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AzTrials

Benign Tumor of ThyroidNCT04051099

Bilateral Superficial Cervical Plexus Block in Thyroid/Parathyroid Surgery

A study testing Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml), Dexmedetomidine plus propofol infusion and Local infiltraion analgesia in people with Benign Tumor of Thyroid and Hyperparathyroidism, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Benign Tumor of Thyroid, Hyperparathyroidism
What is being tested?
Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml), Dexmedetomidine plus propofol infusion and Local infiltraion analgesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteThailand
Study dates
1 Mar 2018to 15 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Suwimon Tangwiwat, MD contact

+66816456167

stangwiwat@yahoo.com

Thailand1 site, 1 recruiting

  • Faculty of Medicine Siriraj Hospital, Mahidol University

    Bangkok Noi, Bangkok, 10700

    Suwimon Tangwiwat, M.D, (66)81-645-6167, stangwiwat@yahoo.com

    Recruiting

Other trials in Thailand

About this study

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

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.

Read the 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).

Being tested
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
Keywords
bilateral superficial cervical plexus block, thyroid surgery, parathyroid surgery
Medical subject headings
Hyperparathyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called BSCPB

    bilateral superficial cervical plexus

  • Dexmedetomidine plus propofol infusionDrug

    Also called Conscious sedation

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

  • Local infiltraion analgesiaProcedure or surgery

    Also called LIA

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

  • General anesthesia with endotracheal tubeProcedure or surgery

    Also called GA with ETT

    Induction with Propofol and intubation with cisatracurium

Study groups in NCT04051099
Study groupRoleWhat they receive
bilateral cervical plexus blockExperimentalbilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 0.25% bupivacaine 16 mg)
Receives: Procedure: Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml); Drug: Dexmedetomidine plus propofol infusion; Procedure: Local infiltraion analgesia
General anesthesiaExperimentalGeneral anesthesia with endotracheal intubation under total intravenous anesthesia (TIVA)
Receives: Drug: Dexmedetomidine plus propofol infusion; Procedure: Local infiltraion analgesia; Procedure: General anesthesia with endotracheal tube

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain score at rest

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

    Measured: 0 hour at PACU ( time PACU arrival)

  2. Postoperative pain score at rest

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

    Measured: 1 hours at PACU

  3. Postoperative pain score at rest

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

    Measured: 6 hours at ward

  4. Postoperative pain score at rest

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

    Measured: 12 hours at ward

  5. Postoperative pain score at rest

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

    Measured: 18 hours at ward

  6. Postoperative pain score at rest

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

    Measured: 24 hours at ward

Secondary outcomes (5)

  1. Postoperative pain score on swallow

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

    Measured: 1 hour PACU

  2. Postoperative pain score on swallow

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

    Measured: average NRS at ward at 24 hours

  3. Postoperative morphine consumption

    in milligram

    Measured: Cumulative dose within 24 hours

  4. Complications

    Percentage of patients present with hoarseness, dyspnea, local anaesthetic systemic toxicity

    Measured: within 24 hours

  5. Patient's satisfaction scale score

    satisfaction scale score 0-10 ( 0= highly unsatisfied, 10= highly satisfied)

    Measured: at 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start1 Mar 2018
  3. Primary completion30 Sep 2021 (estimated)
  4. Study completion15 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04051099
Sponsor's protocol ID
Si 116/2018
Status last verified
May 2021
First submitted
27 Mar 2018
Last updated
24 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27687375

  • 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.

    PubMed 25670918

  • 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.

    PubMed 19571762

  • 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.

    PubMed 22971490

  • 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.

    PubMed 20037182

  • 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.

    PubMed 16125070

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

    PubMed 2774445

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml), Dexmedetomidine plus propofol infusion and Local infiltraion analgesia in people with Benign Tumor of Thyroid and Hyperparathyroidism, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Suwimon Tangwiwat, MD (+66816456167, stangwiwat@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain score at rest (time frame: 0 hour at PACU ( time PACU arrival)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04051099, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2021.

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