OFA vs OBA in Bariatric Surgery

NCT07075302 | Completed

• 1 other identifier: 25.04.2517-GHM
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Opioid-Free Anesthesia; Bariatric Surgery; opioid-based anesthesia; morphine consumption; TIVA; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• Total postoperative morphine consumption (mg)

  Cumulative amount of morphine (in milligrams) administered within the first 48 hours after surgery, as recorded in the post-anesthesia care unit and inpatient medical records.

  From 0 to 48 hours after surgery

Secondary Outcomes (5)

• Pain intensity (VAS)

  At 1, 2, 4, 24, and 48 hours postoperatively

• Sedation level (RAMSAY scale)

  From 0 to 48 hours after surgery

• Incidence of adverse events

  Up to 48 hours after surgery

• Length of hospital stay

  From surgery until discharge (up to 7 days)

• Time to awakening

  Intraoperative period until recovery (measured at end of surgery)

Study Arms (2)

OFA Group

Patients who received opioid-free total intravenous anesthesia (TIVA) for bariatric surgery, including propofol, lidocaine, ketamine, dexmedetomidine and magnesium, with no intraoperative opioids.

OBA Group

Patients who received opioid-based total intravenous anesthesia (TIVA) for bariatric surgery, including propofol and intraoperative opioids such as fentanyl, remifentanil and morphine, following standard practice.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (18-65 years) with obesity (BMI ≥ 30 kg/m²) classified as ASA II-III, who underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos between June 2022 and December 2023. Patients were retrospectively assigned to one of two groups based on the anesthetic technique used: opioid-free anesthesia (OFA) or opioid-based anesthesia (OBA).

You may qualify if:

• Body Mass Index (BMI) ≥ 30 kg/m²
• ASA physical status II or III
• Underwent laparoscopic bariatric surgery under general anesthesia at HM Nou Delfos
• Surgery performed between June 1, 2022 and December 31, 2023

You may not qualify if:

• Chronic pain patients on high-dose opioids
• Known allergy to any anesthetic drug used in the study
• Severe hepatic (e.g., cirrhosis with portal hypertension) or renal insufficiency
• Untreated coagulopathy
• Active alcohol or drug abuse
• Uncontrolled or severe psychiatric illness
• Intraoperative complications requiring deviation from planned anesthetic technique
• Postoperative morphine use exceeding institutional norms for bariatric surgery

Sponsors & Collaborators

• Hospital HM Nou Delfos: lead

Study Sites (1)

Hospital HM Nou Delfos

Barcelona, Barcelona, 08023, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Obesity; Pain, Postoperative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Gregory Contreras-Pérez, Anesthesiologist

  Hospital HM NouDelfos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)