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Completed

NCT Number: NCT03432650

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

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital of Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine + Dexamethasone

Drug

Anesthetic that will help treat pain and sensation after hip arthroscopy

Ultrasound

Device

Ultrasound will help guide the anesthesiologist in performing the nerve block

Primary outcomes

  1. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 30min after Post Anesthesia Care Unite (PACU) arrival

    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. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 1 hour after Post Anesthesia Care Unite (PACU) arrival

    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. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 2 hours after Post Anesthesia Care Unite (PACU) arrival

    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.

  4. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 3 hours after Post Anesthesia Care Unite (PACU) arrival

    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.

  5. Numerical Pain Rating System (NRS) Pain Scores

    Time frame: 24 hours after Post Anesthesia Care Unite (PACU) arrival

    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.

Secondary outcomes

  1. Opioid Use

    Time frame: After Surgery to Post Operative Day 1

    Amount of opioids taken after surgery

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

    Time frame: Immediately post-op in OR

  3. Number of Patients With Nausea/Vomiting

    Time frame: Up to Post Op Day 1

  4. Antiemetic Use

    Time frame: Up to Post Op Day 1

  5. Number of Participants With Hospital Admission

    Time frame: Up to Post Op Day 1

  6. Patient Satisfaction With Post Op Pain Control

    Time frame: Up to Post Op Day 1

    Scale of 0-10; 0 being extremely dissatisfied and 10 being extremely satisfied

  7. Patient Score on Quality of Recovery-40 (QoR40) Inventory.

    Time frame: Up to Post Op Day 1

    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.

  8. Change in Quadriceps Motor Strength on Surgical Side

    Time frame: Up to Post Op Day 1

    Change in Quadriceps Motor Strength from Pre-Op Baseline Quadriceps Strength

  9. Urinary Retention

    Time frame: Up to Post Op Day 1

    Incidence of Urinary Retention in recovery

  10. Incidence of Hypotension

    Time frame: Up to Post Op Day 1

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Feb 14, 2018
Registry last updated
Aug 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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