Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

NCT ID: NCT01638052

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-04-30

Brief Summary

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.

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.

Conditions

Tympanomastoid Surgery; Cochlear Implant; Mastoidectomy; Cholesteatoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

0.25% Bupivacaine

This is our standard of care concentration

Group Type: NO_INTERVENTION

No interventions assigned to this group

0.25% Bupivacaine + Clonidine

These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.

Group Type: EXPERIMENTAL

0.25% Bupivacaine + Clonidine

Intervention Type: DRUG

Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Interventions

0.25% Bupivacaine + Clonidine

Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine

Intervention Type: DRUG

Other Intervention Names

Marcaine

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Santhanam Suresh, MD

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Countries

United States

References

Suresh S, Barcelona SL, Young NM, Seligman I, Heffner CL, Cote CJ. Postoperative pain relief in children undergoing tympanomastoid surgery: is a regional block better than opioids? Anesth Analg. 2002 Apr;94(4):859-62, table of contents. doi: 10.1097/00000539-200204000-00015.

Reference Type: BACKGROUND

PMID: 11916785 (View on PubMed)

Wheeler M, Patel A, Suresh S, Roth AG, Birmingham PK, Heffner CL, Cote CJ. The addition of clonidine 2 microg.kg-1 does not enhance the postoperative analgesia of a caudal block using 0.125% bupivacaine and epinephrine 1:200,000 in children: a prospective, double-blind, randomized study. Paediatr Anaesth. 2005 Jun;15(6):476-83. doi: 10.1111/j.1460-9592.2005.01481.x.

Reference Type: BACKGROUND

PMID: 15910348 (View on PubMed)

Other Identifiers

CMH IRB 2005-12645

Identifier Type: -

Identifier Source: org_study_id