Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial

NCT01286805 | Completed Phase 4 Results DMC

• 1 other identifier: 10038
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge

  The Numeric Rating Scale was used to ask patients to rate their pain at rest on a scale of 0 to 10, 0 = no pain and 10 = worst pain imaginable.

  Day of surgery prior to discharge

Secondary Outcomes (7)

• Readiness to Discharge From Post-Anesthesia Care Unit (PACU)

  Day of surgery prior to discharge

• Narcotic Pain Medication Needed

  Day of surgery prior to discharge

• Incidence of Nausea

  Day of surgery prior to discharge

• Incidence of Vomiting

  Day of surgery prior to discharge

• Requirement of Antiemetic Rescue

  Day of surgery prior to discharge

Study Arms (2)

Lumbar Plexus Blockade + CSE

EXPERIMENTAL

The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.

Procedure: Lumbar Plexus Blockade

Control Group

PLACEBO COMPARATOR

The control group will receive only a combined spinal-epidural.

Procedure: Control

Interventions

Lumbar Plexus Blockade PROCEDURE

The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine

Also known as: Marcaine

Lumbar Plexus Blockade + CSE

Control PROCEDURE

The control group will receive only a combined spinal-epidural.

Control Group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) Class 1-3
• Patients aged 18 to 65 years
• Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
• Planned use of neuraxial anesthesia
• Body Mass Index less than 35
• Ability to follow study protocol

You may not qualify if:

• Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months)
• Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
• Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
• Infection at the injection site(s)
• Allergy to any of the study medications
• Contraindication to a short course of NSAIDs (renal failure, intolerance)
• ASA Class 4-5
• Patient refusal
• Patients younger than 18 years old and older than 65
• Patients with any known indwelling hardware of the lumbar spine.
• Patients with a peripheral neuropathy of the surgical extremity
• Non-English speaking patients

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• New York Presbyterian Hospital: collaborator

Study Sites (2)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Related Links

• This is the link for the Hospital for Special Surgery website

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Jacques YaDeau
• Organization: Hospital for Special Surgery

yadeauj@hss.edu

212-606-1206

Study Officials

• Jacques T YaDeau, M.D., Ph.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2011
• First Posted: January 31, 2011
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: May 1, 2011
• Last Updated: June 5, 2013
• Results First Posted: June 5, 2013

Record last verified: 2013-05

Locations

US (2)