Trial Outcomes & Findings for Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery (NCT NCT01812044)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

57 participants

Primary outcome timeframe

0-30 minutes post-operative

Results posted on

2016-04-26

Participant Flow

57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.

Participant milestones

Participant milestones
Measure	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 subtenons anesthetic - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	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 topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	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 topical control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Overall Study STARTED	17	17	16
Overall Study COMPLETED	17	17	16
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline	Total n=50 Participants Total of all reporting groups
Age, Continuous	53.6 months n=5 Participants	50.1 months n=7 Participants	60.9 months n=5 Participants	54.9 months n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale	6.36 units on a scale Standard Deviation 0.97	6.57 units on a scale Standard Deviation 1.06	6.58 units on a scale Standard Deviation 0.51

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Peak Pain Score	8.65 units on a scale Standard Deviation 2.42	10.47 units on a scale Standard Deviation 2.27	9.69 units on a scale Standard Deviation 2.15

SECONDARY outcome

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

This secondary outcome will include total narcotic use

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Total Narcotic Use During Post-operative Recovery	1.65 mcg/kg Standard Deviation 0.61	1.78 mcg/kg Standard Deviation 0.66	1.60 mcg/kg Standard Deviation .077

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)	80.2 units on a scale Standard Deviation 7.8	78.2 units on a scale Standard Deviation 10.9	78.5 units on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: 0-150 minutes post-operative

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Average Time to Discharge	106 minutes Standard Deviation 16	107 minutes Standard Deviation 25	106 minutes Standard Deviation 21

SECONDARY outcome

Timeframe: 0-150 minutes post-operative

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Number of Participants With Post Operative Nausea and Vomiting	1 participants	1 participants	1 participants

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Number of Participants Who Required Anti-emetic Medication Post-operatively	1 participants	1 participants	1 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Subtenons Anesthetic and Topical Control n=17 Participants 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 - preservative-free bupivacaine 0.75% topical control - 0.5 cc of Hypromellose 0.3% gel	Topical Anesthetic and Subtenons Control n=17 Participants 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 anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel subtenons control - 0.5 cc of Normal Saline	Topical Control and Subtenons Control n=16 Participants 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 control - 0.5 cc of Hypromellose 0.3% gel subtenons control - 0.5 cc of Normal Saline
Peak Pain Score During First 30 Minutes	7.0 units on a scale Standard Deviation 1.9	7.8 units on a scale Standard Deviation 2.4	8.3 units on a scale Standard Deviation 2.7

Adverse Events

Subtenons Anesthetic and Topical Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Anesthetic and Subtenons Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Topical Control and Subtenons Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Laura Enyedi, M.D.

Duke University Medical Center

Phone: 919-684-2038

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place