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

Postoperative Pain Clinical Trial

— LPB Hip Scope  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286805
• Other study ID #: 10038
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2011
• Last updated: May 1, 2013
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: May 2013
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Lumbar Plexus Blockade
The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
• Control
The control group will receive only a combined spinal-epidural.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York
United States	New York Presbyterian Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Narcotic Pain Medication Needed		Day of surgery prior to discharge	No
Secondary	Incidence of Nausea	The number of participants with nausea.	Day of surgery prior to discharge	No
Secondary	Incidence of Vomiting	The number of participants who vomited.	Day of surgery prior to discharge	No
Secondary	Requirement of Antiemetic Rescue	The number of participants who needed medication to treat their nausea and vomiting.	Day of surgery prior to discharge	No
Secondary	Patient Satisfaction	Patient Satisfaction (0-10; 0 = very dissatisfied, 10 = very satisfied)	First 24 hours after surgery	No
Secondary	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	No

External Links

•   This is the link for the Hospital for Special Surgery website