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

IRCCS Policlinico S. Matteo

Status and phase: Completed; Phase 4

Conditions: Hernia

Treatments: Drug: Ketorolac postoperative; Drug: intraoperative analgesia; Drug: postoperative Patrol

Study type: Interventional

Funder types: Other

Identifiers

NCT01345162

2009-011856-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

ketorolac

Other group

Description:

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.

Treatment:

Drug: intraoperative analgesia

Drug: intraoperative analgesia

Drug: Ketorolac postoperative

acetaminophene+tramadol

Other group

Description:

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.

Treatment:

Drug: postoperative Patrol

Drug: intraoperative analgesia

Drug: intraoperative analgesia