Parathyroid AdenomaNCT04905641
The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy
An observational study of Parathyroid Adenoma and Thyroid Nodule, run by Mahidol University at 1 site in Thailand.
Trial summary
The aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parathyroid Adenoma, Thyroid Nodule
- What is being tested?
- Bilateral intermediate cervical plexus block
- Type of treatment
- Surgery or procedure
- How many people
- 19 participants
- Where
- 1 siteThailand
- Study dates
- 10 Mar 2016to 31 Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: bilateral intermediate cervical plexus block for thyroid nodule or parathyroid adenoma
Who may be able to join
- patient underwent thyroid/parathyroid surgery under nerve blocks and sedation
Who cannot join
- incomplete opioid consumption or pain score record.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Conditions
- Parathyroid Adenoma, Thyroid Nodule
- Being tested
- Bilateral intermediate cervical plexus block
- Keywords
- intermediate cervical plexus block
- Medical subject headings
- Parathyroid Neoplasms, Thyroid Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral intermediate cervical plexus blockProcedure or surgery
Bilateral intermediate cervical plexus block was performed under ultrasound guidance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Conversion to general anesthesia
inability to operate under nerve block and sedation
Measured: during operation
Secondary outcomes (4)
opioid usage
fentanyl consumption
Measured: intraoperative
dypnea
phrenic nerve paralysis
Measured: intraoperative
pain score within 24 hours
numerical rating score
Measured: within 24 hours postoperative
complications
local anesthetic systemic toxicity
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start10 Mar 2016
- Primary completion25 May 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parathyroid AdenomaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Tangwiwat, Mahidol University
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905641
- Sponsor's protocol ID
- Si 081/2018
- Status last verified
- May 2021
- First submitted
- 26 May 2021
- Last updated
- 1 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 17131394Spanknebel 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.
PubMed 16125070Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10.
PubMed 2774445Plunkett 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.
PubMed 19216305Egan 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.
PubMed 24227357Jung 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.
PubMed 24639923Boussuges 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.
PubMed 19017880
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy Under Moderate Sedation; Retrospective Study
- ClinicalTrials.gov ID
- NCT04905641
- Acronym / sponsor ID
- Si 081/2018
- Conditions
- Parathyroid Adenoma, Thyroid Nodule
- Keywords
- intermediate cervical plexus block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- bilateral intermediate cervical plexus block for thyroid nodule or parathyroid adenoma
Key inclusion criteria (1 listed)
- patient underwent thyroid/parathyroid surgery under nerve blocks and sedation
Key exclusion criteria (1 listed)
- incomplete opioid consumption or pain score record.
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 |
|---|---|---|
| Bilateral intermediate cervical plexus blockBilateral intermediate cervical plexus block was performed under ultrasound guidance. | Procedure or surgery | – |
Primary outcome
Conversion to general anesthesia
Time frame: during operation
inability to operate under nerve block and sedation
4 secondary outcomes
opioid usage
Time frame: intraoperative
dypnea
Time frame: intraoperative
pain score within 24 hours
Time frame: within 24 hours postoperative
complications
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
- Results publication: PubMed 17131394Arora 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.
- Results publication: PubMed 16125070Spanknebel 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.
- Results publication: PubMed 2774445Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10.
- Results publication: PubMed 19216305Plunkett 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.
- Results publication: PubMed 24227357Egan 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.
- Results publication: PubMed 24639923Jung 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.
- Results publication: PubMed 19017880Boussuges 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.
- Individual participant dataSharing planned: No
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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.
Suwimon Tangwiwat, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parathyroid Adenoma and Thyroid Nodule, run by Mahidol University at 1 site in Thailand.
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 1 inclusion and 1 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 1 Jun 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 Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Conversion to general anesthesia (time frame: during operation). 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 NCT04905641, which also lists 7 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 1 Jun 2021.