Opioid-free Anesthesia Protocol on the Early Quality of Recovery after Major Surgery (SOFA Trial): A Randomized Clinical Trial
Primary result · QoR-15Result — go to the resultDifference 6.2 95% CI 0.4–12.0Authors' conclusion
The opioid-free anesthesia protocol improved quality of recovery after major elective surgery in a statistically but not clinically significant manner when compared to standard anesthesia.
Study context
- Population
- Patients undergoing scheduled major surgery (excluding bone procedures) typically requiring opioids for postoperative pain135 analysed
- Participants
- 136 patients
- Comparison
- Opioid-free anesthesia protocol vs standard anesthesia with opioids
- Opioid-free anesthesian = 67
- Standardn = 68reference
- Primary endpoint
- Early postoperative quality of recovery (QoR-15 score)
- Follow-up
- 24 h after surgery
Methodological detailsmonocentric, assessor- and patient-blinded
- Monocentric
- Assessor- and patient-blinded
Primary result
QoR-15 · 24 h
Difference
6.2
95% CI 0.4–12.0
P = 0.026
By group
Opioid-free anesthesia
114.9
mean · SD 15.2
Standard
108.7
mean · SD 18.1
Opioid-free anesthesia vs Standard
difference 6.2 (95% CI 0.4–12.0); P = 0.026
As reported in the abstract
Secondary outcomes
QoR-15 · 48 h
- QoR-15 differed significantly at 48 h; difference
- 8.7
- 95% CI
- 2.9 to 14.5
- P
- P = 0.004
QoR-15 · 72 h
- QoR-15 differed significantly at 72 h; difference
- 7.3
- 95% CI
- 1.6 to 13.0
- P
- P = 0.013
Incidence of chronic pain and quality of life · 3 months
- No differences in other secondary outcomes
Safety
- No major adverse events noticed
Original publication
Opioid-free Anesthesia Protocol on the Early Quality of Recovery after Major Surgery (SOFA Trial): A Randomized Clinical Trial. Anesthesiology. Published 17 November 2023. doi:10.
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