Assessment and Prevention of Acute Post-herniotomy Pain (PTSM04APHP)
This study is currently recruiting participants.
Verified January 2012 by IRCCS Policlinico S. Matteo
Sponsor:
IRCCS Policlinico S. Matteo
Collaborator:
University of Pavia
Information provided by (Responsible Party):
Massimo Allegri, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier:
NCT01345162
First received: April 19, 2011
Last updated: January 19, 2012
Last verified: January 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hernia |
Drug: postoperative analgesic treatment |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized, Prospective Study of the Assessment, Prevention and Management of Acute Post-herniotomy Pain |
Resource links provided by NLM:
Further study details as provided by IRCCS Policlinico S. Matteo:
Primary Outcome Measures:
- Assessment of the acute post-herniotomy pain during the treatment with two different therapeutical protocols per os: ketorolac versus association of acetaminophene+tramadol [ Time Frame: 4 days postheriotomy ] [ Designated as safety issue: No ]Difference of pain control (1 episode of NRS>4)between the to groups (ketorolac versus association of acetaminophene+tramadol), in terms of percentages, while pain (according to the Numeric Rate Scale-NRS) is recorded twice daily in a pain diary for 5 days.
Secondary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 4 days postherniotoy ] [ Designated as safety issue: Yes ]
All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.
Assessment of any difference between the two groups.
- Difference in recovering daily activity [ Time Frame: 4 days after surgical procedure ] [ Designated as safety issue: No ]Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)
- Assessment of any connections between the two therapeutical strategies and the recurrence of surgical complications [ Time Frame: 4 days postherniotomy ] [ Designated as safety issue: Yes ]
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.
- Development of persistent postoperative pain [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
ketorolac
Ketorolac 10mg 1cp x 3/die |
Drug: postoperative analgesic treatment
Other Names:
|
|
acetaminophene + tramadol
acetaminophene 325mg+tramadol 37,5mg 1cp x 3/die |
Drug: postoperative analgesic treatment
Other Names:
|
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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345162
Contacts
| Contact: Massimo Allegri, MD | 00390382 ext 502627 | m.allegri@smatteo.pv.it |
Locations
| Italy | |
| IRCCS Policlinico San Matteo | Recruiting |
| Pavia, Lomabardy, Italy, 27100 | |
| Contact: Fabrizio Cavalloro, MD 00390382 ext 502627 f.cavalloro@smatteo.pv.it | |
| Principal Investigator: Fabrizio Cavalloro, MD | |
| Ospedale di Circolo e Fondazione Macchi | Not yet recruiting |
| Varese, Lombardy, Italy, 21100 | |
| Contact: Andrea Ambrosoli, MD 00390332 278 ext 111 | |
| Principal Investigator: Andrea Ambrosoli, MD | |
Sponsors and Collaborators
IRCCS Policlinico S. Matteo
University of Pavia
Investigators
| Principal Investigator: | Fabrizio Cavalloro, MD | IRCCS Policlinico San Matteo |
More Information
No publications provided
| Responsible Party: | Massimo Allegri, MD, IRCCS Policlinico S. Matteo |
| ClinicalTrials.gov Identifier: | NCT01345162 History of Changes |
| Other Study ID Numbers: | 2009-011856-23 |
| Study First Received: | April 19, 2011 |
| Last Updated: | January 19, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by IRCCS Policlinico S. Matteo:
|
Herniotomy |
Additional relevant MeSH terms:
|
Hernia Pathological Conditions, Anatomical Analgesics Tramadol Ketorolac Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Narcotics Central Nervous System Depressants Analgesics, Opioid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013