The Role of Nerve Blocks in Hip Arthroscopy

NCT03506620 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: AAAR7247
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Femoroacetabular Impingement

Keywords

femoroacetabular impingement; hip arthroscopy; QL nerve block

Outcome Measures

Primary Outcomes (19)

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  0.5 hour

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  1 hour

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  1.5 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  2 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  4 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  6 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  12 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  24 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  48 hours

• Pain Score

  Patients will record their numerical pain score on a scale of 0 to 10 (0 = no pain, 10 = worst pain imaginable)

  7 days

• Oral Morphine Equivalents

  Opioid consumption following surgery as self reported by patients, measured in mg

  24 hours after surgery

• Oral Morphine Equivalents

  Opioid consumption following surgery as self reported by patients, measured in mg

  48 hours after surgery

• Oral Morphine Equivalents

  Opioid consumption following surgery as self reported by patients, measured in mg

  7 days after surgery

• Patient Satisfaction Score

  Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)

  24 hours after surgery

• Patient Satisfaction Score

  Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)

  48 hours after surgery

• Patient Satisfaction Score

  Patients will record their satisfaction following surgery on a scale of 0-10 (0 being not satisfied, 10 being fully satisfied)

  7 days after surgery

• Percentage of Patients Reporting Nausea and/or Vomiting

  Patients will self report any instances of nausea and/or vomiting

  24 hours after surgery

• Percentage of Patients Reporting Nausea and/or Vomiting

  Patients will self report any instances of nausea and/or vomiting

  48 hours after surgery

• Percentage of Patients Reporting Nausea and/or Vomiting

  Patients will self report any instances of nausea and/or vomiting

  7 days after surgery

Secondary Outcomes (32)

• HOS-ADL Questionnaire Score

  Baseline preoperative

• HOS-ADL Questionnaire Score

  2 weeks after surgery

• mHHS Questionnaire Score

  Baseline preoperative

• mHHS Questionnaire Score

  2 weeks after surgery

• HOOS - Symptoms and Stiffness Questionnaire Score

  Baseline preoperatively

Other Outcomes (2)

• Time to Discharge

  Up to 1 day (day of surgery)

• Percentage of patients reporting falls in the first 24 hours after surgery

  24 hours after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Subjects will be randomized to receive a single-injection QL block with normal saline (Saline Solution for Injection).

Drug: Saline Solution for Injection

QL Block

EXPERIMENTAL

Subjects will be randomized to receive a single-injection QL block with either local anesthetic (0.25% Ropivacaine injection).

Drug: Ropivacaine injection

Interventions

Ropivacaine injection DRUG

Naropin (Ropivacaine HCl) 0.25%; Dose: 20 cc

Also known as: Naropin

QL Block

Saline Solution for Injection DRUG

20 cc of saline will be injected in the form of a QL block as a placebo.

Also known as: Normal Saline

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Related Publications (3)

• 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.

  PMID: 28036319 BACKGROUND

• 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.

  PMID: 27997495 BACKGROUND

• 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.

  PMID: 28609336 BACKGROUND

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Ropivacaine; Saline Solution; Injections

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Thomas S Lynch, M.D.

  Columbia University Department of Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The anesthesiologist, surgeon, and patient will all be blinded to the intervention. After patients consent to join the study, a member of the study team who is not involved in patient care will randomly allocate patients to 1 of 2 groups, the intervention or the controls. A statistician not involved with the study will creat a randomization table and coordinate with the Research Pharmacy to keep the study team blinded. Naropin (Ropivacaine) will be dispensed by the research pharmacy. The nurse will prepare the study injection accordingly for the blind anesthesiologist to administer. The QL block will be administered by a trained musculoskeletal regional anesthesia specialist before the standard induction of general anesthesia. The injection will occur under sedation to minimize discomfort for the patient. The QL block group's injection will consist of 20 cc of 0.25% Ropivacaine, whereas the control group will receive 20 cc of saline.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: April 24, 2018
• Study Start: January 1, 2019
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share