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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 Tolerability

Difference 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

Page last updated: August 23, 2015

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