Assessment and Prevention of Acute Post-herniotomy Pain (PTSM04APHP)

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia
• Intervention / Treatment: Drug: Ketorolac postoperative; Drug: intraoperative analgesia; Drug: intraoperative analgesia; Drug: postoperative Patrol

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Lomabardy
    • Pavia, Lomabardy, Italy, 27100
      • IRCCS Policlinico San Matteo
  • Lombardy
    • Varese, Lombardy, Italy, 21100
      • Ospedale di Circolo e Fondazione Macchi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ketorolac; 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; Ketorolac 10mg 1cp x 3/die; Other Names: Toradol; Drug: intraoperative analgesia; ketorolac 30 mg iv; Other Names: Ketorolac; Drug: intraoperative analgesia; Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg; Other Names: Tramadol
Other: acetaminophene+tramadol; 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: intraoperative analgesia; ketorolac 30 mg iv; Other Names: Ketorolac; Drug: intraoperative analgesia; Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg; Other Names: Tramadol; Drug: postoperative Patrol; acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die; Other Names: Patrol

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

Collaborators and Investigators

• Sponsor: IRCCS Policlinico S. Matteo
• Collaborators: University of Pavia
• Investigators: Principal Investigator: Fabrizio Cavalloro, MD, IRCCS Policlinico San Matteo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: April 19, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): June 9, 2014
• Last Update Submitted That Met QC Criteria: May 21, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Herniotomy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ketorolac; Tramadol; Ketorolac Tromethamine
• Other Study ID Numbers: 2009-011856-23