NCT07075302

OFA vs OBA in Bariatric Surgery

Comparison of Postoperative Morphine Requirements Between an Opioid-Based and an Opioid-Free Anesthesia Technique in Morbidly Obese Patients Undergoing Bariatric Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: Hospital HM Nou Delfos · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study compares two different anesthesia techniques in patients with obesity undergoing bariatric surgery: one that includes opioids (OBA), and one that avoids them completely (OFA). The main goal is to determine whether avoiding opioids during surgery leads to lower postoperative morphine requirements and fewer side effects. Researchers reviewed medical records of 70 patients who had bariatric surgery between June 2022 and December 2023 at a hospital in Spain. The study evaluates pain levels, sedation, complications, and total morphine use in the first 48 hours after surgery.

Detailed description

This is a single-center, retrospective, observational cohort study conducted at Hospital HM Nou Delfos (Barcelona, Spain). The aim is to compare postoperative opioid requirements and outcomes in patients with morbid obesity undergoing laparoscopic bariatric surgery, according to the intraoperative anesthesia technique used. Two anesthetic strategies were evaluated: Opioid-Free Anesthesia (OFA): Total intravenous anesthesia (TIVA) without opioids, using agents such as propofol, ketamine, dexmedetomidine, lidocaine and magnesium. Opioid-Based Anesthesia (OBA): TIVA including opioids, following institutional standards. Medical records of 70 patients (35 in each group) who underwent surgery between June 2022 and December 2023 were analyzed. Key data extracted included demographics, surgical duration, anesthetic drugs used, intraoperative complications, pain scores (VAS at 1, 2, 4, 24, and 48 hours), sedation levels (RAMSAY scale), adverse effects (e.g., nausea, vomiting, ileus, hypotension), and morphine consumption. The primary outcome is total morphine use within the first 48 hours postoperatively. Secondary outcomes include pain scores, adverse events, time to awakening, and hospital length of stay. Statistical analysis was performed using descriptive and inferential methods, including regression models adjusted for age, sex, BMI, and comorbidities. This study provides real-world evidence on the clinical impact of opioid-free anesthesia in bariatric patients, aiming to improve perioperative safety and enhance postoperative recovery.

Conditions

• Obesity
• Postoperative Pain
• Bariatric Surgery
• Opioid-free Anesthesia

Timeline

• Start date: 2022-06-01
• Primary completion: 2023-12-31
• Completion: 2024-01-31
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: Spain