Assessment and Prevention of Acute Post-herniotomy Pain

Study Overview
=================
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.

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

Conditions
-----------------
Hernia

Intervention / Treatment
-----------------
* Drug: Ketorolac postoperative
* Drug: postoperative Patrol
* Drug: intraoperative analgesia
* Drug: intraoperative analgesia


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ketorolac<br>Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then Ketorolac postoperative 10mg 1cp x 3/die, from the day of surgery for 4 days after surgery. | Drug: Ketorolac postoperative<br>* Ketorolac 10mg 1cp x 3/die<br>* Other names: Toradol;Drug: intraoperative analgesia<br>* ketorolac 30 mg iv<br>* Other names: Ketorolac;Drug: intraoperative analgesia<br>* Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg<br>* Other names: Tramadol;|
| Other: acetaminophene+tramadol<br>Patients will be given intraoperative analgesia with Ketorolac and tramadol before the the end of surgery, then postoperative Patrol (acetaminophene 325mg+tramadol 37,5mg) 1cp x 3/die for 4 days after surgery. | Drug: postoperative Patrol<br>* acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die<br>* Other names: Patrol;Drug: intraoperative analgesia<br>* ketorolac 30 mg iv<br>* Other names: Ketorolac;Drug: intraoperative analgesia<br>* Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg<br>* Other names: Tramadol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 days postherniotomy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 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. | 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. | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Herniotomy