Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Duke University

Status: Completed

Conditions: Strabismus

Treatments: Drug: topical control - 0.5 cc of Hypromellose 0.3% gel; Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%; Drug: subtenons control - 0.5 cc of Normal Saline; Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01812044

Pro00033000

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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57 participants in 3 patient groups

subtenons anesthetic and topical control

Other group

Description:

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

Treatment:

Drug: topical control - 0.5 cc of Hypromellose 0.3% gel

Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%

topical anesthetic and subtenons control

Other group

Description:

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

Treatment:

Drug: subtenons control - 0.5 cc of Normal Saline

Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel

topical control and subtenons control

Other group

Description:

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

Treatment:

Drug: topical control - 0.5 cc of Hypromellose 0.3% gel

Drug: subtenons control - 0.5 cc of Normal Saline