Phase 4
N=83
Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT01286805 ↗Enrolled (actual)
83
Serious AEs
6.0%
Results posted
Jun 2013
Primary outcome: Primary: Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge — 3.3; 4.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lumbar Plexus Blockade (Procedure); Control (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale (NRS) Pain at Rest (0-10) on Day of Surgery Prior to Discharge |
3.3; 4.2 | — |
| SECONDARY Readiness to Discharge From Post-Anesthesia Care Unit (PACU) |
216; 187 | — |
| SECONDARY Narcotic Pain Medication Needed |
21; 29 | — |
| SECONDARY Incidence of Nausea |
14; 8 | — |
| SECONDARY Incidence of Vomiting |
1; 3 | — |
| SECONDARY Requirement of Antiemetic Rescue |
5; 5 | — |
| SECONDARY Patient Satisfaction |
8.6; 7.9 | — |
| SECONDARY Quality of Recovery (QoR-40) Physical Comfort Dimension |
53; 52 | — |
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
Data sourced from ClinicalTrials.gov (NCT01286805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.