Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

Thyroidectomy Clinical Trial

— PTUSGSCB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725359
• Other study ID #: AUTF ANESTHESIA
• Status: Completed
• Phase: Phase 4
• First received: March 21, 2016
• Last updated: December 19, 2016
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroidectomy

Intervention

Drug:
• Placebo
Group Placebo: will receive a placebo pill 1 hour before surgery
• Tizanidine
Group T: 6 mg tizanidine1 hour before surgery
• Bupivacaine
Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side
• Saline
USG guided SCPB with saline bilaterally 10 ml each side

Locations

Country	Name	City	State
Turkey	Ataturk University	Yakutiye	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gürkan 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. — View 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. — View Citation

Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulaçoglu 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Opioid consumption		First 24 hours total opioid consumption	Yes