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

This study has been completed.
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: May 21, 2014
Last verified: May 2014
  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: Ketorolac postoperative
Drug: postoperative Patrol
Drug: intraoperative analgesia
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:
  • Analgesic Efficacy [ Time Frame: 4 days postherniotomy ] [ Designated as safety issue: No ]

    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.



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.


Enrollment: 200
Study Start Date: March 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Toradol
Drug: intraoperative analgesia
ketorolac 30 mg iv
Other Name: Ketorolac
Drug: intraoperative analgesia
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Other Name: Tramadol
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: postoperative Patrol
acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
Other Name: Patrol
Drug: intraoperative analgesia
ketorolac 30 mg iv
Other Name: Ketorolac
Drug: intraoperative analgesia
Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
Other Name: 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345162

Locations
Italy
IRCCS Policlinico San Matteo
Pavia, Lomabardy, Italy, 27100
Ospedale di Circolo e Fondazione Macchi
Varese, Lombardy, Italy, 21100
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
Results First Received: March 17, 2014
Last Updated: May 21, 2014
Health Authority: Italy: Ministry of Health

Keywords provided by IRCCS Policlinico S. Matteo:
Herniotomy

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical
Tramadol
Ketorolac
Ketorolac Tromethamine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
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 August 19, 2014