StrabismusNCT01812044
Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
A study testing subtenons anesthetic - preservative-free bupivacaine 0.75% and topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel in people with Strabismus, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Strabismus
- What is being tested?
- subtenons anesthetic - preservative-free bupivacaine 0.75% and topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Strabismus
- Being tested
- 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
- Medical subject headings
- Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subtenons anesthetic - preservative-free bupivacaine 0.75%Drug
topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gelDrug
topical control - 0.5 cc of Hypromellose 0.3% gelDrug
subtenons control - 0.5 cc of Normal SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| subtenons anesthetic and topical control | Other | 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 Receives: Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%; Drug: topical control - 0.5 cc of Hypromellose 0.3% gel |
| topical anesthetic and subtenons control | Other | 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 Receives: Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel; Drug: subtenons control - 0.5 cc of Normal Saline |
| topical control and subtenons control | Other | 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 Receives: Drug: topical control - 0.5 cc of Hypromellose 0.3% gel; Drug: subtenons control - 0.5 cc of Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-30 minutes post-operative
Secondary outcomes (7)
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.
Measured: 0-150 minutes post-operative
Total Narcotic Use During Post-operative Recovery
This secondary outcome will include total narcotic use
Measured: Total time in post-operative recovery - up to 6 hours
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
Measured: 1 week (+/- 3 days) post operatively
Average Time to Discharge
Measured: 0-150 minutes post-operative
Number of Participants With Post Operative Nausea and Vomiting
Measured: 0-150 minutes post-operative
Number of Participants Who Required Anti-emetic Medication Post-operatively
Measured: Total time in post-operative recovery - up to 6 hours
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.
Measured: 0-30 minutes post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrabismusStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Enyedi, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01812044
- Sponsor's protocol ID
- Pro00033000
- Status last verified
- Mar 2016
- First submitted
- 13 Mar 2013
- Last updated
- 26 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery
- ClinicalTrials.gov ID
- NCT01812044
- Acronym / sponsor ID
- Pro00033000
- Conditions
- Strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2014 (actual)
- First posted
- 15 Mar 2013 (estimated)
- Results
- Posted 26 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| subtenons anesthetic and topical control | Other | Drug: subtenons anesthetic - preservative-free bupivacaine 0.75%, Drug: topical control - 0.5 cc of Hypromellose 0.3% gelGroup 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 |
| topical anesthetic and subtenons control | Other | Drug: topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel, Drug: subtenons control - 0.5 cc of Normal SalineGroup 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 control and subtenons control | Other | Drug: topical control - 0.5 cc of Hypromellose 0.3% gel, Drug: subtenons control - 0.5 cc of Normal SalineGroup 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 |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subtenons anesthetic - preservative-free bupivacaine 0.75% | Drug | subtenons anesthetic and topical control |
| topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel | Drug | topical anesthetic and subtenons control |
| topical control - 0.5 cc of Hypromellose 0.3% gel | Drug | subtenons anesthetic and topical control, topical control and subtenons control |
| subtenons control - 0.5 cc of Normal Saline | Drug | topical anesthetic and subtenons control, topical control and subtenons control |
Primary outcome
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.
7 secondary outcomes
Peak Pain Score
Time frame: 0-150 minutes post-operative
Total Narcotic Use During Post-operative Recovery
Time frame: Total time in post-operative recovery - up to 6 hours
Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)
Time frame: 1 week (+/- 3 days) post operatively
Average Time to Discharge
Time frame: 0-150 minutes post-operative
Number of Participants With Post Operative Nausea and Vomiting
Time frame: 0-150 minutes post-operative
Number of Participants Who Required Anti-emetic Medication Post-operatively
Time frame: Total time in post-operative recovery - up to 6 hours
Peak Pain Score During First 30 Minutes
Time frame: 0-30 minutes post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Enyedi, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subtenons anesthetic - preservative-free bupivacaine 0.75% and topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel in people with Strabismus, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Pain Score Over the First 30 Post-operative Minutes Using the CHEOPS Scale (time frame: 0-30 minutes post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2016.