CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 30 enrolled
Drug / intervention
Tizanidine +1 moredrug
Likely dose
Tizanidine 4 mgfrom record
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Search/NCT02016443
NCT02016443Phase 4Completed

Investigation of the Effectiveness of Tizanidine on Pain After Herniorrhaphy

Diskapi Teaching and Research Hospital·interventional·Posted Dec 20, 2013·Updated Apr 23, 2015

In Brief

A Phase 4 clinical trial evaluating Tizanidine and Placebo for Unilateral Inguinal Hernia. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTurkey (Türkiye)
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 20, 2013
Enrollment StartNov 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.5 years ago

Interventions

Tizanidinedrug

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

Placebodrug

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