Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
Overview
- Phase
- Not Applicable
- Intervention
- subtenons anesthetic - preservative-free bupivacaine 0.75%
- Conditions
- Strabismus
- Sponsor
- Duke University
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: subtenons anesthetic - preservative-free bupivacaine 0.75%
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
Intervention: 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
Intervention: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic 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
Intervention: 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
Intervention: topical control - 0.5 cc of Hypromellose 0.3% gel
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
Intervention: subtenons control - 0.5 cc of Normal Saline
Outcomes
Primary Outcomes
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale
Time Frame: 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 Outcomes
- 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)
- Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)(1 week (+/- 3 days) post operatively)
- Peak Pain Score During First 30 Minutes(0-30 minutes post-operative)
- Peak Pain Score(0-150 minutes post-operative)
- Average Time to Discharge(0-150 minutes post-operative)
- Number of Participants With Post Operative Nausea and Vomiting(0-150 minutes post-operative)