Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

NCT02725359 | Completed Phase 4

• 1 other identifier: AUTF ANESTHESIA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroidectomy

Keywords

Thyroidectomy pain; Tizanidine; Postoperative analgesia; Ultrasound guided Superficial cervical plexus block

Outcome Measures

Primary Outcomes (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 first hour postoperatively.

  postoperative first hour

• 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.

  postoperative second hour

• 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.

  postoperative 4th hour

• 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.

  postoperative 8th hour

• 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.

  postoperative 12th hour

• 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.

  postoperative 24th hour

Secondary Outcomes (1)

• Opioid consumption

  First 24 hours total opioid consumption

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side

Drug: Placebo; Drug: Saline

Tizanidine

EXPERIMENTAL

Group Tizanidine (Group T) will receive 6 mg tizanidine 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side

Drug: Tizanidine; Drug: Bupivacaine

Bupivacaine

ACTIVE COMPARATOR

Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side

Drug: Placebo; Drug: Bupivacaine

Interventions

Placebo DRUG

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

Also known as: Placebo pill

Bupivacaine; Placebo

Tizanidine DRUG

Group T: 6 mg tizanidine1 hour before surgery

Also known as: Sirdalud MR

Tizanidine

Bupivacaine DRUG

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

Bupivacaine; Tizanidine

Saline DRUG

USG guided SCPB with saline bilaterally 10 ml each side

Also known as: Saline block

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Yakutiye, Erzurum, 25100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 26555871 BACKGROUND

• 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.

  PMID: 26962521 BACKGROUND

• 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.

  PMID: 25344881 BACKGROUND

• 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.

  PMID: 29468508 DERIVED

MeSH Terms

Interventions

tizanidine; Bupivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ali Ahiskalioglu, Ass.Prof.

  Ataturk University Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 1, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Locations

TU (1)