Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

N/ACompletedNCT01812044

Duke University57 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Strabismus

Interventions

subtenons anesthetic - preservative-free bupivacaine 0.75%DRUG

topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gelDRUG

topical control - 0.5 cc of Hypromellose 0.3% gelDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 7 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke Eye Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. Pain is rated every 5 minutes for the first 30 minutes postoperatively. Each pain score collected in the first 30 minutes was averaged to calculate a per per participant average pain score over the first 30 minutes . Then each participant's per participant average pain score was combined to calculate the reported mean for "Average pain score over the first 30 post-operative minutes using the CHEOPS scale." for each group.

Time frame: 0-30 minutes post-operative

Secondary Outcomes

Peak Pain Score

This secondary outcome will include the peak pain score for duration of follow up period. Pain will be assessed by masked observers, using the CHEOPS scale. The CHEOPS (Children's Hospital of Eastern Ontario Pain Scale) is a behavioral scale for evaluating postoperative pain in young children. The scale is assessed using the sum of a score for cry (1-3), facial expression (0-2), verbalization (0-2), torso (1-2), touch (1-2) and legs (1-2). The minimum score is 4, the maximum score is 13, and higher scores indicate more pain. A pain score was assessed and recorded every 5 minutes by a masked observer (clinical research coordinator) for the first 30 minutes after extubation, then every 15 minutes for the next hour, then, if applicable, hourly until discharge.

Time frame: 0-150 minutes post-operative

Total Narcotic Use During Post-operative Recovery

This secondary outcome will include total narcotic use

Time frame: Total time in post-operative recovery - up to 6 hours

Data from ClinicalTrials.gov

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