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

Phase 4
Completed
Conditions
Postoperative Pain
Interventions
Procedure: Lumbar Plexus Blockade
Procedure: Control
Registration Number
NCT01286805
Lead Sponsor
Hospital for Special Surgery, New York
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
83
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lumbar Plexus Blockade + CSELumbar Plexus BlockadeThe 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.
Control GroupControlThe control group will receive only a combined spinal-epidural.
Primary Outcome Measures
NameTimeMethod
Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to DischargeDay 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.

Secondary Outcome Measures
NameTimeMethod
Readiness to Discharge From Post-Anesthesia Care Unit (PACU)Day of surgery prior to discharge

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 NeededDay of surgery prior to discharge
Incidence of NauseaDay of surgery prior to discharge

The number of participants with nausea.

Incidence of VomitingDay of surgery prior to discharge

The number of participants who vomited.

Requirement of Antiemetic RescueDay of surgery prior to discharge

The number of participants who needed medication to treat their nausea and vomiting.

Patient SatisfactionFirst 24 hours after surgery

Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)

Quality of Recovery (QoR-40) Physical Comfort DimensionFirst 24 hours after surgery

Assessment of Physical Comfort (minimum score = 12, maximum score = 60). Higher values represent a better outcome

Trial Locations

Locations (2)

New York Presbyterian Hospital

🇺🇸

New York, New York, United States

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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