Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

Mahidol University

Status: Unknown

Conditions: Hyperparathyroidism; Benign Tumor of Thyroid

Treatments: Procedure: General anesthesia with endotracheal tube; Procedure: Local infiltraion analgesia; Drug: Dexmedetomidine plus propofol infusion; Procedure: Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)

Study type: Interventional

Funder types: Other

Identifiers

NCT04051099

Si 116/2018

Details and patient eligibility

About

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.

Full 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).

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

bilateral cervical plexus block

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine plus propofol infusion

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

Procedure: Local infiltraion analgesia

General anesthesia

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine plus propofol infusion

Procedure: Local infiltraion analgesia

Procedure: General anesthesia with endotracheal tube