Tympanomastoid SurgeryPhase 2NCT01638052
Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery
A Phase 2 study testing 0.25% Bupivacaine + Clonidine in people with Tympanomastoid Surgery and Cochlear Implant, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy
- What is being tested?
- 0.25% Bupivacaine + Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Apr 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age 1-18 years
- tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
- ASA I, II
- informed consent and assent obtained
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?
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.
Read the 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
- Being tested
- 0.25% Bupivacaine + Clonidine
- Keywords
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block, Regional Anesthesia
- Medical subject headings
- Cholesteatoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% Bupivacaine + ClonidineDrug
Also called Marcaine
Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
| Study group | Role | What they receive |
|---|---|---|
| 0.25% Bupivacaine | No intervention | This is our standard of care concentration |
| 0.25% Bupivacaine + Clonidine | Experimental | These are not two separate drugs, but a mixture of Bupivacaine and Clonidine. Receives: Drug: 0.25% Bupivacaine + Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 60 minutes
Secondary outcomes (2)
Number of Participants With Nausea/Vomiting
Incidence of nausea/vomiting during 24 hour observation
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startFeb 2006
- Primary completionMar 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tympanomastoid SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Santhanam Suresh, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01638052
- Sponsor's protocol ID
- CMH IRB 2005-12645
- Status last verified
- Jul 2012
- First submitted
- 9 Jul 2012
- Last updated
- 4 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 11916785Wheeler 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.
PubMed 15910348
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Great Auricular Nerve Block for Children Undergoing Tympanomastoid Surgery: Does the Addition of Clonidine Increase the Duration of Postoperative Analgesia?
- ClinicalTrials.gov ID
- NCT01638052
- Acronym / sponsor ID
- CMH IRB 2005-12645
- Conditions
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma
- Keywords
- Tympanomastoid Surgery, Cochlear Implant, Mastoidectomy, Cholesteatoma, Pediatrics, Clonidine, Bupivacaine, Greater Auricular Nerve Block
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Posted 7 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.25% Bupivacaine | No intervention | –This is our standard of care concentration |
| 0.25% Bupivacaine + Clonidine | Experimental | Drug: 0.25% Bupivacaine + ClonidineThese are not two separate drugs, but a mixture of Bupivacaine and Clonidine. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- age 1-18 years
- tympanomastoid surgery (cochlear implant, mastoidectomy, cholesteatoma surgery)
- ASA I, II
- informed consent and assent obtained
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.25% Bupivacaine + ClonidineAlso: MarcainePatients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine | Drug | 0.25% Bupivacaine + Clonidine |
Primary outcome
Average Observer-Rated Patient Pain Scores
Time frame: 60 minutes
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).
2 secondary outcomes
Number of Participants With Nausea/Vomiting
Time frame: 24 hours
Number of Participants Requiring Use of Rescue Analgesic Medication in the Initial 24 Hours Postoperatively
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11916785Suresh 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.
- Background: PubMed 15910348Wheeler 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santhanam Suresh, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 0.25% Bupivacaine + Clonidine in people with Tympanomastoid Surgery and Cochlear Implant, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Observer-Rated Patient Pain Scores (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01638052, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.