Assessment and Prevention of Acute Post-herniotomy Pain
Information source: IRCCS Policlinico S. Matteo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hernia
Intervention: Ketorolac postoperative (Drug); postoperative Patrol (Drug); intraoperative analgesia (Drug); intraoperative analgesia (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: IRCCS Policlinico S. Matteo Official(s) and/or principal investigator(s): Fabrizio Cavalloro, MD, Principal Investigator, Affiliation: IRCCS Policlinico San Matteo
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.
Clinical Details
Official title: Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Analgesic Efficacy
Secondary outcome: Number of Participants With Adverse Events as a Measure of Safety and TolerabilityDifference in Recovering Daily Activity Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications Development of Persistent Postoperative Pain
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Males and females over 18 years, under 80 years, scheduled for elective herniotomy
- Classification American Society of Anesthesiologists (ASA) I: without systemic
disease
- Classification ASA II or III (mild systemic disease or severe systemic disease that
limits the activity without invalidity).
- Patients with hernia typ 2, 3a, 3b (classification NYHUS (1993))
- Signed informed consent
Exclusion Criteria:
- ASA III, IV
- Emergency surgery
- Recovery in intensive care unit after surgery
- habitual opioid consumption
- NSADs allergy
- cognitive or mental alterations
- coagulopathy
- piastrinemia < 100. 000/mm3
Locations and Contacts
IRCCS Policlinico San Matteo, Pavia, Lomabardy 27100, Italy
Ospedale di Circolo e Fondazione Macchi, Varese, Lombardy 21100, Italy
Additional Information
Starting date: March 2010
Last updated: May 21, 2014
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