Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

NCT ID: NCT01907191

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-01-30

Brief Summary

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

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.

Conditions

Hip Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Liposomal bupivacaine

Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy

Group Type: EXPERIMENTAL

liposomal bupivacaine

Intervention Type: DRUG

(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy

Bupivacaine

Bupivacaine (around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy

Interventions

liposomal bupivacaine

(Ultrasound guided injection of liposomal bupivacaine) for patients undergoing hip arthroscopy

Intervention Type: DRUG

Bupivacaine

(around the anterior, lateral and medial aspect of hip joint) for patients undergoing hip arthroscopy

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Trinity Health Of New England

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjay Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Francis Hospital and Medical Center

Locations

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13-06-001

Identifier Type: -

Identifier Source: org_study_id