pain. There remains no definitive perioperative pain regimen that has been proven to be effective and safe for this ambulatory procedure. Some institutions perform peripheral nerve blocks either preoperatively or postoperatively as a rescue block. All of these PNBs lead to quadriceps weakness which may impede earlier mobilization and physical therapy. While some case reports exist, there have not been any studies evaluating the QLB for hip arthroscopy patients. As previously mentioned, the technique is easy to perform, well-tolerated by patients, and avoids side effects such as hypotension, urinary retention, or the quadriceps weakness associated with lumbar plexus blockade.

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
September 9, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital for Special Surgery, New York
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for hip arthroscopy
  • Ability to follow study protocol
  • English Speaking

Exclusion Criteria

  • Hepatic or renal insufficiency
  • Younger than 18 years old and older than 80
  • Allergy or intolerance to one of the study medications
  • Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  • Chronic opioid use (daily opioids use for longer than 3 months)
  • Patients contraindicated to undergo a spinal anesthetic
  • Non English Speakers

Arms & Interventions

QLB Block + Standard of Care

Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given. Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).

Intervention: Bupivacaine + dexamethasone

QLB Block + Standard of Care

Patients will receive either a spinal (4cc Mepivacaine) or combined spinal epidural anesthetic (dose up 50 5 cc 2% lidocaine) with IV sedation. Intraoperative anti-emetics will consist of IV ondansetron and IV dexamethasone. Intra-operative analgesics will be IV fentanyl, IV acetaminophen, IV ketorolac, and IV ketamine. No Block will be given. Patients will receive a single shot anterior QLB (30cc 0.5% Bupivacaine with 2mg preservative free dexamethasone).

Intervention: Ultrasound

Outcomes

Primary Outcomes

Numerical Pain Rating System (NRS) Pain Scores

Time Frame: 24 hours after Post Anesthesia Care Unite (PACU) arrival

Pain scores at rest and with movement will be through 24 hours after surgery. Score scale is from 0-10. 0 means no pain, 10 means worst pain. A lower score is a better outcome.

Secondary Outcomes

  • Urinary Retention(Up to Post Op Day 1)
  • Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery(Immediately post-op in OR)
  • Incidence of Hypotension(Up to Post Op Day 1)
  • Opioid Use(After Surgery to Post Operative Day 1)
  • Antiemetic Use(Up to Post Op Day 1)
  • Patient Satisfaction With Post Op Pain Control(Up to Post Op Day 1)
  • Change in Quadriceps Motor Strength on Surgical Side(Up to Post Op Day 1)
  • Number of Participants With Hospital Admission(Up to Post Op Day 1)
  • Number of Patients With Nausea/Vomiting(Up to Post Op Day 1)
  • Patient Score on Quality of Recovery-40 (QoR40) Inventory.(Up to Post Op Day 1)

Study Sites (1)

Loading locations...

Similar Trials