An interventional study of Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml) and Dexmedetomidine plus propofol infusion in Benign Tumor of Thyroid and Hyperparathyroidism, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-24.
Sponsored by Mahidol University · Not applicable, Interventional, and Treatment
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.
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).
967 studies on the registry are indexed under Thyroid Diseases; 197 are open to participants now.
This study's planned enrollment of 52 is below the median of 60 across 544 interventional studies indexed under Thyroid Diseases.
Browse Thyroid Diseases studies →Mahidol University is the lead sponsor of 731 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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) · Drug: Dexmedetomidine plus propofol infusion · Procedure: Local infiltraion analgesia
General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
Drug: Dexmedetomidine plus propofol infusion · Procedure: Local infiltraion analgesia · Procedure: General anesthesia with endotracheal tube
bilateral superficial cervical plexus
Also known as: BSCPB
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
Also known as: Conscious sedation
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
Also known as: LIA
Induction with Propofol and intubation with cisatracurium
Also known as: GA with ETT
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 0 hour at PACU ( time PACU arrival)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 1 hours at PACU
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 6 hours at ward
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 12 hours at ward
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 18 hours at ward
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 24 hours at ward
Postoperative pain score on swallow
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: 1 hour PACU
Postoperative pain score on swallow
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time frame: average NRS at ward at 24 hours
Postoperative morphine consumption
in milligram
Time frame: Cumulative dose within 24 hours
Complications
Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity
Time frame: within 24 hours
Patient's satisfaction scale score
satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)
Time frame: at 24 hours
Conversion rate from RA to GA
Inable operation due to pain or movement, need to convert from RA toGA
Time frame: intraoperation
Plan to share: No
This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Mahidol University