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Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02725359
Acronym
PTUSGSCB
Enrollment
60
Registered
2016-04-01
Start date
2016-04-30
Completion date
2016-12-31
Last updated
2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroidectomy

Keywords

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

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.

Interventions

DRUGPlacebo

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

Group T: 6 mg tizanidine1 hour before surgery

DRUGBupivacaine

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

DRUGSaline

USG guided SCPB with saline bilaterally 10 ml each side

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Visual analog pain scorepostoperative first hourPost 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.

Secondary

MeasureTime frame
Opioid consumptionFirst 24 hours total opioid consumption

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026