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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07075302
Acronym
OFA VS OBA1
Enrollment
70
Registered
2025-07-20
Start date
2022-06-01
Completion date
2024-01-31
Last updated
2025-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Hospital HM Nou Delfos
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Age between 18 and 65 years 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

Exclusion criteria

Pregnancy or breastfeeding 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

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative morphine consumption (mg)From 0 to 48 hours after surgeryCumulative 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.

Secondary

MeasureTime frameDescription
Pain intensity (VAS)At 1, 2, 4, 24, and 48 hours postoperativelyPain evaluated using the Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), both at rest and with movement.
Sedation level (RAMSAY scale)From 0 to 48 hours after surgerySedation assessed using the Ramsay Sedation Scale, ranging from 1 (anxious/agitated) to 6 (no response to stimuli).
Incidence of adverse eventsUp to 48 hours after surgeryNumber of patients experiencing side effects such as nausea, vomiting, pruritus, hypotension, bradycardia, ileus, or urinary retention.
Length of hospital stayFrom surgery until discharge (up to 7 days)Total duration of hospital stay in days, calculated from the day of surgery to discharge date.
Time to awakeningIntraoperative period until recovery (measured at end of surgery)Time in minutes from the end of surgery until patient opens eyes or responds to verbal commands.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026