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NCT Number: NCT02725359

Tizanidine and 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.

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.

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Key information

Conditions

Thyroidectomy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ataturk University

Yakutiye, Erzurum, 25100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Placebo

Drug

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

Other names: Placebo pill

Tizanidine

Drug

Group T: 6 mg tizanidine1 hour before surgery

Other names: Sirdalud MR

Bupivacaine

Drug

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

Saline

Drug

USG guided SCPB with saline bilaterally 10 ml each side

Other names: Saline block

Primary outcomes

  1. Visual analog pain score

    Time frame: postoperative first hour

    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.

  2. Visual analog pain score

    Time frame: postoperative second hour

    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.

  3. Visual analog pain score

    Time frame: postoperative 4th hour

    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.

  4. Visual analog pain score

    Time frame: postoperative 8th hour

    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.

  5. Visual analog pain score

    Time frame: postoperative 12th hour

    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.

  6. Visual analog pain score

    Time frame: postoperative 24th hour

    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.

Secondary outcomes

  1. Opioid consumption

    Time frame: First 24 hours total opioid consumption

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Acronym: PTUSGSCB

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2016
Registry last updated
Dec 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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