Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

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 Overview

• Status: Completed
• Conditions: Strabismus
• Intervention / Treatment: Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%; Drug: topical control - 0.5 cc of Hypromellose 0.3% gel; Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel; Drug: subtenons control - 0.5 cc of Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%; Drug: topical control - 0.5 cc of Hypromellose 0.3% gel
Other: 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	Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel; Drug: subtenons control - 0.5 cc of Normal Saline
Other: 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	Drug: topical control - 0.5 cc of Hypromellose 0.3% gel; Drug: subtenons control - 0.5 cc of Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-30 minutes post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-150 minutes post-operative
Total Narcotic Use During Post-operative Recovery	This secondary outcome will include total narcotic use	Total time in post-operative recovery - up to 6 hours
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. with a score of 81 indicating no change, a score of less than 81 indicating a change for the better, and a score of over 81 indicating a change for the worse, on average, in behavior. Lowest score 27; highest score 135	1 week (+/- 3 days) post operatively
Average Time to Discharge		0-150 minutes post-operative
Number of Participants With Post Operative Nausea and Vomiting		0-150 minutes post-operative
Number of Participants Who Required Anti-emetic Medication Post-operatively		Total time in post-operative recovery - up to 6 hours
Peak Pain Score During First 30 Minutes	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. Pain is rated every 5 minutes for the first 30 minutes postoperatively.	0-30 minutes post-operative

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Laura Enyedi, MD, Duke Eye Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 13, 2013
• First Submitted That Met QC Criteria: March 13, 2013
• First Posted (Estimate): March 15, 2013

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Cranial Nerve Diseases; Ocular Motility Disorders; Pain, Postoperative; Strabismus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Membrane Transport Modulators; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Anesthetics; Lidocaine; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PRO00033000