PatientsVille.com LogoPatientsVille.com

Strabismus | Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Strabismus research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Strabismus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:subtenons anesthetic - preservative-free bupivacaine 0.75%

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

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

Drug:subtenons control - 0.5 cc of Normal Saline

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

subtenons anesthetic and topical controlGroup 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

topical anesthetic and subtenons controlGroup 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

topical control and subtenons controlGroup 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

Study Status

Completed

Start Date: March 2013

Completed Date:

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale

Secondary Outcome: Peak Pain Score

Study sponsors, principal investigator, and references

Principal Investigator: Laura Enyedi, MD

Lead Sponsor: Duke University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01812044

Discuss Genteal