Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

NCT ID: NCT01812044

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31

Brief 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.

Conditions

Strabismus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

subtenons anesthetic and topical control

Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery

Group Type: OTHER

subtenons anesthetic - preservative-free bupivacaine 0.75%

Intervention Type: DRUG

topical control - 0.5 cc of Hypromellose 0.3% gel

Intervention Type: DRUG

topical anesthetic and subtenons control

Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery

Group Type: OTHER

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

Intervention Type: DRUG

subtenons control - 0.5 cc of Normal Saline

Intervention Type: DRUG

topical control and subtenons control

Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery

Group Type: OTHER

topical control - 0.5 cc of Hypromellose 0.3% gel

Intervention Type: DRUG

subtenons control - 0.5 cc of Normal Saline

Intervention Type: DRUG

Interventions

subtenons anesthetic - preservative-free bupivacaine 0.75%

Intervention Type: DRUG

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

Intervention Type: DRUG

topical control - 0.5 cc of Hypromellose 0.3% gel

Intervention Type: DRUG

subtenons control - 0.5 cc of Normal Saline

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura Enyedi, MD

Role: PRINCIPAL_INVESTIGATOR

Duke Eye Center

Locations

Duke Eye Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00033000

Identifier Type: -

Identifier Source: org_study_id