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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Lumbar Plexus Blockade
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumbar Plexus Blockade + CSE<br>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<br>* The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine<br>* Other names: Marcaine;|
| Placebo Comparator: Control Group<br>The control group will receive only a combined spinal-epidural. | Procedure: Control<br>* The control group will receive only a combined spinal-epidural.<br>|

What is the study measuring?
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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 |