Clinical trial NCT03506620: The Role of Nerve Blocks in Hip Arthroscopy
Official title: The Role of Nerve Blocks in Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Femoroacetabular Impingement
Keywords: femoroacetabular impingement
hip arthroscopy
QL nerve block
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine whether QL blocks reduce opioid consumption following arthroscopic hip surgery by decreasing postoperative pain. Considering the current opioid epidemic, the responsibility of physicians to help prevent addiction, and the increasing prevalence of arthroscopic hip surgeries, this study holds a tremendous potential benefit for future patients.

Detailed description: The popularity of arthroscopic hip surgery has increased greatly over the last 10 years, particularly for correcting Femoroacetabular Impingement (FAI). FAI is a structural abnormality of the proximal femur, the acetabulum, or both. It is a leading cause of labral tears in the hip joint and can cause cartilage damage, which may increase subsequent risk of developing osteoarthritis. Though far less invasive than open hip surgery such as for a total hip replacement, hip arthroscopy can cause significant postoperative pain for the patient. Given how relatively new the procedure still is, methods of pain control are highly variable. Peripheral nerve blocks, mainly femoral nerve and lumbar plexus blocks, have been used by some surgeons to control postoperative pain. However, in addition to their sensory effects, these blocks cause motor impairment that has been associated with a significantly higher risk of falling.

In managing pain after any operation, opioid consumption is, of course, a significant concern. Ideally, hip arthroscopy patients could receive a peripheral nerve block that decreases pain and the need for opioids, but without the muscular weakness and increased fall risk observed with femoral nerve and lumbar plexus blocks. This may be achievable with the newer Quadratus Lumborum (QL) block.

The ultrasound-guided QL block is currently most commonly used for abdominal surgery.

However, several case studies of a single-injection QL block in hip replacement surgeries have been successful in minimizing pain and opioid use while sparing motor function and avoiding the muscle weakness that can lead to falls. In the approach utilized in these cases, local anesthetic was injected at the anterolateral border of the QL muscle to achieve analgesia ranging from the T6-T10 through L3 dermatomes. One group has anecdotally reported great success in using these QL blocks for alleviating postoperative pain with hip arthroscopy, but no studies to date have evaluated the effectiveness of QL blocks for arthroscopic hip surgery.

This study is a randomized, controlled, double-blind trial. Patients undergoing hip arthroscopy who agree to participate will be randomly selected to receive an ultrasound-guided QL block with either local anesthetic (QL block group) or normal saline (control group) preoperatively.

After surgery and during the first postoperative week, patients will record their numerical pain score, the location of their pain, and their opioid consumption using our attached study instrument. On this form, they will record their pain score at 0.5, 1, 1.5, 2, 4, 6, 12, 24, and 48 hours and 7 days after surgery. The form specifies that if patients are unable to record their pain score at any of these time points, particularly because they are sleeping/recovering, they can simply skip that time point. For pain location, patients are instructed to draw X's on a standard cartoon at the site of their pain. For opioid consumption, patients simply record when and how many pills they take. This form will be collected from patients at their 10-14 day postoperative visit. Data will also be collected from the medical chart on time to discharge and any complications in the perioperative period. Questionnaires will be used to assess pain, physical and social health, such as Patient-Reported Outcomes Measurement Information System (PROMIS).

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to receive unilateral arthroscopy hip surgery at Columbia University Medical Center with Dr. Lynch.

Exclusion Criteria:

* Patients scheduled to receive bilaterally or staged hip arthroscopy.
* Patients unwilling to participate in the research.
* History of chronic opioid use.
* Contraindication or allergy to study medications, such as QL block.

