Hip Disease Clinical Trial
Official title:
Evaluation of Anterior Quadratus Lumborum Block for Postoperative Analgesia in Hip Arthroscopy: A Double-Blinded Randomized Controlled Trial
Verified date | July 2022 |
Source | Hospital for Special Surgery, New York |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of Special Surgery | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Hospital for Special Surgery, New York |
United States,
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 |
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