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Completed

NCT Number: NCT01345162

Assessment and Prevention 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.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

IRCCS Policlinico San Matteo, Pavia, Lomabardy, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac postoperative

Drug

Ketorolac 10mg 1cp x 3/die

Other names: Toradol

postoperative Patrol

Drug

acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die

Other names: Patrol

intraoperative analgesia

Drug

ketorolac 30 mg iv

Other names: Ketorolac

Primary outcomes

  1. Analgesic Efficacy

    Time frame: 4 days postherniotomy

    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 outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 4 days postherniotoy

    All adverse events (eg: PONV (postoperative nausea and vomiting), itching, dizziness, epigastralgia) are recorded.

    Assessment of any difference between the two groups.

  2. Difference in Recovering Daily Activity

    Time frame: 4 days after surgical procedure

    Assessment of the difference in recovering daily activity in terms of NRSm (Numeric Rate Scale at movement)

  3. Assessment of Any Connections Between the Two Therapeutical Strategies and the Recurrence of Surgical Complications

    Time frame: 4 days postherniotomy

    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. Development of Persistent Postoperative Pain

    Time frame: Up to 3 months

    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.

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Collaborators

  • University of Pavia

Registry information

Official study title

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

Acronym: PTSM04APHP

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 29, 2011
Registry last updated
Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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