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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by IRCCS Policlinico S. Matteo.
Recruitment status was  Recruiting
Sponsor:
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
  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
  1. Ketorolac 10mg 1cp x 3/die
  2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die
Other Names:
  • Toradol
  • Patrol
acetaminophene + tramadol

acetaminophene 325mg+tramadol 37,5mg

1cp x 3/die

Drug: postoperative analgesic treatment
  1. Ketorolac 10mg 1cp x 3/die
  2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die
Other Names:
  • Toradol
  • 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.

  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:
Analgesics
Analgesics, Opioid
Analgesics, Non-Narcotic
Hernia
Pathological Conditions, Anatomical
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
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014