Exparel Injection for Postoperative Orbital Pain

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT02381353

Collaborator

(none)

Enrollment

Location

Arms

118

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Bupivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

Postoperative Pain Control After Enucleation or Evisceration, a Double-Masked Randomized Controlled Trial of Standard Versus Slow-release Bupivacaine

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Plain bupivacaine Intraoperative injection of local anesthetic agent, standard of care	Drug: Bupivacaine Intraoperative orbital injection of local pain medication Other Names: Exparel
Experimental: Exparel (sustained release bupivacaine) Intraoperative injection of local anesthetic agent, long acting agent	Drug: Bupivacaine Intraoperative orbital injection of local pain medication Other Names: Exparel

Arm

Intervention/Treatment

Active Comparator: Plain bupivacaine

Intraoperative injection of local anesthetic agent, standard of care

Drug: Bupivacaine

Intraoperative orbital injection of local pain medication

Other Names:

Exparel

Experimental: Exparel (sustained release bupivacaine)

Intraoperative injection of local anesthetic agent, long acting agent

Drug: Bupivacaine

Intraoperative orbital injection of local pain medication

Other Names:

Exparel

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative nausea and vomiting [Days 3 postoperatively]
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 [Days 3 postoperatively]
Number of oral narcotic pills taken during postoperative days 0-3
Patient satisfaction [Day 3 postoperatively]
Overall satisfaction with postoperative recovery, assessed on a scale of 1-5
Postoperative complications [6-8 weeks postoperatively]
Assessment of any postsurgical complications completed at postoperative visit

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.