EUCTR2012-005265-13-IT
Active, not recruiting
Phase 1
Efficacy of intralesional infusion of local anesthetics in patients undergoing major abdominal surgery: a randomized double-blind trial. - PT-SM-13-YR
ConditionsPatients undergoning major abdominal surgery requiring postoperative analgesic therapy, not hospitalized in intensive care and not using drugs by neuraxial analgesiaMedDRA version: 15.1Level: PTClassification code 10068093Term: Gastrointestinal surgerySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Not possible to specify
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients undergoning major abdominal surgery requiring postoperative analgesic therapy, not hospitalized in intensive care and not using drugs by neuraxial analgesia
- Sponsor
- Fondazione IRCCS Policlinico San Matteo
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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;
Outcomes
Primary Outcomes
Not specified
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