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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04905641
Other study ID # Si 081/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2016
Est. completion date July 31, 2017

Study information

Verified date May 2021
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date July 31, 2017
Est. primary completion date May 25, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patient underwent thyroid/parathyroid surgery under nerve blocks and sedation Exclusion Criteria: - incomplete opioid consumption or pain score record.

Study Design


Intervention

Procedure:
Bilateral intermediate cervical plexus block
Bilateral intermediate cervical plexus block was performed under ultrasound guidance.

Locations

Country Name City State
Thailand Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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: — View Citation

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. — View Citation

Plunkett AR, Shields C, Stojadinovic A, Buckenmaier CC. Awake thyroidectomy under local anesthesia and dexmedetomidine infusion. Mil Med. 2009 Jan;174(1):100-2. — View Citation

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. — View Citation

Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Conversion to general anesthesia inability to operate under nerve block and sedation during operation
Secondary opioid usage fentanyl consumption intraoperative
Secondary dypnea phrenic nerve paralysis intraoperative
Secondary pain score within 24 hours numerical rating score within 24 hours postoperative
Secondary complications local anesthetic systemic toxicity intraoperative
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