Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Duke University
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01812044
First received: March 13, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Strabismus
Drug: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Postoperative Subtenons Anesthesia for Postoperative Pain in Pediatric Strabismus Surgery

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Average pain score over the first 30 post-operative minutes using the CHEOPS scale [ Time Frame: 0-30 minutes post-operative ] [ Designated as safety issue: No ]
    Pain will be assessed by a masked observer using the Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scale. Pain is rated every 5 minutes for the first 30 minutes postoperatively.


Secondary Outcome Measures:
  • Peak pain score in the first 30 minutes [ Time Frame: 0-30 minutes post-operative ] [ Designated as safety issue: No ]
    This secondary outcome will include the peak pain score in the first 30 minutes. Pain will be assessed by masked observers, using the CHEOPS scale. Pain is rated every 5 minutes for the first 30 minutes postoperatively.

  • Total narcotic and anti-emetic use during post-operative recovery [ Time Frame: Total time in post-operative recovery - up to 6 hours ] [ Designated as safety issue: No ]
    This secondary outcome will include total narcotic use, total anti-emetic use, and nausea or vomiting gathered from the anesthesia report from the Anesthesiologist.

  • Negative postoperative behavior score on the PHBQ (post hospitalization behavioral questionnaire) [ Time Frame: 1 week (+/- 3 days) post operatively ] [ Designated as safety issue: No ]
    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.

  • Change in pain score [ Time Frame: 30 minutes post-operative to discharge home ] [ Designated as safety issue: No ]

    Pain scores after 30 minutes will be measured. Pain will be assessed by masked observers, using the CHEOPS scale. Pain is rated:

    • every 15 minutes for the next hour
    • if applicable, hourly until discharge home


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned 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
Drug: subtenons anesthetic - preservative-free bupivacaine 0.75% Drug: 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
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
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
Drug: topical control - 0.5 cc of Hypromellose 0.3% gel Drug: subtenons control - 0.5 cc of Normal Saline

  Eligibility

Ages Eligible for Study:   1 Year to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812044

Contacts
Contact: Laura Enyedi, MD 919-684-2038 laura.enyedi@duke.edu

Locations
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Laura Enyedi, MD    919-684-2038    laura.enyedi@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Laura Enyedi, MD Duke Eye Center
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01812044     History of Changes
Other Study ID Numbers: Pro00033000
Study First Received: March 13, 2013
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Strabismus
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Bupivacaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014