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Clinical Trials/NCT04051099
NCT04051099
Unknown
Not Applicable

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

Mahidol University1 site in 1 country52 target enrollmentMarch 1, 2018

Overview

Phase
Not Applicable
Intervention
Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)
Conditions
Benign Tumor of Thyroid
Sponsor
Mahidol University
Enrollment
52
Locations
1
Primary Endpoint
Postoperative pain score at rest
Last Updated
4 years ago

Overview

Brief Summary

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.

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
December 15, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Suwimon Tangwiwat

Assistant professor, Department of Anesthesiology

Mahidol University

Eligibility Criteria

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

Arms & Interventions

bilateral cervical plexus block

bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)

Intervention: Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)

bilateral cervical plexus block

bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)

Intervention: Dexmedetomidine plus propofol infusion

bilateral cervical plexus block

bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)

Intervention: Local infiltraion analgesia

General anesthesia

General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)

Intervention: Dexmedetomidine plus propofol infusion

General anesthesia

General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)

Intervention: Local infiltraion analgesia

General anesthesia

General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)

Intervention: General anesthesia with endotracheal tube

Outcomes

Primary Outcomes

Postoperative pain score at rest

Time Frame: 24 hours at ward

Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

Secondary Outcomes

  • Patient's satisfaction scale score(at 24 hours)
  • Postoperative morphine consumption(Cumulative dose within 24 hours)
  • Postoperative pain score on swallow(average NRS at ward at 24 hours)
  • Complications(within 24 hours)

Study Sites (1)

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