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Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Primary Purpose

Strabismus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
subtenons anesthetic - preservative-free bupivacaine 0.75%
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
topical control - 0.5 cc of Hypromellose 0.3% gel
subtenons control - 0.5 cc of Normal Saline
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Strabismus

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Eye Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

subtenons anesthetic and topical control

topical anesthetic and subtenons control

topical control and subtenons control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Total Narcotic Use During Post-operative Recovery
This secondary outcome will include total narcotic use
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
Average Time to Discharge
Number of Participants With Post Operative Nausea and Vomiting
Number of Participants Who Required Anti-emetic Medication Post-operatively
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.

Full Information

First Posted
March 13, 2013
Last Updated
March 24, 2016
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT01812044
Brief Title
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Official Title
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subtenons anesthetic and topical control
Arm Type
Other
Arm Description
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
Arm Title
topical anesthetic and subtenons control
Arm Type
Other
Arm Description
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
Arm Title
topical control and subtenons control
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
subtenons anesthetic - preservative-free bupivacaine 0.75%
Intervention Type
Drug
Intervention Name(s)
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
Intervention Type
Drug
Intervention Name(s)
topical control - 0.5 cc of Hypromellose 0.3% gel
Intervention Type
Drug
Intervention Name(s)
subtenons control - 0.5 cc of Normal Saline
Primary Outcome Measure Information:
Title
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
Description
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 Outcome Measure Information:
Title
Peak Pain Score
Description
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
Title
Total Narcotic Use During Post-operative Recovery
Description
This secondary outcome will include total narcotic use
Time Frame
Total time in post-operative recovery - up to 6 hours
Title
Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)
Description
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
Time Frame
1 week (+/- 3 days) post operatively
Title
Average Time to Discharge
Time Frame
0-150 minutes post-operative
Title
Number of Participants With Post Operative Nausea and Vomiting
Time Frame
0-150 minutes post-operative
Title
Number of Participants Who Required Anti-emetic Medication Post-operatively
Time Frame
Total time in post-operative recovery - up to 6 hours
Title
Peak Pain Score During First 30 Minutes
Description
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.
Time Frame
0-30 minutes post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Enyedi, MD
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

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