Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Benign Tumor of Thyroid, Hyperparathyroidism

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bilateral cervical plexus block<br>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)<br>* bilateral superficial cervical plexus<br>* Other names: BSCPB;Drug: Dexmedetomidine plus propofol infusion<br>* Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion<br>* Other names: Conscious sedation;Procedure: Local infiltraion analgesia<br>* local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml<br>* Other names: LIA;|
| Experimental: General anesthesia<br>General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA) | Drug: Dexmedetomidine plus propofol infusion<br>* Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion<br>* Other names: Conscious sedation;Procedure: Local infiltraion analgesia<br>* local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml<br>* Other names: LIA;Procedure: General anesthesia with endotracheal tube<br>* Induction with Propofol and intubation with cisatracurium<br>* Other names: GA with ETT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 0 hour at PACU ( time PACU arrival) | 
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 1 hours at PACU | 
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 6 hours at ward | 
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 12 hours at ward | 
| Postoperative pain score at rest | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 18 hours at ward | 
| Postoperative pain score at rest | 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 | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | 1 hour PACU | 
| Postoperative pain score on swallow | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) | average NRS at ward at 24 hours | 
| Postoperative morphine consumption | in milligram | Cumulative dose within 24 hours | 
| Complications | Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity | within 24 hours | 
| Patient's satisfaction scale score | satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied) | at 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bilateral superficial cervical plexus block, thyroid surgery, parathyroid surgery