NCT04905641

Brief Summary

The aim of this study was evaluated the feasibility of bilateral intermediate cervical plexus blockade to be anesthesia for simple thyroid/parathyroid surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

May 26, 2021

Last Update Submit

May 27, 2021

Conditions

Parathyroid AdenomaThyroid Nodule

Keywords

intermediate cervical plexus block

Outcome Measures

Primary Outcomes (1)

  • Conversion to general anesthesia

    inability to operate under nerve block and sedation

    during operation

Secondary Outcomes (4)

  • opioid usage

    intraoperative

  • dypnea

    intraoperative

  • pain score within 24 hours

    within 24 hours postoperative

  • complications

    intraoperative

Interventions

Bilateral intermediate cervical plexus blockPROCEDURE

Bilateral intermediate cervical plexus block was performed under ultrasound guidance.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

bilateral intermediate cervical plexus block for thyroid nodule or parathyroid adenoma

You may qualify if:

  • patient underwent thyroid/parathyroid surgery under nerve blocks and sedation

You may not qualify if:

  • incomplete opioid consumption or pain score record.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, 10700, Thailand

Location

Related 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. doi: 10.1002/jso.20694.

    PMID: 17131394RESULT

  • 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.

    PMID: 16125070RESULT

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

    PMID: 2774445RESULT

  • 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.

    PMID: 19216305RESULT

  • 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.

    PMID: 24227357RESULT

  • 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.

    PMID: 24639923RESULT

  • 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.

    PMID: 19017880RESULT

MeSH Terms

Conditions

Parathyroid NeoplasmsThyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesParathyroid DiseasesThyroid NeoplasmsThyroid Diseases

Study Officials

  • Suwimon Tangwiwat, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

May 26, 2021

First Posted

May 27, 2021

Study Start

March 10, 2016

Primary Completion

May 25, 2017

Study Completion

July 31, 2017

Last Updated

June 1, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)