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Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

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ClinicalTrials.gov Identifier: NCT01812044
Recruitment Status : Completed
First Posted : March 15, 2013
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Strabismus
Interventions: Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%
Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
Drug: topical control - 0.5 cc of Hypromellose 0.3% gel
Drug: subtenons control - 0.5 cc of Normal Saline

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Subtenons Anesthetic and Topical Control   Topical Anesthetic and Subtenons Control   Topical Control and Subtenons Control
STARTED   17   17   16 
COMPLETED   17   17   16 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Subtenons Anesthetic and Topical Control   Topical Anesthetic and Subtenons Control   Topical Control and Subtenons Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   17   16   50 
Age 
[Units: Months]
Mean (Full Range)
 53.6 
 (13 to 87) 
 50.1 
 (19 to 91) 
 60.9 
 (27 to 89) 
 54.9 
 (13 to 91) 
Gender 
[Units: Participants]
       
Female   7   7   7   21 
Male   10   10   9   29 


  Outcome Measures

1.  Primary:   Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale   [ Time Frame: 0-30 minutes post-operative ]

2.  Secondary:   Peak Pain Score   [ Time Frame: 0-150 minutes post-operative ]

3.  Secondary:   Total Narcotic Use During Post-operative Recovery   [ Time Frame: Total time in post-operative recovery - up to 6 hours ]

4.  Secondary:   Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)   [ Time Frame: 1 week (+/- 3 days) post operatively ]

5.  Secondary:   Average Time to Discharge   [ Time Frame: 0-150 minutes post-operative ]

6.  Secondary:   Number of Participants With Post Operative Nausea and Vomiting   [ Time Frame: 0-150 minutes post-operative ]

7.  Secondary:   Number of Participants Who Required Anti-emetic Medication Post-operatively   [ Time Frame: Total time in post-operative recovery - up to 6 hours ]

8.  Secondary:   Peak Pain Score During First 30 Minutes   [ Time Frame: 0-30 minutes post-operative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Laura Enyedi, M.D.
Organization: Duke University Medical Center
phone: 919-684-2038
e-mail: laura.enyedi@dm.duke.edu



Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01812044     History of Changes
Other Study ID Numbers: Pro00033000
First Submitted: March 13, 2013
First Posted: March 15, 2013
Results First Submitted: December 1, 2015
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016