The Feasibility of Bilateral Intermediate Cervical Plexus... | NCT04905641

Studies
The Feasibility of Bilateral Intermediate Cervical Plexus Block for Thyroidectomy/Parathyroidectomy

NCT04905641

Sponsor

Mahidol University

Status

Completed

Last Update Posted

Jun 1, 2021Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Parathyroid Adenoma
Thyroid Nodule

Interventions

Bilateral intermediate cervical plexus block

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2016Actual

Primary Completion Date

May 25, 2017Actual

Completion Date

Jul 31, 2017Actual

First Submitted Date

May 26, 2021

First Submission Date that Met QC Criteria

May 26, 2021

First Posted Date

May 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2021

Last Update Posted Date

Jun 1, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bilateral intermediate cervical plexus block	Procedure	Bilateral intermediate cervical plexus block was performed under ultrasound guidance.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Conversion to general anesthesia	inability to operate under nerve block and sedation	during operation

Secondary Outcomes

Measure	Description	Time Frame
opioid usage	fentanyl consumption	intraoperative
dypnea	phrenic nerve paralysis	intraoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient underwent thyroid/parathyroid surgery under nerve blocks and sedation

Exclusion Criteria:

incomplete opioid consumption or pain score record.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

bilateral intermediate cervical plexus block for thyroid nodule or parathyroid adenoma

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suwimon Tangwiwat, MD	Mahidol University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital, Mahidol University		Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17131394	Result	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.
16125070	Result	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.

ID	Term
D010282	Parathyroid Neoplasms
D016606	Thyroid Nodule

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms