Benign Tumor of Thyroid, Hyperparathyroidism
Conditions
Keywords
bilateral superficial cervical plexus block, thyroid surgery, parathyroid surgery
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).
Interventions
PROCEDUREBilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)
bilateral superficial cervical plexus
DRUGDexmedetomidine plus propofol infusion
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
PROCEDURELocal infiltraion analgesia
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
Induction with Propofol and intubation with cisatracurium
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at rest | 0 hour at PACU ( time PACU arrival) | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score on swallow | 1 hour PACU | Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable) |
| Postoperative morphine consumption | Cumulative dose within 24 hours | in milligram |
| Complications | within 24 hours | Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity |
| Patient's satisfaction scale score | at 24 hours | satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Conversion rate from RA to GA | intraoperation | Inable operation due to pain or movement, need to convert from RA toGA |
Countries
Thailand
Contacts
Primary ContactSuwimon Tangwiwat, MD
Outcome results
None listed