STUDY TO COMPARE THE POSTOPERATIVE ANALGESIA OF INTRAPERITONEAL NEBULIZED ROPIVACAIN BEFORE AND AFTER LAPAROSCOPIC GASTRIC BY-PASS SURGERY IN OBESITY PATIENTS

Phase 1

• Conditions: Post-surgical pain after gastric bypass surgery in obese patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001025-20-ES
• Lead Sponsor: Servicio de Anestesiología y Reanimación del Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-21
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- Patients programmed for laparoscopic Roux-Y gastric bypass surgery
- Age between 18 and 80 years old
- Informed consent
- BMI = 35 kg / m2
- That he agrees to participate in the study by signing the informed consent.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Reconversion to open surgery
- Allergy known to local anesthetics
- Psychiatric alterations that prevent the clinical evaluation of pain
- Previous history of chronic pain of any type with habitual opioid use
- Severe cardiovascular disease (NYHA = III): CHF, arrhythmias, decompensated cardiomyopathies.
- Treatment with class III antiarrhythmics (amiodarone, sotalol).
- IRC stadium 3 or more.
- Child-Pugh hepatic dysfunction class B or C.
- Previous gastrointestinal surgery.
- Acute porphyria
- If the surgery is reconverted to open, the patient will be excluded from the study.

Study & Design

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