Great Auricular Nerve Block for Tympanomastoid Surgery: Will the Addition of Clonidine Enhance the Duration of Analgesia?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01638052
First received: July 9, 2012
Last updated: March 19, 2013
Last verified: July 2012
  Purpose

The investigators goal is to determine the efficacy and duration of analgesia with the addition of Clonidine, an alpha-2 agonist, to local anesthetic blockade using bupivacaine, of the great auricular nerve in children undergoing tympanomastoid surgery.


Condition Intervention Phase
Tympanomastoid Surgery
Cochlear Implant
Mastoidectomy
Cholesteatoma
Drug: 0.25% Bupivacaine + Clonidine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Duration of greater auricular nerve block [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Patients will be observed using a CHIPPS (Children and Infants Postoperative Pain Scale) pain survey


Secondary Outcome Measures:
  • Nausea/Vomiting [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Incidence of nausea/vomiting during 24 hour observation

  • Need for rescue analgesic [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Use of rescue analgesic in hospital and by parents at home

  • Hemodynamics [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured pre- and post-block


Enrollment: 56
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 0.25% Bupivacaine
This is our standard of care concentration
Experimental: 0.25% Bupivacaine + Clonidine
These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
Drug: 0.25% Bupivacaine + Clonidine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Detailed Description:

The surgical anesthesia during the operative procedure will be maintained using volatile anesthetics. No prophylactic dexamethasone or ondansetron would be provided to any patients in either group. Anesthesia will be discontinued at the end of the procedure and the patient will be extubated once standard extubation criteria have been met. Patients will be then taken to the postoperative recovery room where they will be evaluated for pain and discomfort by a blinded observer using the CHIPPS (Children and Infants Postoperative Pain Scale). If two consecutive pain scores at 5 minute intervals is >6, they will be rescued with incremental doses of 0.05 mg/kg of intravenous morphine required to reach a score of <6. The number of rescue doses as well as the pain scores will be documented. These patients will be also observed for the presence of nausea/vomiting. Any patient who vomits more than two times will be rescued with ondansetron 0.1 mg/kg intravenously. All patients will be continued to be evaluated in the 23 hour unit. Pain and side effects will be assessed for the next 6 hours or until discharge from the 23 hour observation facility. Standard doses of acetaminophen with codeine will be provided for pain relief in the 23 hour observational unit, as well as on discharge. The number of doses of acetaminophen with codeine will be recorded. Time to discharge from the hospital will also be noted. A questionnaire designed to address parent/patient satisfaction will be utilized and will allude to the need for rescue analgesia and the need for any other additional analgesics provided. The use of any additional rescue pain medication will be provided to the families at the time of discharge. A follow-up phone call will be made in 24 hours to note the information provided on the questionnaire.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 1-18 years
  • tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
  • ASA I, II
  • informed consent and assent obtained

Exclusion Criteria:

  • allergic to local anesthestic
  • taking chronic aspirin or Ibuprofen therapy
  • ASA IV
  • history of clinically important renal, hepatic, respiratory, cardiac, or neurological conditions
  • Patients who have cardiovascular surgery other than an atrial septal defect or a ventricular septal defect, or who have undergone complete corrective intracardiac repair of congenital heart disease.
  • Informed consent not obtained
  • Patients expected to receive dexamethasone or ondansetron intra-operative
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01638052

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

Publications:
Responsible Party: Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01638052     History of Changes
Other Study ID Numbers: CMH IRB 2005-12645
Study First Received: July 9, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Tympanomastoid Surgery
Cochlear Implant
Mastoidectomy
Cholesteatoma
Pediatrics
Clonidine
Bupivacaine
Greater Auricular Nerve Block
Regional Anesthesia

Additional relevant MeSH terms:
Cholesteatoma
Keratosis
Skin Diseases
Bupivacaine
Clonidine
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
Analgesics
Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 20, 2014