Tizanidine and Pain After Herniorrhaphy

NCT02016443 | Completed Phase 4

• 1 other identifier: TIZANIDINE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Inguinal Hernia

Keywords

inguinal hernia

Outcome Measures

Primary Outcomes (4)

• Visual analog pain score

  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.

  postoperative first hour

• Visual analog pain score

  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.

  postoperative 6th hour

• Visual analog pain score

  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.

  Postoperative 12th hour

• Visual analog pain score

  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.

  Postoperative 24th hour

Secondary Outcomes (2)

• Likert score

  Postoperative 1 week

• SF-36 score

  Postoperative first month

Other Outcomes (2)

• hemodynamic parameters

  intraoperative with 5 minutes intervals

• total analgesic consumption

  postoperative 1 week

Study Arms (2)

Tizanidine

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Sirdalud

Tizanidine

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

Also known as: Placebo pill

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist's physiologic state I-III patients undergoing unilateral inguinal herniorrhaphy

You may not qualify if:

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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Yildirim Beyazit training and research hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• Ward A, Brenner M. Guanylate cyclase from Dictyostelium discoideum. Life Sci. 1977 Oct 1;21(7):997-1008. doi: 10.1016/0024-3205(77)90267-3. No abstract available.

  PMID: 22014 BACKGROUND

• Roseboom H, Perrin JH. Oxidation kinetics of phenothiazine and 10-methylphenothiazine in acidic medium. J Pharm Sci. 1977 Oct;66(10):1392-5. doi: 10.1002/jps.2600661010.

  PMID: 21948 BACKGROUND

• Yazicioglu D, Caparlar C, Akkaya T, Mercan U, Kulacoglu H. Tizanidine for the management of acute postoperative pain after inguinal hernia repair: A placebo-controlled double-blind trial. Eur J Anaesthesiol. 2016 Mar;33(3):215-22. doi: 10.1097/EJA.0000000000000371.

  PMID: 26555871 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek Yazicioglu, Dr

  Ministry of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: December 20, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: April 23, 2015

Record last verified: 2013-10

Locations

TU (1)