Analgesic efficacy of intrawound local anesthetic and steroid

Phase 1

• Conditions: Patients undergoning major abdominal surgery requiring postoperative analgesic therapy, not hospitalized in intensive care and not using drugs by neuraxial analgesia; MedDRA version: 15.1Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2012-005265-13-IT
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-22
• Last Update Posted: 26 February 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Male and females 18-75 years old scheduled to use PCA with morphine for postoperative pain control
- HIV-negative
- Classification American Society of Anesthesiologists (ASA) I: without systemic disease
- Classification ASA II or III (moderate systemic disease or severe systemic disease that limits activity without disability)
- Scheduled for major abdominal and urologic surgery (no emergency surgery)
- Signed informed consent
- No severe hepatic or renal impairment (cholinesterase <3000 mU / ml, total bilirubiemia <2 mg / dl and creatinine <1.2 mg / dl)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- regular use of opioid analgesics;
- History of abuse of drugs and / or alcohol;
- Postoperative hospitalization in intensive care with sedation and / or mechanical ventilation;
- severe renal impairment (creatinine> 2 g / dl, creatinine clearance <30 ml / h) and / or hepatic impairment (cholinesterase <2000 IU);
- Cardiac disorders (arrhythmias, heart failure);
- Neurological disorders (epilepsy);
- Cognitive disorders, mental retardation, psychiatric disorders;
- Changes in the normal coagulation or coagulopathy (INR> 2, PTT> 44 sec);
- Platelet count less than 100.000/mm3;
- BMI> 30;
- immunodepression (WBC<5.000)
- Allergy to study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified