Strabismus
Conditions
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.
Interventions
DRUGsubtenons anesthetic - preservative-free bupivacaine 0.75%
DRUGtopical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
DRUGtopical control - 0.5 cc of Hypromellose 0.3% gel
DRUGsubtenons control - 0.5 cc of Normal Saline
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Use During Post-operative Recovery | Total time in post-operative recovery - up to 6 hours | This secondary outcome will include total narcotic use |
| Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | 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 |
| Average Time to Discharge | 0-150 minutes post-operative | — |
| Peak Pain Score | 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. |
| Number of Participants Who Required Anti-emetic Medication Post-operatively | Total time in post-operative recovery - up to 6 hours | — |
| Peak Pain Score During First 30 Minutes | 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. |
| Number of Participants With Post Operative Nausea and Vomiting | 0-150 minutes post-operative | — |
Countries
United States
Participant flow
Recruitment details
57 participants signed consent. 7 participants were withdrawn by PI prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 17 |
| 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 | 16 |
| Total | 50 |
Baseline characteristics
| Characteristic | Subtenons Anesthetic and Topical Control | Topical Anesthetic and Subtenons Control | Topical Control and Subtenons Control | Total |
|---|---|---|---|---|
| Age, Continuous | 53.6 months | 50.1 months | 60.9 months | 54.9 months |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 7 Participants | 21 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 9 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 17 | 0 / 16 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 16 |
Outcome results
Primary
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.
Time frame: 0-30 minutes post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | 6.36 units on a scale | Standard Deviation 0.97 |
| Topical Anesthetic and Subtenons Control | Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | 6.57 units on a scale | Standard Deviation 1.06 |
| Topical Control and Subtenons Control | Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale | 6.58 units on a scale | Standard Deviation 0.51 |
Secondary
Average Time to Discharge
Time frame: 0-150 minutes post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Average Time to Discharge | 106 minutes | Standard Deviation 16 |
| Topical Anesthetic and Subtenons Control | Average Time to Discharge | 107 minutes | Standard Deviation 25 |
| Topical Control and Subtenons Control | Average Time to Discharge | 106 minutes | Standard Deviation 21 |
Secondary
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
Time frame: 1 week (+/- 3 days) post operatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | 80.2 units on a scale | Standard Deviation 7.8 |
| Topical Anesthetic and Subtenons Control | Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | 78.2 units on a scale | Standard Deviation 10.9 |
| Topical Control and Subtenons Control | Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire) | 78.5 units on a scale | Standard Deviation 12.1 |
Secondary
Number of Participants Who Required Anti-emetic Medication Post-operatively
Time frame: Total time in post-operative recovery - up to 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subtenons Anesthetic and Topical Control | Number of Participants Who Required Anti-emetic Medication Post-operatively | 1 participants |
| Topical Anesthetic and Subtenons Control | Number of Participants Who Required Anti-emetic Medication Post-operatively | 1 participants |
| Topical Control and Subtenons Control | Number of Participants Who Required Anti-emetic Medication Post-operatively | 1 participants |
Secondary
Number of Participants With Post Operative Nausea and Vomiting
Time frame: 0-150 minutes post-operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subtenons Anesthetic and Topical Control | Number of Participants With Post Operative Nausea and Vomiting | 1 participants |
| Topical Anesthetic and Subtenons Control | Number of Participants With Post Operative Nausea and Vomiting | 1 participants |
| Topical Control and Subtenons Control | Number of Participants With Post Operative Nausea and Vomiting | 1 participants |
Secondary
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.
Time frame: 0-150 minutes post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Peak Pain Score | 8.65 units on a scale | Standard Deviation 2.42 |
| Topical Anesthetic and Subtenons Control | Peak Pain Score | 10.47 units on a scale | Standard Deviation 2.27 |
| Topical Control and Subtenons Control | Peak Pain Score | 9.69 units on a scale | Standard Deviation 2.15 |
p-value: 0.035Wilcoxon (Mann-Whitney)
p-value: 0.189Wilcoxon (Mann-Whitney)
p-value: 0.298Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: 0-30 minutes post-operative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Peak Pain Score During First 30 Minutes | 7.0 units on a scale | Standard Deviation 1.9 |
| Topical Anesthetic and Subtenons Control | Peak Pain Score During First 30 Minutes | 7.8 units on a scale | Standard Deviation 2.4 |
| Topical Control and Subtenons Control | Peak Pain Score During First 30 Minutes | 8.3 units on a scale | Standard Deviation 2.7 |
Secondary
Total Narcotic Use During Post-operative Recovery
This secondary outcome will include total narcotic use
Time frame: Total time in post-operative recovery - up to 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subtenons Anesthetic and Topical Control | Total Narcotic Use During Post-operative Recovery | 1.65 mcg/kg | Standard Deviation 0.61 |
| Topical Anesthetic and Subtenons Control | Total Narcotic Use During Post-operative Recovery | 1.78 mcg/kg | Standard Deviation 0.66 |
| Topical Control and Subtenons Control | Total Narcotic Use During Post-operative Recovery | 1.60 mcg/kg | Standard Deviation 0.077 |