Clinical trial NCT02725359: Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy
Official title: Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thyroidectomy
Keywords: Thyroidectomy pain
Tizanidine
Postoperative analgesia
Ultrasound guided Superficial cervical plexus block
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first hour
measure: Visual analog pain score
timeFrame: postoperative second hour
measure: Visual analog pain score
timeFrame: postoperative 4th hour
measure: Visual analog pain score
timeFrame: postoperative 8th hour
measure: Visual analog pain score
timeFrame: postoperative 12th hour
measure: Visual analog pain score
timeFrame: postoperative 24th hour
Secondary outcomes:
measure: Opioid consumption
timeFrame: First 24 hours total opioid consumption
Other outcomes:
Locations:
city: Yakutiye
country: Turkey
facility: Ataturk University
state: Erzurum
Study officials:
affiliation: Ataturk University Anesthesiology and Reanimation
name: Ali Ahiskalioglu, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.