Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

Hyperparathyroidism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04051099
• Other study ID #: Si 116/2018
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 15, 2021

Study information

• Verified date: May 2021
• Source: Mahidol University
• Contact: Suwimon Tangwiwat, MD
• Phone: +66816456167
• Email: stangwiwat[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 15, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Tumor of Thyroid
• Hyperparathyroidism
• Thyroid Diseases

Intervention

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

Drug:
• Dexmedetomidine plus propofol infusion
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion

Procedure:
• Local infiltraion analgesia
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
• General anesthesia with endotracheal tube
Induction with Propofol and intubation with cisatracurium

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View Citation

Ueshima H, Hara E, Hiroshi O. 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. — View 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;15:4. doi: 10.1186/1471-2253-15-4. eCollection 2015. — View Citation

Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Conversion rate from RA to GA	Inable operation due to pain or movement, need to convert from RA toGA	intraoperation
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	0 hour at PACU ( time PACU arrival)
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	1 hours at PACU
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	6 hours at ward
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	12 hours at ward
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	18 hours at ward
Primary	Postoperative pain score at rest	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	24 hours at ward
Secondary	Postoperative pain score on swallow	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	1 hour PACU
Secondary	Postoperative pain score on swallow	Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)	average NRS at ward at 24 hours
Secondary	Postoperative morphine consumption	in milligram	Cumulative dose within 24 hours
Secondary	Complications	Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity	within 24 hours
Secondary	Patient's satisfaction scale score	satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)	at 24 hours