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Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy (PTUSGSCB)

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ClinicalTrials.gov Identifier: NCT02725359
Recruitment Status : Completed
First Posted : April 1, 2016
Last Update Posted : December 20, 2016
Sponsor:
Information provided by (Responsible Party):
Ali Ahiskalioglu, Ataturk University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Thyroidectomy Drug: Placebo Drug: Tizanidine Drug: Bupivacaine Drug: Saline Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Preemptive Single Dose Tizanidine and Ultrasound Guided Superficial Cervical Block on Pain After Thyroidectomy
Study Start Date : April 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Group Placebo (Group P) will receive placebo 1 hour before surgery and bilateral superficial cervical block with saline 10 ml each side
 Drug: Placebo
Group Placebo: will receive a placebo pill 1 hour before surgery
Other Name: Placebo pill

Drug: Saline
USG guided SCPB with saline bilaterally 10 ml each side
Other Name: Saline block
Experimental: Tizanidine
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
Group T: 6 mg tizanidine1 hour before surgery
Other Name: Sirdalud MR

Drug: Bupivacaine
Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side
Active Comparator: Bupivacaine
Group Bupivacaine will receive placebo 1 hour before surgery and bilateral superficial cervical block with %0.25 bupivacaine 10ml each side
 Drug: Placebo
Group Placebo: will receive a placebo pill 1 hour before surgery
Other Name: Placebo pill

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Opioid consumption [ Time Frame: First 24 hours total opioid consumption ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02725359


Locations
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Turkey
Ataturk University
Yakutiye, Erzurum, Turkey, 25100
Sponsors and Collaborators
Ataturk University
Investigators
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Principal Investigator: Ali Ahiskalioglu, Ass.Prof. Ataturk University Anesthesiology and Reanimation
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ali Ahiskalioglu, MD, Ataturk University
ClinicalTrials.gov Identifier: NCT02725359    
Other Study ID Numbers: AUTF ANESTHESIA
First Posted: April 1, 2016    Key Record Dates
Last Update Posted: December 20, 2016
Last Verified: December 2016
Keywords provided by Ali Ahiskalioglu, Ataturk University:
Thyroidectomy pain
Tizanidine
Postoperative analgesia
Ultrasound guided Superficial cervical plexus block
Additional relevant MeSH terms:
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Tizanidine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Anticonvulsants
 Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action