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Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

Primary Purpose

Benign Tumor of Thyroid, Hyperparathyroidism

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)
Dexmedetomidine plus propofol infusion
Local infiltraion analgesia
General anesthesia with endotracheal tube
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Tumor of Thyroid focused on measuring bilateral superficial cervical plexus block, thyroid surgery, parathyroid surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bilateral cervical plexus block

General anesthesia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score at rest
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)

Secondary Outcome Measures

Postoperative pain score on swallow
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative pain score on swallow
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Postoperative morphine consumption
in milligram
Complications
Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity
Patient's satisfaction scale score
satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)

Full Information

First Posted
March 27, 2018
Last Updated
May 21, 2021
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04051099
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 30, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Tumor of Thyroid, Hyperparathyroidism
Keywords
bilateral superficial cervical plexus block, thyroid surgery, parathyroid surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bilateral cervical plexus block
Arm Type
Experimental
Arm Description
bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
Arm Title
General anesthesia
Arm Type
Experimental
Arm Description
General anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
Intervention Type
Procedure
Intervention Name(s)
Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)
Other Intervention Name(s)
BSCPB
Intervention Description
bilateral superficial cervical plexus
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine plus propofol infusion
Other Intervention Name(s)
Conscious sedation
Intervention Description
Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
Intervention Type
Procedure
Intervention Name(s)
Local infiltraion analgesia
Other Intervention Name(s)
LIA
Intervention Description
local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
Intervention Type
Procedure
Intervention Name(s)
General anesthesia with endotracheal tube
Other Intervention Name(s)
GA with ETT
Intervention Description
Induction with Propofol and intubation with cisatracurium
Primary Outcome Measure Information:
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
0 hour at PACU ( time PACU arrival)
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
1 hours at PACU
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
6 hours at ward
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
12 hours at ward
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
18 hours at ward
Title
Postoperative pain score at rest
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
24 hours at ward
Secondary Outcome Measure Information:
Title
Postoperative pain score on swallow
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
1 hour PACU
Title
Postoperative pain score on swallow
Description
Numerical rating scale 0-10 (0=no pain, 10= worst pain imaginable)
Time Frame
average NRS at ward at 24 hours
Title
Postoperative morphine consumption
Description
in milligram
Time Frame
Cumulative dose within 24 hours
Title
Complications
Description
Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity
Time Frame
within 24 hours
Title
Patient's satisfaction scale score
Description
satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)
Time Frame
at 24 hours
Other Pre-specified Outcome Measures:
Title
Conversion rate from RA to GA
Description
Inable operation due to pain or movement, need to convert from RA toGA
Time Frame
intraoperation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suwimon Tangwiwat, MD
Phone
+66816456167
Email
stangwiwat@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, M.D
Phone
(66)81-645-6167
Email
stangwiwat@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27687375
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.
Results Reference
background
PubMed Identifier
25670918
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.
Results Reference
background
PubMed Identifier
19571762
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.
Results Reference
background
PubMed Identifier
22971490
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.
Results Reference
background
PubMed Identifier
20037182
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.
Results Reference
background
PubMed Identifier
16125070
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.
Results Reference
background
PubMed Identifier
2774445
Citation
Yerzingatsian KL. Thyroidectomy under local analgesia: the anatomical basis of cervical blocks. Ann R Coll Surg Engl. 1989 Jul;71(4):207-10.
Results Reference
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Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

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