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Completed

NCT Number: NCT01812044

Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

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.

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Key information

Conditions

Strabismus Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Peak Pain Score

    Time frame: 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.

  2. Total Narcotic Use During Post-operative Recovery

    Time frame: Total time in post-operative recovery - up to 6 hours

    This secondary outcome will include total narcotic use

  3. Negative Postoperative Behavior Score on the PHBQ (Post Hospitalization Behavioral Questionnaire)

    Time frame: 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

  4. Average Time to Discharge

    Time frame: 0-150 minutes post-operative

  5. Number of Participants With Post Operative Nausea and Vomiting

    Time frame: 0-150 minutes post-operative

  6. Number of Participants Who Required Anti-emetic Medication Post-operatively

    Time frame: Total time in post-operative recovery - up to 6 hours

  7. Peak Pain Score During First 30 Minutes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
First posted
Mar 15, 2013
Registry last updated
Apr 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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