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Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

Primary Purpose

Hip Injuries

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

liposomal bupivacaine

Bupivacaine

About this trial

This is an interventional treatment trial for Hip Injuries focused on measuring Hip Arthroscopy, Liposomal Bupivacaine, Bupivacaine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Saint Francis Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liposomal bupivacaine

Bupivacaine

Arm Description

Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy

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

Outcomes

Primary Outcome Measures

Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)

Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01907191

First Posted

June 28, 2013

Last Updated

August 12, 2022

Sponsor

Trinity Health Of New England

1. Study Identification

Unique Protocol Identification Number

NCT01907191

Brief Title

Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Terminated

Study Start Date

July 2013 (undefined)

Primary Completion Date

January 30, 2019 (Actual)

Study Completion Date

January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Trinity Health Of New England

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Injuries

Keywords

Hip Arthroscopy, Liposomal Bupivacaine, Bupivacaine

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Liposomal bupivacaine

Arm Type

Experimental

Arm Description

Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy

Arm Title

Bupivacaine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

liposomal bupivacaine

Other Intervention Name(s)

Exparel

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bupivacaine

Other Intervention Name(s)

Marcaine

Intervention Description

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

Primary Outcome Measure Information:

Title

Opioid Consumption (Mean Number of 5mg Oxycontin Tablets Consumed)

Description

Consumption of 5mg Oxycontin tablets will be assessed on Post Operative Days 1, 2 & 3.

Time Frame

Post Operative Day 1, 2 & 3

Secondary Outcome Measure Information:

Title

Pain Scores

Description

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)

Time Frame

Post Operative Day 1, 2 & 3

Other Pre-specified Outcome Measures:

Title

Number of Patients Reporting Sleep Disturbance

Description

Analysis of sleep disturbance during hospital stay (participants who reported being woken up by pain on post operative days 1, 2 & 3)

Time Frame

Post Operative Day 1, 2 & 3

Title

Satisfaction With Pain Management

Description

Analysis of satisfaction with pain management during hospital stay measured on a 15 point scale (1 being extremely unsatisfied to 15 being extremely satisfied)

Time Frame

Post Operative Day 1, 2 & 3

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Sinha, MD

Organizational Affiliation

Saint Francis Hospital and Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Saint Francis Hospital and Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06105

Country

United States

12. IPD Sharing Statement

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Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

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