NCT01345162

Assessment and Prevention of Acute Post-herniotomy Pain

Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is the assessment and management of Acute Post-herniotomy Pain using two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol.

Detailed description

Persistent post-herniotomy pain (PPP) affects everyday activities in 5-10% of patients. Even brief intervals of acute pain can induce long-term neuronal remodeling and sensitization, chronic pain and lasting psychological distress. Chronic pain may be caused by intense acute PPP, intraoperative nerve injury and/or ongoing inflammation or mesh response with subsequence damage to nerve structures. The aim of our study is to analyze analgesic efficacy, safety and prevention of persistent postsurgical pain of two different pharmacological strategies.

Conditions

• Hernia

Interventions

Type	Name	Description
DRUG	Ketorolac postoperative	Ketorolac 10mg 1cp x 3/die
DRUG	postoperative Patrol	acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
DRUG	intraoperative analgesia	ketorolac 30 mg iv
DRUG	intraoperative analgesia	Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2011-04-29
• Last updated: 2014-06-09
• Results posted: 2014-06-09

Locations

2 sites across 1 country: Italy