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

Hip Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432650
• Other study ID #: 2018-0647
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2018
• Est. completion date: September 9, 2021

Study information

• Verified date: July 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 9, 2021
• Est. primary completion date: December 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Disease

Intervention

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

Locations

Country	Name	City	State
United States	Hospital of Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Opioid Use	Amount of opioids taken after surgery	After Surgery to Post Operative Day 1
Secondary	Number of Patients With Presence of IAFE (Intraabdominal Fluid Extravasation) Following Surgery		Immediately post-op in OR
Secondary	Number of Patients With Nausea/Vomiting		Up to Post Op Day 1
Secondary	Antiemetic Use		Up to Post Op Day 1
Secondary	Number of Participants With Hospital Admission		Up to Post Op Day 1
Secondary	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
Secondary	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
Secondary	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
Secondary	Urinary Retention	Incidence of Urinary Retention in recovery	Up to Post Op Day 1
Secondary	Incidence of Hypotension		Up to Post Op Day 1