Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

Comparison of Bupivacaine to Liposomal Bupivacaine for Ultrasound Guided Periarticular Hip Infiltration for Postoperative Analgesia After Hip Arthroscopy.

This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours

Study Overview

• Status: Terminated
• Conditions: Hip Injuries
• Intervention / Treatment: Drug: liposomal bupivacaine; Drug: Bupivacaine

Detailed Description

Patients undergoing hip arthroscopy experience moderate to severe postoperative pain. Effective pain control after surgery is an important component in the overall management of these patients. Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction. Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications. Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Saint Francis Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients having hip arthroscopy

Exclusion Criteria:

• History of neurologic disease, neuropathy, diabetes
• Allergy to local anesthetic solution
• Chronic use of narcotics
• Inability to give consent/cooperate with study
• History of previous hip arthroscopy on the ipsilateral side
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal bupivacaine; Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy	Drug: liposomal bupivacaine; (Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy; Other Names: Exparel
Active Comparator: Bupivacaine; Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy	Drug: Bupivacaine; (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)	Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3.	Post Operative Day 1, 2 & 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	Analysis of pain scores (at rest and ambulation) during hospital stay. Measured on a 10 point pain scale (1 being no pain and 10 being worst pain imaginable)	Post Operative Day 1, 2 & 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients Reporting Sleep Disturbance	Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 & 3)	Post Operative Day 1, 2 & 3
Satisfaction With Pain Management	Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)	Post Operative Day 1, 2 & 3

Collaborators and Investigators

• Sponsor: Saint Francis Care
• Investigators: Principal Investigator: Sanjay Sinha, MD, Saint Francis Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): January 30, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: June 28, 2013
• First Submitted That Met QC Criteria: July 18, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Actual): August 16, 2022
• Last Update Submitted That Met QC Criteria: August 12, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Bupivacaine; Hip Arthroscopy; Liposomal Bupivacaine
• Additional Relevant MeSH Terms: Wounds and Injuries; Hip Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 13-06-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No