Postoperative Pain Control After Enucleation or Evisceration

Eye Enucleation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03003741
• Other study ID #: HUM00096782
• Status: Terminated
• Phase: Phase 4
• Start date: August 31, 2015
• Est. completion date: April 16, 2018

Study information

• Verified date: May 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a new form of bupivacaine, called Exparel, which can be injected into the eye socket during surgery and may provide pain relief for up to 72 hours. The purpose of the study is to compare the plain bupivacaine injection to Exparel, to see if one medication works better than the other.

Description:

During eye removal surgery, bupivacaine is injected, which is a numbing medicine that helps with pain, but it lasts for only 4 to 8 hours. After eye removal, some patients have pain in the eye socket that lasts for several days or up to a week. While this pain can be treated with broad based prescription pain medication, but this may cause side effects, therefore if Exparel reduces the need for additional pain medication, patients may experience better recovery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: April 16, 2018
• Est. primary completion date: April 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years and older,

• Undergoing enucleation or evisceration of the eye,

• Willing and able to comprehend a numerical rating scale system and provide a score to assess pain, nausea, and satisfaction level.

Exclusion Criteria:

• Pregnant or nursing

Related Conditions & MeSH terms

• Eye Enucleation
• Eye Evisceration
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
One 4 cc intraorbital injection at the end of procedure
• EXPAREL
One 4 cc intraorbital injection at the end of procedure

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantity of oral opioid pain medication required	patient will be provided with a standard prescription of hydrocodone-acetaminophen (or alternate in the case of medication sensitivity) at the time of surgery and asked to report the remaining number of pills on postoperative day 3.	Day 3 post op
Other	Patient satisfaction level	assessed with a Likert scale where 1 is strongly dissatisfied and 5 is very satisfied.	Day 3 post op
Primary	Postoperative Pain on day 3	verbally reported numerical rating scale (NRS) of 0 to 10, where 0 is no pain and 10 is the most pain imaginable.	Day 3 post op
Secondary	Postoperative nausea	Nausea will be assessed on a Likert scale (0=no nausea, 1=mild, 2=moderate, 3=severe)).	Day 3 post op
Secondary	Postoperative vomiting	Vomiting will be recorded as present or absent (0=No, 1=Yes).	Day 3 post op