Clinical trial NCT01345162: Assessment and Prevention of Acute Post-herniotomy Pain
Official title: Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hernia
Keywords: Herniotomy
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
Collaborators: name: University of Pavia
First posted: 2011-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Analgesic Efficacy
timeFrame: 4 days postherniotomy
Secondary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: 4 days postherniotoy
measure: Difference in Recovering Daily Activity
timeFrame: 4 days after surgical procedure
measure: Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications
timeFrame: 4 days postherniotomy
measure: Development of Persistent Postoperative Pain
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Policlinico San Matteo
state: Lomabardy
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi
state: Lombardy
Study officials:
affiliation: IRCCS Policlinico San Matteo
name: Fabrizio Cavalloro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bugada D, Lavand'homme P, Ambrosoli AL, Klersy C, Braschi A, Fanelli G, Saccani Jotti GM, Allegri M; SIMPAR group. Effect of postoperative analgesia on acute and persistent postherniotomy pain: a randomized study. J Clin Anesth. 2015 Dec;27(8):658-64. doi: 10.1016/j.jclinane.2015.06.008. Epub 2015 Aug 30.