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Tizanidine and Pain After Herniorrhaphy

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ClinicalTrials.gov Identifier: NCT02016443
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital

Brief Summary:

Herniorrhaphy is the most frequent general surgical procedure. There are moderate pain complaints after herniorrhaphy. Besides causing discomfort to the patients, pain, can delay recovery and discharge and cause cognitive dysfunction and difficulty with returning to normal daily activity.

A combination of analgesics with different effect sites can reduce the doses needed and analgesic related side effects which is called multimodal analgesia .

Opioids, acetaminophen, nonsteroid anti-inflammatory drugs and cox-2 inhibitors, alfa-2 receptor agonists, steroids, gabapentin and pregabalin have been used for this purpose(4).

Tizanidine is an alfa-2 receptor agonist, and is used for musculoskeletal pain conditions. Tizanidine reduced the local anesthetic requirement in spinal anesthesia.

The aim of this study is to investigate the hypothesis that: Tizanidine can reduce the pain scores, analgesic consumption, analgesic related side effects and provide early return to normal daily activity compared to placebo after inguinal herniorrhaphy.


Condition or disease Intervention/treatment Phase
Unilateral Inguinal Hernia Drug: Tizanidine Drug: Placebo Phase 4

Detailed Description:

Age, body mass index (BMI), concomitant diseases, and the ASA physiologic state will be recorded.

Simple randomization will be accomplished with a computer-generated sequence of numbers and sealed envelopes will be used to allocate patients into 2 groups.

Patients in GroupTizanidine will receive 4 mg tizanidine per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery, patients in Group Placebo will receive the same treatment with a placebo pill concurrently with a standard analgesic treatment: dexketoprofen trometamol; 25 mg intravenous (iv) before the induction of anesthesia and 25 mg per oral 3 times a day-1 week and acetaminophen; 1 g iv at the end of surgery. All patients will be instructed to use acetaminophen 500 mg up to 4 times a day for rescue analgesia and to contact the hospital if they have pain despite all three medications.

Heart rate (HR), peripheral oxygen saturation (SpO2), systolic arterial pressure (SAP), diastolic arterial pressure (DAP) and mean arterial pressure (MAP), end tidal CO2 pressure (EtCO2). Baseline values will recorded.

Anesthesia induction and muscle relaxation will be standardized with 2 mg kg-1 propofol, 0.6 mg kg-1 rocuronium and 50 µg fentanyl. Anesthesia will be maintained with oxygen in nitrous oxide and desflurane. The desflurane concentration will be titrated to keep BIS between 40-60. The patients will receive 50 µg fentanyl boluses in case hemodynamic variables changed ≥30% from baseline values. Hypotension will be defined as ≥20% decrease in MAP from baseline values and will be treated with fluid boluses and/or ephedrine. Bradycardia will be defined as a heart rate <50 beat min and will be treated with atropine. All treatments will be recorded. At the end of surgery volatile anesthesia will be discontinued and the patients will be extubated according to clinical extubation criteria. The time elapsed from discontinuation of volatile anesthesia to eye opening with verbal commands will be recorded as time to emergence. The patients will be transferred to the post anesthesia care unit (PACU). The modified Aldrete score will be used to evaluate recovery in the PACU and the patients will be discharged from the PACU when the Aldrete score is ≥9 ( ). 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 1, 6, 12 and 24 hours postoperatively.

During the control visit 1 week after surgery total analgesic consumption and analgesic related adverse events (nausea, vomiting, dizziness…) will be evaluated. Difficulty with normal daily activity will also be evaluated during this visit with the Likert score (1. no difficulty, 2. mild difficulty, 3. difficulty, 4. severe difficulty, 5. unable to perform daily activity due to pain). Health related quality of life will also be evaluated 1 month after surgery; the Short Form (SF)-36 will be used for this purpose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigation of the Effectiveness of Tizanidine on Pain After Herniorrhaphy
Study Start Date : November 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arm Intervention/treatment
Experimental: Tizanidine
Group Tizanidine (Group T) will receive 4 mg tizanidine per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
Drug: Tizanidine
Group Tizanidine (Group T) will receive 4 mg tizanidine per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
Other Name: Sirdalud

Placebo Comparator: Placebo
Group Placebo (Group P) will receive placebo per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
Drug: Placebo
Group Placebo (Group P) will receive a placebo per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
Other Name: Placebo pill




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 1, 6 and 24 hours postoperatively.

  2. Visual analog pain score [ Time Frame: postoperative 6th 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 1, 6 and 24 hours postoperatively.

  3. 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 1, 6 and 24 hours postoperatively.

  4. 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 1, 6 and 24 hours postoperatively.


Secondary Outcome Measures :
  1. Likert score [ Time Frame: Postoperative 1 week ]
    Difficulty with normal daily activity will be evaluated during the first week control visit with the Likert score (1; no difficulty, 2; mild difficulty, 3; difficulty, 4; severe difficulty, 5; unable to perform daily activity due to pain

  2. SF-36 score [ Time Frame: Postoperative first month ]
    Health related quality of life will be evaluated 6 weeks after surgery; the SF-36 will be used for this purpose


Other Outcome Measures:
  1. hemodynamic parameters [ Time Frame: intraoperative with 5 minutes intervals ]
    systolic, diastolic, mean arterial pressures and heart rate will be measured with 5 minutes intervals

  2. total analgesic consumption [ Time Frame: postoperative 1 week ]
    total analgesic consumption will be determined at postoperative 1 week



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 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 unilateral inguinal herniorrhaphy

Exclusion Criteria:

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

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): NCT02016443


Locations
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Turkey
Diskapi Yildirim Beyazit training and research hospital
Ankara, Turkey
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
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Principal Investigator: Dilek Yazicioglu, Dr Netherlands: Ministry of Health, Welfare and Sports
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DILEK YAZICIOGLU, Principal investigator, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT02016443    
Other Study ID Numbers: TIZANIDINE
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: October 2013
Keywords provided by DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital:
inguinal hernia
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Tizanidine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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