Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Not Applicable

Completed

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

• Registration Number: NCT01812044
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-13
• Study First Submitted QC: 2013-03-13
• Study First Posted: 2013-03-15
• Primary Completion: 2014-12
• Results First Submitted: 2015-12-01
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-24
• Last Update Submitted: 2016-03-24
• Results First Posted: 2016-04-26
• Last Update Posted: 2016-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
topical control and subtenons control	subtenons control - 0.5 cc of Normal Saline	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
topical anesthetic and subtenons control	subtenons control - 0.5 cc of Normal Saline	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
subtenons anesthetic and topical control	subtenons anesthetic - preservative-free bupivacaine 0.75%	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
subtenons anesthetic and topical control	topical control - 0.5 cc of Hypromellose 0.3% gel	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
topical anesthetic and subtenons control	topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel	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
topical control and subtenons control	topical control - 0.5 cc of Hypromellose 0.3% gel	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

Primary Outcome Measures

Name	Time	Method
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale	0-30 minutes post-operative	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Required Anti-emetic Medication Post-operatively	Total time in post-operative recovery - up to 6 hours
Total Narcotic Use During Post-operative Recovery	Total time in post-operative recovery - up to 6 hours	This secondary outcome will include total narcotic use
Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)	1 week (+/- 3 days) post operatively	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
Peak Pain Score During First 30 Minutes	0-30 minutes post-operative	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.
Peak Pain Score	0-150 minutes post-operative	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.
Average Time to Discharge	0-150 minutes post-operative
Number of Participants With Post Operative Nausea and Vomiting	0-150 minutes post-operative

Trial Locations

Locations (1)

Duke Eye Center; 🇺🇸 Durham, North Carolina, United States