Assessment and Prevention of Acute Post-herniotomy Pain

Fondazione IRCCS Policlinico San Matteo di Pavia200 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Hernia

Interventions

Ketorolac postoperativeDRUG

Ketorolac 10mg 1cp x 3/die

postoperative PatrolDRUG

acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die

intraoperative analgesiaDRUG

ketorolac 30 mg iv

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 (2)

IRCCS Policlinico San Matteo

Pavia, Lomabardy, Italy

Ospedale di Circolo e Fondazione Macchi

Varese, Lombardy, Italy

Outcomes

Primary Outcomes

Analgesic Efficacy

percentage of patients with NRS≥4. (NRS=numeric rating scale; o quantify pain from0=no pain to 10=worst pain possible). NRS≥4 is cosidered as suboptimal pain control worth to be treated with adjunctive analgesics. We therefore condidered the difference in percentage of patients experiencing not optimal pain control in the two groups to understand, if any, the difference in analgesic efficacy between the two drugs.

Time frame: 4 days postherniotomy

Secondary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded. Assessment of any difference between the two groups.

Time frame: 4 days postherniotoy

Difference in Recovering Daily Activity

Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)

Time frame: 4 days after surgical procedure

Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications

Assessment of the recurrence of surgical complications. Evaluation of all the patients after 5 days by clinical evaluation. After 1 and 3 month in the patients who refer pain. Assessment of any difference between the two groups.

Time frame: 4 days postherniotomy

Development of Persistent Postoperative Pain

Assessment of pain prevalence and presentation of persistant postoperative pain. Evaluation of all the patients after 1 and 3 months by phone call and with clinical re-evaluation in all patients who referred pain.

Time frame: Up to 3 months

Data from ClinicalTrials.gov

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