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

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

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.

Study Overview

• Status: Completed
• Conditions: Hip Disease
• Intervention / Treatment: Drug: Bupivacaine + dexamethasone; Device: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital of Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Drug: Bupivacaine + dexamethasone; Anesthetic that will help treat pain and sensation after hip arthroscopy; Device: Ultrasound; Ultrasound will help guide the anesthesiologist in performing the nerve block
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Use	Amount of opioids taken after surgery	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
Patient Satisfaction With Post Op Pain Control	Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied	Up to Post Op Day 1
Patient Score on Quality of Recovery-40 (QoR40) Inventory.	Validated QoR40 survey score. Survey questions are added up to provide a final score. Higher score is reflective of a better outcome. Minimum score is 40, maximum score is 200.	Up to Post Op Day 1
Change in Quadriceps Motor Strength on Surgical Side	Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength	Up to Post Op Day 1
Urinary Retention	Incidence of Urinary Retention in recovery	Up to Post Op Day 1
Incidence of Hypotension		Up to Post Op Day 1

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Stephen Haskins, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): September 9, 2021

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: 2018-0647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No