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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03432650
Other study ID # 2018-0647
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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