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Completed

NCT Number: NCT02016443

Tizanidine and Pain After Herniorrhaphy

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.

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Key information

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Diskapi Yildirim Beyazit training and research hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tizanidine

Drug

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 names: Sirdalud

Placebo

Drug

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 names: Placebo pill

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

Investigation of the Effectiveness of Tizanidine on Pain After Herniorrhaphy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 20, 2013
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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