Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy

NCT03432650 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 2018-0647
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Disease

Outcome Measures

Primary Outcomes (5)

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  30min after Post Anesthesia Care Unite (PACU) arrival

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  1 hour after Post Anesthesia Care Unite (PACU) arrival

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  2 hours after Post Anesthesia Care Unite (PACU) arrival

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  3 hours after Post Anesthesia Care Unite (PACU) arrival

• Numerical Pain Rating System (NRS) Pain Scores

  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.

  24 hours after Post Anesthesia Care Unite (PACU) arrival

Secondary Outcomes (10)

• Opioid Use

  After Surgery to Post Operative Day 1

• Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery

  Immediately post-op in OR

• Number of Patients With Nausea/Vomiting

  Up to Post Op Day 1

• Antiemetic Use

  Up to Post Op Day 1

• Number of Participants With Hospital Admission

  Up to Post Op Day 1

Study Arms (2)

QLB Block + Standard of Care

EXPERIMENTAL

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).

Drug: Bupivacaine + dexamethasone; Device: Ultrasound

Standard of Care

NO INTERVENTION

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.

Interventions

Bupivacaine + dexamethasone DRUG

Anesthetic that will help treat pain and sensation after hip arthroscopy

QLB Block + Standard of Care

Ultrasound DEVICE

Ultrasound will help guide the anesthesiologist in performing the nerve block

QLB Block + Standard of Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital of Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Interventions

Bupivacaine; Dexamethasone; Ultrasonography

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Stephen Haskins
• Organization: Hospital for Special Surgery, Anesthesiology

haskinss@hss.edu

212-606-1036

Study Officials

• Stephen Haskins, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 14, 2018
• Study Start: June 1, 2018
• Primary Completion: December 20, 2020
• Study Completion: September 9, 2021
• Last Updated: August 19, 2022
• Results First Posted: August 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)