NCT04051099

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3.6 years

First QC Date

March 27, 2018

Last Update Submit

May 21, 2021

Conditions

Benign Tumor of ThyroidHyperparathyroidism

Keywords

bilateral superficial cervical plexus blockthyroid surgeryparathyroid surgery

Outcome Measures

Primary Outcomes (6)

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    0 hour at PACU ( time PACU arrival)

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    1 hours at PACU

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    6 hours at ward

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    12 hours at ward

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    18 hours at ward

  • Postoperative pain score at rest

    Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

    24 hours at ward

Secondary Outcomes (5)

  • Postoperative pain score on swallow

    1 hour PACU

  • Postoperative pain score on swallow

    average NRS at ward at 24 hours

  • Postoperative morphine consumption

    Cumulative dose within 24 hours

  • Complications

    within 24 hours

  • Patient's satisfaction scale score

    at 24 hours

Other Outcomes (1)

  • Conversion rate from RA to GA

    intraoperation

Study Arms (2)

bilateral cervical plexus block

EXPERIMENTAL

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 infusionProcedure: Local infiltraion analgesia

General anesthesia

EXPERIMENTAL

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

Drug: Dexmedetomidine plus propofol infusionProcedure: Local infiltraion analgesiaProcedure: General anesthesia with endotracheal tube

Interventions

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

bilateral superficial cervical plexus

Also known as: BSCPB
bilateral cervical plexus block
Dexmedetomidine plus propofol infusionDRUG

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

Also known as: Conscious sedation
General anesthesiabilateral cervical plexus block
Local infiltraion analgesiaPROCEDURE

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

Also known as: LIA
General anesthesiabilateral cervical plexus block
General anesthesia with endotracheal tubePROCEDURE

Induction with Propofol and intubation with cisatracurium

Also known as: GA with ETT
General anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) grade I-III, aged over 18 years
  • Elective thyroidectomy, thyroid lobectomy, parathyroidectomy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Related Publications (7)

  • 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.

    PMID: 27687375BACKGROUND

  • 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.

    PMID: 25670918BACKGROUND

  • 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.

    PMID: 19571762BACKGROUND

  • 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.

    PMID: 22971490BACKGROUND

  • 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.

    PMID: 20037182BACKGROUND

  • 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.

    PMID: 16125070BACKGROUND

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

    PMID: 2774445BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism

Interventions

BupivacaineDexmedetomidineConscious SedationAnesthesia, General

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnesthesia and AnalgesiaAnesthesia

Study Officials

  • Suwimon Tangwiwat, MD

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suwimon Tangwiwat, MD

CONTACT

+66816456167stangwiwat@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor, Department of Anesthesiology

Study Record Dates

First Submitted

March 27, 2018

First Posted

August 9, 2019

Study Start

March 1, 2018

Primary Completion

September 30, 2021

Study Completion

December 15, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)