N/A
N=50
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Strabismus
Bottom Line
View on ClinicalTrials.gov: NCT01812044 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale — 6.36; 6.57; 6.58 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale |
6.36; 6.57; 6.58 | — |
| SECONDARY Peak Pain Score |
8.65; 10.47; 9.69 | 0.035 sig |
| SECONDARY Total Narcotic Use During Post-operative Recovery |
1.65; 1.78; 1.60 | — |
| SECONDARY Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) |
80.2; 78.2; 78.5 | — |
| SECONDARY Average Time to Discharge |
106; 107; 106 | — |
| SECONDARY Number of Participants With Post Operative Nausea and Vomiting |
1; 1; 1 | — |
| SECONDARY Number of Participants Who Required Anti-emetic Medication Post-operatively |
1; 1; 1 | — |
| SECONDARY Peak Pain Score During First 30 Minutes |
7.0; 7.8; 8.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01812044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.