NCT01907191

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2019

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 19, 2022

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

5.6 years

First QC Date

June 28, 2013

Results QC Date

May 27, 2022

Last Update Submit

August 12, 2022

Conditions

Keywords

Hip ArthroscopyLiposomal BupivacaineBupivacaine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pain Scores

    Post Operative Day 1, 2 & 3

Other Outcomes (2)

  • Number of Patients Reporting Sleep Disturbance

    Post Operative Day 1, 2 & 3

  • Satisfaction With Pain Management

    Post Operative Day 1, 2 & 3

Study Arms (2)

Liposomal bupivacaine

EXPERIMENTAL

Ultrasound guided injection of liposomal bupivacaine for patients undergoing hip arthroscopy

Drug: liposomal bupivacaine

Bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Interventions

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

Also known as: Exparel
Liposomal bupivacaine

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

Also known as: Marcaine
Bupivacaine

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having hip arthroscopy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Hip Injuries

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Limitations and Caveats

Study was terminated early leading to limited number of study subjects.

Results Point of Contact

Title
Sanjay Sinha, MD
Organization
Saint Francis Hospital and Medical Center

Study Officials

  • Sanjay Sinha, MD

    Saint Francis Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 24, 2013

Study Start

July 1, 2013

Primary Completion

January 30, 2019

Study Completion

January 30, 2019

Last Updated

August 16, 2022

Results First Posted

July 19, 2022

Record last verified: 2022-08

Locations