Primary outcomes:
measure: Pain Score
timeFrame: 0.5 hour
measure: Pain Score
timeFrame: 1 hour
measure: Pain Score
timeFrame: 1.5 hours
measure: Pain Score
timeFrame: 2 hours
measure: Pain Score
timeFrame: 4 hours
measure: Pain Score
timeFrame: 6 hours
measure: Pain Score
timeFrame: 12 hours
measure: Pain Score
timeFrame: 24 hours
measure: Pain Score
timeFrame: 48 hours
measure: Pain Score
timeFrame: 7 days
measure: Oral Morphine Equivalents
timeFrame: 24 hours after surgery
measure: Oral Morphine Equivalents
timeFrame: 48 hours after surgery
measure: Oral Morphine Equivalents
timeFrame: 7 days after surgery
measure: Patient Satisfaction Score
timeFrame: 24 hours after surgery
measure: Patient Satisfaction Score
timeFrame: 48 hours after surgery
measure: Patient Satisfaction Score
timeFrame: 7 days after surgery
measure: Percentage of Patients Reporting Nausea and/or Vomiting
timeFrame: 24 hours after surgery
measure: Percentage of Patients Reporting Nausea and/or Vomiting
timeFrame: 48 hours after surgery
measure: Percentage of Patients Reporting Nausea and/or Vomiting
timeFrame: 7 days after surgery
Secondary outcomes:
measure: HOS-ADL Questionnaire Score
timeFrame: Baseline preoperative
measure: HOS-ADL Questionnaire Score
timeFrame: 2 weeks after surgery
measure: mHHS Questionnaire Score
timeFrame: Baseline preoperative
measure: mHHS Questionnaire Score
timeFrame: 2 weeks after surgery
measure: HOOS - Symptoms and Stiffness Questionnaire Score
timeFrame: Baseline preoperatively
measure: HOOS - Symptoms and Stiffness Questionnaire Score
timeFrame: 2 weeks after surgery
measure: HOOS - ADL Questionnaire Score
timeFrame: Baseline preoperatively
measure: HOOS - ADL Questionnaire Score
timeFrame: 2 weeks after surgery
measure: HOOS - Sports Questionnaire Score
timeFrame: Baseline preoperatively
measure: HOOS - Sports Questionnaire Score
timeFrame: 2 weeks after surgery
measure: HOOS - Quality of Life Questionnaire Score
timeFrame: Baseline preoperatively
measure: HOOS - Quality of Life Questionnaire Score
timeFrame: 2 weeks after surgery
measure: UCLA Activity Score Questionnaire Score
timeFrame: Baseline preoperatively
measure: UCLA Activity Score Questionnaire Score
timeFrame: 2 weeks after surgery
measure: VR-12 Mental Health Questionnaire Score
timeFrame: Baseline preoperatively
measure: VR-12 Mental Health Questionnaire Score
timeFrame: 2 weeks after surgery
measure: VR-12 Physical Health Questionnaire Score
timeFrame: Baseline preoperatively
measure: VR-12 Physical Health Questionnaire Score
timeFrame: 2 weeks after surgery
measure: HOOS - Short Form Total Score Questionnaire Score
timeFrame: Baseline preoperatively
measure: HOOS - Short Form Total Score Questionnaire Score
timeFrame: 2 weeks after surgery
measure: iHOT-12 Questionnaire Score
timeFrame: Baseline preoperatively
measure: iHOT-12 Questionnaire Score
timeFrame: 2 weeks after surgery
measure: PROMIS v1.1 Pain Interference Questionnaire Score
timeFrame: Baseline preoperatively
measure: PROMIS v1.1 Pain Interference Questionnaire Score
timeFrame: 2 weeks after surgery
measure: PROMIS v1.0 Pain Intensity 3a Questionnaire Score
timeFrame: Baseline preoperatively
measure: PROMIS v1.0 Pain Intensity 3a Questionnaire Score
timeFrame: 2 weeks after surgery
measure: PROMIS v1.2 Physical Function Questionnaire Score
timeFrame: Baseline preoperatively
measure: PROMIS v1.2 Physical Function Questionnaire Score
timeFrame: 2 weeks after surgery
measure: PROMIS v2.0 Ability to Participate Socially Questionnaire Score
timeFrame: Baseline preoperatively
measure: PROMIS v2.0 Ability to Participate Socially Questionnaire Score
timeFrame: 2 weeks after surgery
measure: PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
timeFrame: Baseline preoperatively
measure: PROMIS v2.0 Satisfaction with Roles and Activities Questionnaire Score
timeFrame: 2 weeks after surgery
Other outcomes:
measure: Time to Discharge
timeFrame: Up to 1 day (day of surgery)
measure: Percentage of patients reporting falls in the first 24 hours after surgery
timeFrame: 24 hours after surgery
Locations:
Study officials:
affiliation: Columbia University Department of Orthopedics
name: Thomas S Lynch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: La Colla L, Ben-David B, Merman R. Quadratus Lumborum Block as an Alternative to Lumbar Plexus Block for Hip Surgery: A Report of 2 Cases. A A Case Rep. 2017 Jan 1;8(1):4-6. doi: 10.1213/XAA.0000000000000406.
citation: La Colla L, Uskova A, Ben-David B. Single-shot Quadratus Lumborum Block for Postoperative Analgesia After Minimally Invasive Hip Arthroplasty: A New Alternative to Continuous Lumbar Plexus Block? Reg Anesth Pain Med. 2017 Jan/Feb;42(1):125-126. doi: 10.1097/AAP.0000000000000523. No abstract available.
citation: Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.