Assessment and Prevention of Acute Post-herniotomy Pain
- Conditions
- Hernia
- Interventions
- Registration Number
- NCT01345162
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketorolac Ketorolac postoperative 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. ketorolac intraoperative analgesia 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. acetaminophene+tramadol postoperative Patrol 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. acetaminophene+tramadol intraoperative analgesia 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.
- Primary Outcome Measures
Name Time Method Analgesic Efficacy 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 Outcome Measures
Name Time Method Number of Participants With Adverse Events as a Measure of Safety and Tolerability 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.Difference in Recovering Daily Activity 4 days after surgical procedure 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 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.Development of Persistent Postoperative Pain 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.
Trial Locations
- Locations (2)
Ospedale di Circolo e Fondazione Macchi
🇮🇹Varese, Lombardy, Italy
IRCCS Policlinico San Matteo
🇮🇹Pavia, Lomabardy, Italy