- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04905641
The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy
May 27, 2021 updated by: Suwimon Tangwiwat, Mahidol University
The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy Under Moderate Sedation; Retrospective Study
The aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Bilateral intermediate cervical plexus blocks have been reported for thyroid/parathyroid surgery.
This technique combined with intravenous sedation has used with safety in patients undergoing simple thyroid or parathyroid surgery.
Simple surgery is defined as the thyroid conditions are not cancer, redo or substernal goiter.
Study Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bangkok, Thailand, 10700
- Faculty of Medicine Siriraj Hospital, Mahidol University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
bilateral intermediate cervical plexus block for thyroid nodule or parathyroid adenoma
Description
Inclusion Criteria:
- patient underwent thyroid/parathyroid surgery under nerve blocks and sedation
Exclusion Criteria:
- incomplete opioid consumption or pain score record.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion to general anesthesia
Time Frame: during operation
|
inability to operate under nerve block and sedation
|
during operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
opioid usage
Time Frame: intraoperative
|
fentanyl consumption
|
intraoperative
|
dypnea
Time Frame: intraoperative
|
phrenic nerve paralysis
|
intraoperative
|
pain score within 24 hours
Time Frame: within 24 hours postoperative
|
numerical rating score
|
within 24 hours postoperative
|
complications
Time Frame: intraoperative
|
local anesthetic systemic toxicity
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Suwimon Tangwiwat, MD, Mahidol University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Boussuges A, Gole Y, Blanc P. Diaphragmatic motion studied by m-mode ultrasonography: methods, reproducibility, and normal values. Chest. 2009 Feb;135(2):391-400. doi: 10.1378/chest.08-1541. Epub 2008 Nov 18.
- Arora N, Dhar P, Fahey TJ 3rd. Seminars: local and regional anesthesia for thyroid surgery. J Surg Oncol. 2006 Dec 15;94(8):708-13. doi: 10.1002/jso.20694.
- Spanknebel K, Chabot JA, DiGiorgi M, Cheung K, Lee S, Allendorf J, Logerfo P. Thyroidectomy using local anesthesia: a report of 1,025 cases over 16 years. J Am Coll Surg. 2005 Sep;201(3):375-85. doi: 10.1016/j.jamcollsurg.2005.04.034.
- Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10.
- Plunkett AR, Shields C, Stojadinovic A, Buckenmaier CC. Awake thyroidectomy under local anesthesia and dexmedetomidine infusion. Mil Med. 2009 Jan;174(1):100-2. doi: 10.7205/milmed-d-01-2908.
- Egan RJ, Hopkins JC, Beamish AJ, Shah R, Edwards AG, Morgan JD. Randomized clinical trial of intraoperative superficial cervical plexus block versus incisional local anaesthesia in thyroid and parathyroid surgery. Br J Surg. 2013 Dec;100(13):1732-8. doi: 10.1002/bjs.9292.
- Jung KJ, Park JY, Hwang DW, Kim JH, Kim JH. Ultrasonographic diaphragmatic motion analysis and its correlation with pulmonary function in hemiplegic stroke patients. Ann Rehabil Med. 2014 Feb;38(1):29-37. doi: 10.5535/arm.2014.38.1.29. Epub 2014 Feb 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 10, 2016
Primary Completion (Actual)
May 25, 2017
Study Completion (Actual)
July 31, 2017
Study Registration Dates
First Submitted
May 26, 2021
First Submitted That Met QC Criteria
May 26, 2021
First Posted (Actual)
May 27, 2021
Study Record Updates
Last Update Posted (Actual)
June 1, 2021
Last Update Submitted That Met QC Criteria
May 27, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Si 081/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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