Investigation of the Effectiveness of Tizanidine on Pain After Herniorrhaphy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analog pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologist's physiologic state I-III patients undergoing unilateral inguinal herniorrhaphy
排除标准
- •chronic pain
- •bleeding disorders
- •renal or hepatic insufficiency
- •patients on chronic non-steroidal anti-inflammatory medications
- •recurrent hernias
- •emergency cases
研究组 & 干预措施
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
干预措施: Tizanidine (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
Visual analog pain score
时间窗: 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.
次要结局
- Likert score(Postoperative 1 week)
- SF-36 score(Postoperative first month)
研究者
DILEK YAZICIOGLU
Principal investigator
Diskapi Teaching and Research Hospital
