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Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

Primary Purpose

Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
0.25% Bupivacaine + Clonidine
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Tympanomastoid Surgery focused on measuring Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block, Regional Anesthesia

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

0.25% Bupivacaine

0.25% Bupivacaine + Clonidine

Arm Description

This is our standard of care concentration

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

Outcomes

Primary Outcome Measures

Average Observer-Rated Patient Pain Scores
Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).

Secondary Outcome Measures

Number of Participants With Nausea/Vomiting
Incidence of nausea/vomiting during 24 hour observation
Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively
Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.

Full Information

First Posted
July 9, 2012
Last Updated
August 2, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01638052
Brief Title
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
Official Title
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma
Keywords
Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block, Regional Anesthesia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.25% Bupivacaine
Arm Type
No Intervention
Arm Description
This is our standard of care concentration
Arm Title
0.25% Bupivacaine + Clonidine
Arm Type
Experimental
Arm Description
These are not two separate drugs, but a mixture of Bupivacaine and Clonidine.
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine + Clonidine
Other Intervention Name(s)
Marcaine
Intervention Description
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
Primary Outcome Measure Information:
Title
Average Observer-Rated Patient Pain Scores
Description
Patients will be observed with behaviors rated at regular time intervals using the CHIPPS (Children and Infants Postoperative Pain Scale) pain survey. The CHIPPS scale values range from a minimum of 0 (no pain, better outcome) to a maximum of 10 (worst pain, worse outcome).
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Number of Participants With Nausea/Vomiting
Description
Incidence of nausea/vomiting during 24 hour observation
Time Frame
24 hours
Title
Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively
Description
Count of participants who will require use of rescue analgesic medication in the initial 24 hours postoperatively as recorded in the hospital or by parents at home following discharge.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santhanam Suresh, MD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11916785
Citation
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.
Results Reference
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PubMed Identifier
15910348
Citation
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.
Results Reference
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Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery

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