Clinical trial NCT01286805: Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Official title: Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: New York Presbyterian Hospital
First posted: 2011-01-31
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge
timeFrame: Day of surgery prior to discharge
Secondary outcomes:
measure: Readiness to Discharge From Post-Anesthesia Care Unit (PACU)
timeFrame: Day of surgery prior to discharge
measure: Narcotic Pain Medication Needed
timeFrame: Day of surgery prior to discharge
measure: Incidence of Nausea
timeFrame: Day of surgery prior to discharge
measure: Incidence of Vomiting
timeFrame: Day of surgery prior to discharge
measure: Requirement of Antiemetic Rescue
timeFrame: Day of surgery prior to discharge
measure: Patient Satisfaction
timeFrame: First 24 hours after surgery
measure: Quality of Recovery (QoR-40) Physical Comfort Dimension
timeFrame: First 24 hours after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jacques T YaDeau, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: