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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Lumbar Plexus Blockade; Procedure: Control

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)	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.	Day of surgery prior to discharge
Narcotic Pain Medication Needed		Day of surgery prior to discharge
Incidence of Nausea	The number of participants with nausea.	Day of surgery prior to discharge
Incidence of Vomiting	The number of participants who vomited.	Day of surgery prior to discharge
Requirement of Antiemetic Rescue	The number of participants who needed medication to treat their nausea and vomiting.	Day of surgery prior to discharge
Patient Satisfaction	Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)	First 24 hours after surgery
Quality of Recovery (QoR-40) Physical Comfort Dimension	Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome	First 24 hours after surgery

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: New York Presbyterian Hospital

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: January 28, 2011
• First Submitted That Met QC Criteria: January 28, 2011
• First Posted (Estimate): January 31, 2011

Study Record Updates

• Last Update Posted (Estimate): June 5, 2013
• Last Update Submitted That Met QC Criteria: May 1, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 10038 (DAIDS ES)