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Exparel Injection for Postoperative Orbital Pain

Primary Purpose

Pain, Postoperative

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Enucleation, Evisceration, Exparel, bupivacaine

Eligibility Criteria

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

Inclusion criteria:

  1. All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester
  2. Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.

Exclusion criteria:

  1. Age less than 18 years (Exparel has not been tested in a pediatric population)
  2. Pregnant or nursing (Exparel has not been tested in this patient population)

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Plain bupivacaine

Exparel (sustained release bupivacaine)

Arm Description

Intraoperative injection of local anesthetic agent, standard of care

Intraoperative injection of local anesthetic agent, long acting agent

Outcomes

Primary Outcome Measures

Postoperative orbital pain
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration

Secondary Outcome Measures

Postoperative nausea and vomiting
Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration
Quantity of oral narcotics used for postoperative pain control
Number of oral narcotic pills taken during postoperative days 0-3
Patient satisfaction
Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Postoperative complications
Assessment of any postsurgical complications completed at postoperative visit

Full Information

First Posted
February 11, 2015
Last Updated
March 13, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT02381353
Brief Title
Exparel Injection for Postoperative Orbital Pain
Official Title
Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
After surgery to remove the eye, either by enucleation or evisceration, patients have variable levels of pain for several postoperative days. Some patients have almost no discomfort while others require significant amounts of oral narcotics and report pain of 10 out of 10 on a numerical rating scale. The current operative standard is to infiltrate the eye socket with 0.5% bupivacaine during surgery leading to several hours of postoperative analgesia. In 2011, Pacira Pharmaceuticals released a bupivacaine liposomal injectable suspension (Exparel, 1.3%) which offers sustained release of bupivacaine giving postoperative pain control for up to 72 hours. This medication has been used in numerous surgeries including inguinal hernia repair, hemorrhoidectomy, bunionectomy, breast reconstruction, and orthopedic surgery, and the literature reports improved pain control, decreased use of oral opioids, and increased patient satisfaction. There are no reports of the use of Exparel in the ophthalmic literature. The investigators propose a randomized, controlled trial to compare the postoperative pain control offered by sustained release bupivacaine to that offered by standard plain bupivacaine after enucleation or evisceration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Enucleation, Evisceration, Exparel, bupivacaine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Plain bupivacaine
Arm Type
Active Comparator
Arm Description
Intraoperative injection of local anesthetic agent, standard of care
Arm Title
Exparel (sustained release bupivacaine)
Arm Type
Experimental
Arm Description
Intraoperative injection of local anesthetic agent, long acting agent
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Exparel
Intervention Description
Intraoperative orbital injection of local pain medication
Primary Outcome Measure Information:
Title
Postoperative orbital pain
Description
Pain on a scale of 0-10, assessed on day 3 post enucleation or evisceration
Time Frame
Days 3 postoperatively
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
Nausea and vomiting on a scale of 0-3, assessed on day 3 post enucleation or evisceration
Time Frame
Days 3 postoperatively
Title
Quantity of oral narcotics used for postoperative pain control
Description
Number of oral narcotic pills taken during postoperative days 0-3
Time Frame
Days 3 postoperatively
Title
Patient satisfaction
Description
Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Time Frame
Day 3 postoperatively
Title
Postoperative complications
Description
Assessment of any postsurgical complications completed at postoperative visit
Time Frame
6-8 weeks postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: All patients undergoing enucleation or evisceration of the eye whose surgery is performed by the Department of Ophthalmology at Mayo Clinic Rochester Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level. Exclusion criteria: Age less than 18 years (Exparel has not been tested in a pediatric population) Pregnant or nursing (Exparel has not been tested in this patient population)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth A Bradley, MD
Phone
507-284-3340
Email
bradley.elizabeth@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Bradley, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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Exparel Injection for Postoperative Orbital Pain

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