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ThyroidectomyPhase 4PTUSGSCBNCT02725359

Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

A Phase 4 study testing Tizanidine, Bupivacaine and Saline in people with Thyroidectomy, run by Ataturk University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients. a2-Agonists are sympatholytic and centrally acting antihypertensive agents. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Thyroidectomy
What is being tested?
Tizanidine, Bupivacaine and Saline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
Apr 2016to Dec 2016
Phase
Phase 4
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Society of Anesthesiologist's physiologic state I-III patients undergoing thyroidectomy

Who cannot join

  • chronic pain
  • bleeding disorders
  • renal or hepatic insufficiency
  • patients on chronic non-steroidal anti-inflammatory medications
  • recurrent goiter
  • emergency cases

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ataturk University

    Yakutiye, Erzurum, 25100

Other trials in Turkey (Türkiye)

About this study

Official title: Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy

Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients.

a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions.

Read more

Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. Analgesic effect of US guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has not been reported yet.

The aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores, analgesic consumption, analgesic related side effects.

Conditions
Thyroidectomy
Being tested
Placebo, Tizanidine, Bupivacaine, Saline
Keywords
Thyroidectomy pain, Tizanidine, Postoperative analgesia, Ultrasound guided Superficial cervical plexus block

What participants receive

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

  • PlaceboDrug

    Also called Placebo pill

    Group Placebo: will receive a placebo pill 1 hour before surgery

  • TizanidineDrug

    Also called Sirdalud MR

    Group T: 6 mg tizanidine1 hour before surgery

  • BupivacaineDrug

    Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side

  • SalineDrug

    Also called Saline block

    USG guided SCPB with saline bilaterally 10 ml each side

Study groups in NCT02725359
Study groupRoleWhat they receive
PlaceboPlacebo comparatorGroup Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side
Receives: Drug: Placebo; Drug: Saline
TizanidineExperimentalGroup Tizanidine (Group T) will receive 6 mg tizanidine 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side
Receives: Drug: Tizanidine; Drug: Bupivacaine
BupivacaineActive comparatorGroup Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side
Receives: Drug: Placebo; Drug: Bupivacaine

What is being measured

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

  1. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively.

    Measured: postoperative first hour

  2. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively.

    Measured: postoperative second hour

  3. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively.

    Measured: postoperative 4th hour

  4. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively.

    Measured: postoperative 8th hour

  5. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively.

    Measured: postoperative 12th hour

  6. Visual analog pain score

    Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively.

    Measured: postoperative 24th hour

Secondary outcomes (1)

  1. Opioid consumption

    Measured: First 24 hours total opioid consumption

Timeline

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

  1. First posted1 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionDec 2016
  4. Study completionDec 2016

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02725359
Sponsor's protocol ID
AUTF ANESTHESIA
Acronym
PTUSGSCB
Status last verified
Dec 2016
First submitted
21 Mar 2016
Last updated
20 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.

    PubMed 26555871

  • Talakoub R, Abbasi S, Maghami E, Zavareh SM. The effect of oral tizanidine on postoperative pain relief after elective laparoscopic cholecystectomy. Adv Biomed Res. 2016 Feb 8;5:19. doi: 10.4103/2277-9175.175905. eCollection 2016.

    PubMed 26962521

  • Gurkan Y, Tas Z, Toker K, Solak M. Ultrasound guided bilateral cervical plexus block reduces postoperative opioid consumption following thyroid surgery. J Clin Monit Comput. 2015 Oct;29(5):579-84. doi: 10.1007/s10877-014-9635-x. Epub 2014 Oct 26.

    PubMed 25344881

  • Ahiskalioglu A, Yayik AM, Oral Ahiskalioglu E, Dostbil A, Doymus O, Karadeniz E, Ari MA, Sengoz F, Alici HA, Celik EC. Ultrasound-guided bilateral superficial cervical block and preemptive single-dose oral tizanidine for post-thyroidectomy pain: a randomized-controlled double-blind study. J Anesth. 2018 Apr;32(2):219-226. doi: 10.1007/s00540-018-2468-x. Epub 2018 Feb 21.

    PubMed 29468508

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tizanidine, Bupivacaine and Saline in people with Thyroidectomy, run by Ataturk University at 1 site in Turkey (Türkiye).

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 1 inclusion and 6 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: finished, as of the sponsor's last update on 20 Dec 2016. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog pain score (time frame: postoperative first hour). 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 NCT02725359, which also lists 4 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 20 Dec 2016.

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