Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial (LPB Hip Scope)

This study has been completed.
Sponsor:
Collaborator:
New York Presbyterian Hospital
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01286805
First received: January 28, 2011
Last updated: May 1, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Postoperative Pain
Procedure: Lumbar Plexus Blockade
Procedure: Control
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Readiness to Discharge From Post-Anesthesia Care Unit (PACU) [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
    Time to readiness for discharge from the PACU. Patients were considered ready for PACU discharge when they met the following criteria: a) Awake, alert, oriented and responsive b) Minimal pain, Numeric Rating Scale < 5/10 (0 = no pain, 10 = worst imaginable pain) (parenteral [injected] medications not required) c) Vital signs stable d) No active bleeding e) Minimal or no nausea f) Not vomiting, tolerating oral intake g) Oxygen saturation > 94% (or baseline) on room air h) Patient has urinated.

  • Narcotic Pain Medication Needed [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
  • Incidence of Nausea [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
    The number of participants with nausea.

  • Incidence of Vomiting [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
    The number of participants who vomited.

  • Requirement of Antiemetic Rescue [ Time Frame: Day of surgery prior to discharge ] [ Designated as safety issue: No ]
    The number of participants who needed medication to treat their nausea and vomiting.

  • Patient Satisfaction [ Time Frame: First 24 hours after surgery ] [ Designated as safety issue: No ]
    Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)

  • Quality of Recovery (QoR-40) Physical Comfort Dimension [ Time Frame: First 24 hours after surgery ] [ Designated as safety issue: No ]
    Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome


Enrollment: 83
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lumbar Plexus Blockade + CSE
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
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
Other Name: Marcaine
Placebo Comparator: Control Group
The control group will receive only a combined spinal-epidural.
Procedure: Control
The control group will receive only a combined spinal-epidural.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286805

Locations
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
New York Presbyterian Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Hospital for Special Surgery, New York
New York Presbyterian Hospital
Investigators
Principal Investigator: Jacques T YaDeau, M.D., Ph.D. Hospital for Special Surgery, New York
  More Information

Additional Information:
No publications provided

Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01286805     History of Changes
Other Study ID Numbers: 10038
Study First Received: January 28, 2011
Results First Received: July 23, 2012
Last Updated: May 1, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on April 22, 2014