Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

NCT ID: NCT04051099

Last Updated: 2021-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2021-12-15

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).

Conditions

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Benign Tumor of Thyroid Hyperparathyroidism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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bilateral cervical plexus block

bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

bilateral superficial cervical plexus

Dexmedetomidine plus propofol infusion

Intervention Type DRUG

Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion

Local infiltraion analgesia

Intervention Type PROCEDURE

local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml

General anesthesia

General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)

Group Type EXPERIMENTAL

Dexmedetomidine plus propofol infusion

Intervention Type DRUG

Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion

Local infiltraion analgesia

Intervention Type PROCEDURE

local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml

General anesthesia with endotracheal tube

Intervention Type PROCEDURE

Induction with Propofol and intubation with cisatracurium

Interventions

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

bilateral superficial cervical plexus

Intervention Type PROCEDURE

Dexmedetomidine plus propofol infusion

Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion

Intervention Type DRUG

Local infiltraion analgesia

local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml

Intervention Type PROCEDURE

General anesthesia with endotracheal tube

Induction with Propofol and intubation with cisatracurium

Intervention Type PROCEDURE

Other Intervention Names

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BSCPB Conscious sedation LIA GA with ETT

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Suwimon Tangwiwat

Assistant professor, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suwimon Tangwiwat, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Suwimon Tangwiwat, MD

Role: CONTACT

+66816456167

Facility Contacts

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Suwimon Tangwiwat, M.D

Role: primary

(66)81-645-6167

References

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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.

Reference Type BACKGROUND
PMID: 27687375 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25670918 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19571762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22971490 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20037182 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16125070 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 2774445 (View on PubMed)

Other Identifiers

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Si 116/2018

Identifier Type: -

Identifier Source: org_study_id

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