Preemptive Femoral & Lateral Femoral Cutaneous Nerve Blocks for THA Acute Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of the study is to evaluate via a prospective, blinded, randomized clinical trial, whether ultrasound-guided single femoral and lateral femoral cutaneous nerve blocks with ropivacaine 0.5% with epinephrine (1:200,000) as a tracer for intravascular injection (total 30 ml) vs. saline with epinephrine (1:200,000) (total 30 ml), given just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain (NRS scores), postoperative opiate consumption, and time to discharge from the postanesthesia care unit. Differences between groups with respect to postoperative quality of life and functional scores will also be evaluated.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Nervus Cutaneous Femoris Lateralis-Blockade on Moderate Pain Responders After Total Hip Arthroplasty

NCT02344264

Pain, Postoperative Ropivacaine Therapeutic Use +1 more

COMPLETED PHASE4

Regional Anesthesia in Hip Arthroscopy

NCT02674113

Femoroacetabular Impingement

WITHDRAWN NA

Effect of a Lateral Nerve of the Thigh Block on Postoperative Pain After Total Hip Replacement Surgery

NCT02289937

Pain, Postoperative Anesthesia, Conduction Arthroplasty, Replacement, Hip

COMPLETED PHASE4

Ultrasound-Guided Obturator Nerve Block for Ambulatory Hip Arthroscopy

NCT02346357

Pain

UNKNOWN NA

The Role of Nerve Blocks in Hip Arthroscopy

NCT03506620

Femoroacetabular Impingement

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to evaluate whether ultrasound (using sound waves to produce an image)-guided regional anesthesia (local numbing medicine) to the hip area given in addition to general anesthesia just prior to same day elective hip arthroscopy, is effective in reducing acute postoperative pain, and time to discharge from the post anesthesia care unit. In addition, the study aims to examine whether this regional anesthesia medication has any effect on the study subjects' use of pain medication both during and after the procedure, return to function, and quality of life in the 6 month period after the surgical procedure. Although hip arthroscopy is a routine procedure, the best method for pain control is not well established, and is the purpose of this study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Internal Derangement of Hip Acetabular Labrum Tear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Grp 1 Ropivacaine Block

Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)

Grp 2 Placebo Block

Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ropivacaine

Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)

Intervention Type DRUG

Placebo

Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>18 year old,
* ASA physical status classification system score (ASA) \<=3
* due to undergo elective unilateral hip arthroscopy by one surgeon Dr. Nho (Co-Principal Investigator)

Exclusion Criteria

* ASA physical status classification system score) (ASA) \>3
* history of opioid dependence or abuse
* current chronic analgesic therapy (daily use =\>20 mg oxycodone-equivalent opioid use within 2 weeks before surgery and duration of use \>=4 weeks)
* allergy to study medications (fentanyl and ropivicaine)
* any neuromuscular deficit of the ipsilateral femoral nerve or quadriceps femoris muscle (including diabetic peripheral neuropathy)
* diagnosis of hypertension and/or current treatment for hypertension
* pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No