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Completed

NCT Number: NCT01286805

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar Plexus Blockade

Procedure

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

Other names: Marcaine

Control

Procedure

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

  2. Narcotic Pain Medication Needed

    Time frame: Day of surgery prior to discharge

  3. Incidence of Nausea

    Time frame: Day of surgery prior to discharge

    The number of participants with nausea.

  4. Incidence of Vomiting

    Time frame: Day of surgery prior to discharge

    The number of participants who vomited.

  5. Requirement of Antiemetic Rescue

    Time frame: Day of surgery prior to discharge

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

  6. Patient Satisfaction

    Time frame: First 24 hours after surgery

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

  7. Quality of Recovery (QoR-40) Physical Comfort Dimension

    Time frame: First 24 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

  • New York Presbyterian Hospital

Registry information

Acronym: LPB Hip Scope

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Jan 31, 2011
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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