Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Strabismus Clinical Trial

Official title:

Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01812044
• Other study ID #: Pro00033000
• Status: Completed
• Phase: N/A
• First received: March 13, 2013
• Last updated: December 15, 2014
• Start date: March 2013

Study information

• Verified date: December 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if local anesthetic, either a subtenons injection (an injection just beneath the surface tissue of the eye) or a topical ophthalmic gel (applied directly on the surface of the eye) given at the end of strabismus surgery reduces postoperative pain. Some surgeons routinely use either the subtenon and/or topical anesthetic for pain at the end of strabismus surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• Age 1 year to < 8 years

• Undergoing strabismus surgery under general anesthesia

• No previous surgery on muscle to be operated

• No known allergy to lidocaine or bupivacaine

• Investigator willing to inject subtenons NS or preservative-free bupivacaine 0.75% by cannula into all surgical wounds and willing to administer topical lidocaine 3.5% ophthalmic gel or Hypromellose 0.3% gel (GenTeal Severe Dry Eye Relief) to all surgical wounds at the end of strabismus surgery.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pain, Postoperative
• Strabismus

Intervention

Drug:
• subtenons anesthetic - preservative-free bupivacaine 0.75%

• topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

• topical control - 0.5 cc of Hypromellose 0.3% gel

• subtenons control - 0.5 cc of Normal Saline

Locations

Country	Name	City	State
United States	Duke Eye Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average pain score over the first 30 post-operative minutes using the CHEOPS scale	Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. Pain is rated every 5 minutes for the first 30 minutes postoperatively.	0-30 minutes post-operative	No
Secondary	Peak pain score in the first 30 minutes	This secondary outcome will include the peak pain score in the first 30 minutes. Pain will be assessed by masked observers, using the CHEOPS scale. Pain is rated every 5 minutes for the first 30 minutes postoperatively.	0-30 minutes post-operative	No
Secondary	Total narcotic and anti-emetic use during post-operative recovery	This secondary outcome will include total narcotic use, total anti-emetic use, and nausea or vomiting gathered from the anesthesia report from the Anesthesiologist.	Total time in post-operative recovery - up to 6 hours	No
Secondary	Negative postoperative behavior score on the PHBQ (post hospitalization behavioral questionnaire)	This secondary outcome will determine the negative postoperative behaviors based on the PHBQ questionnaire given to the parents of the child 1 week (+/- 3 days) post-operatively.	1 week (+/- 3 days) post operatively	No
Secondary	Change in pain score	Pain scores after 30 minutes will be measured. Pain will be assessed by masked observers, using the CHEOPS scale. Pain is rated: every 15 minutes for the next hour; if applicable, hourly until discharge home	30 minutes post-operative to discharge home	No