Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

Not Applicable

• Conditions: Benign Tumor of Thyroid; Hyperparathyroidism
• Interventions: Procedure: Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml); Drug: Dexmedetomidine plus propofol infusion; Procedure: Local infiltraion analgesia; Procedure: General anesthesia with endotracheal tube

• Registration Number: NCT04051099
• Lead Sponsor: Mahidol University

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-21
• Last Update Posted: 2021-05-24
• Primary Completion: 2021-09-30
• Study Completion: 2021-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bilateral cervical plexus block	Local infiltraion analgesia	bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
bilateral cervical plexus block	Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)	bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
bilateral cervical plexus block	Dexmedetomidine plus propofol infusion	bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
General anesthesia	Dexmedetomidine plus propofol infusion	General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
General anesthesia	Local infiltraion analgesia	General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
General anesthesia	General anesthesia with endotracheal tube	General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)

Primary Outcome Measures

Name	Time	Method
Postoperative pain score at rest	24 hours at ward	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok Noi, Bangkok, Thailand