NCT06383234
Completed
Not Applicable
REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
Fondazione Policlinico Universitario Campus Bio-Medico1 site in 1 country110 target enrollmentJanuary 10, 2022
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Pain Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).
Investigators
Vincenzo Bruni
Principal Invesigator
Fondazione Policlinico Universitario Campus Bio-Medico
Eligibility Criteria
Inclusion Criteria
- •Elective Laparoscopic Sleeve Gastrectomy
- •Body Mass Index (BMI) \> 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
- •BMI \> 40 kg/m², even in the absence of comorbidities
- •ASA physical status score \< 4
Exclusion Criteria
- •ASA physical status score ≥ 4
- •Patient's refusal or inability to sign the informed consent
- •Allergies to any drug provided by the study protocol
Outcomes
Primary Outcomes
Pain Score
Time Frame: 24 hours
A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery
Secondary Outcomes
- Nausea and/or vomiting(48 hours)
- Time to walking(72 hours)
- Surgical Complication(7 days)
- Time to first flatus(72 hours)
- Morphine Consumption(24 hours)
- Toradol Consumption(24 hours)
- Lenght of Hospital Stay(72 hours)
Study Sites (1)
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