Clinical trial NCT04051099: Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery
Official title: Bilateral Superficial Cervical Plexus Block Combined With Intravenous Sedation Versus General Anesthesia in Selected Patients for Thyroid/Parathyroid Surgery ; a Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Benign Tumor of Thyroid
Hyperparathyroidism
Keywords: bilateral superficial cervical plexus block
thyroid surgery
parathyroid surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain score at rest
timeFrame: 0 hour at PACU ( time PACU arrival)
measure: Postoperative pain score at rest
timeFrame: 1 hours at PACU
measure: Postoperative pain score at rest
timeFrame: 6 hours at ward
measure: Postoperative pain score at rest
timeFrame: 12 hours at ward
measure: Postoperative pain score at rest
timeFrame: 18 hours at ward
measure: Postoperative pain score at rest
timeFrame: 24 hours at ward
Secondary outcomes:
measure: Postoperative pain score on swallow
timeFrame: 1 hour PACU
measure: Postoperative pain score on swallow
timeFrame: average NRS at ward at 24 hours
measure: Postoperative morphine consumption
timeFrame: Cumulative dose within 24 hours
measure: Complications
timeFrame: within 24 hours
measure: Patient's satisfaction scale score
timeFrame: at 24 hours
Other outcomes:
measure: Conversion rate from RA to GA
timeFrame: intraoperation
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Suwimon Tangwiwat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ueshima H, Hara E, Hiroshi O. RETRACTED: Successful cases of thyroid surgery performed under only bilateral cervical plexus blocks. J Clin Anesth. 2016 Nov;34:206. doi: 10.1016/j.jclinane.2016.04.014. Epub 2016 May 11. No abstract available.
citation: Wang Q, Li Z, Xu S, Li Y, Zhang X, Liu Q, Xia Y, Papadimos TJ, Xu X. Feasibility of ultrasound-guided capsule-sheath space block combined with anterior cervical cutaneous nerves block for thyroidectomy: an observational pilot study. BMC Anesthesiol. 2015 Jan 19;15(1):4. doi: 10.1186/1471-2253-15-4. eCollection 2015.
citation: Suh YJ, Kim YS, In JH, Joo JD, Jeon YS, Kim HK. Comparison of analgesic efficacy between bilateral superficial and combined (superficial and deep) cervical plexus block administered before thyroid surgery. Eur J Anaesthesiol. 2009 Dec;26(12):1043-7. doi: 10.1097/EJA.0b013e32832d6913.
citation: Cai HD, Lin CZ, Yu CX, Lin XZ. Bilateral superficial cervical plexus block reduces postoperative nausea and vomiting and early postoperative pain after thyroidectomy. J Int Med Res. 2012;40(4):1390-8. doi: 10.1177/147323001204000417.
citation: Ingsathit A, Thakkinstian A, Chaiprasert A, Sangthawan P, Gojaseni P, Kiattisunthorn K, Ongaiyooth L, Vanavanan S, Sirivongs D, Thirakhupt P, Mittal B, Singh AK; Thai-SEEK Group. Prevalence and risk factors of chronic kidney disease in the Thai adult population: Thai SEEK study. Nephrol Dial Transplant. 2010 May;25(5):1567-75. doi: 10.1093/ndt/gfp669. Epub 2009 Dec 27.
citation: Spanknebel K, Chabot JA, DiGiorgi M, Cheung K, Lee S, Allendorf J, Logerfo P. Thyroidectomy using local anesthesia: a report of 1,025 cases over 16 years. J Am Coll Surg. 2005 Sep;201(3):375-85. doi: 10.1016/j.jamcollsurg.2005.04.034.
citation: Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10.