Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

May 21, 2021 updated by: Suwimon Tangwiwat, Mahidol University

Bilateral Superficial Cervical Plexus Block Combined With Intravenous Sedation Versus General Anesthesia in Selected Patients for Thyroid/Parathyroid Surgery ; a Prospective Randomized Control Trial

To compare efficacy and safety between bilateral superficial cervical plexus block combined with intravenous sedation (RA group) and general anesthesia (GA group) for thyroid and parathyroid operations. This study evaluates postoperative numerical pain score and systemic opioid requirement within 24 hours.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

According to literature review, there is limit information about efficacy and safety of thyroid and parathyroid operations under bilateral superficial cervical plexus block combined with intravenous sedation without general anesthesia. General anesthesia is commonly used for neck operations because it is easy to perform. However in high cardiovascular or pulmonary risk patients such as end stage renal disease (ESRD) patients, regional anesthesia such as superficial cervical plexus block combined with intravenous sedation have become an alternative technique for neck operations.

This study evaluate whether regional anesthesia (RA) technique can be the alternative technique for thyroid/parathyroid surgery compare to conventional technique (GA).

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital, Mahidol University
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) grade I-III, aged over 18 years
  • Elective thyroidectomy, thyroid lobectomy, parathyroidectomy

Exclusion Criteria:

  • Language barrier or inability to communicate with the operating team
  • Allergy to local anaesthetic
  • Known substernal, retroesophageal or retrotracheal goiter
  • Thyroid cancer
  • Previous neck exploration or neck radiation
  • Recurrent laryngeal nerve paralysis
  • BMI ≥ 30

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bilateral cervical plexus block
bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
Procedure: Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)
bilateral superficial cervical plexus
Other Names:
  • BSCPB
Drug: Dexmedetomidine plus propofol infusion
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
Other Names:
  • Conscious sedation
Procedure: Local infiltraion analgesia
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
Other Names:
  • LIA
Experimental: General anesthesia
General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
Drug: Dexmedetomidine plus propofol infusion
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
Other Names:
  • Conscious sedation
Procedure: Local infiltraion analgesia
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
Other Names:
  • LIA
Procedure: General anesthesia with endotracheal tube
Induction with Propofol and intubation with cisatracurium
Other Names:
  • GA with ETT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score at rest
Time Frame: 0 hour at PACU ( time PACU arrival)
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
0 hour at PACU ( time PACU arrival)
Postoperative pain score at rest
Time Frame: 1 hours at PACU
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
1 hours at PACU
Postoperative pain score at rest
Time Frame: 6 hours at ward
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
6 hours at ward
Postoperative pain score at rest
Time Frame: 12 hours at ward
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
12 hours at ward
Postoperative pain score at rest
Time Frame: 18 hours at ward
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
18 hours at ward
Postoperative pain score at rest
Time Frame: 24 hours at ward
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
24 hours at ward

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score on swallow
Time Frame: 1 hour PACU
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
1 hour PACU
Postoperative pain score on swallow
Time Frame: average NRS at ward at 24 hours
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
average NRS at ward at 24 hours
Postoperative morphine consumption
Time Frame: Cumulative dose within 24 hours
in milligram
Cumulative dose within 24 hours
Complications
Time Frame: within 24 hours
Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity
within 24 hours
Patient's satisfaction scale score
Time Frame: at 24 hours
satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)
at 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate from RA to GA
Time Frame: intraoperation
Inable operation due to pain or movement, need to convert from RA toGA
intraoperation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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 1, 2018

Primary Completion (Anticipated)

September 30, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 116/2018

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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