N/A
N=204
Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery
Major and Minor Surgical Complications
Bottom Line
View on ClinicalTrials.gov: NCT03202134 ↗Enrolled (actual)
204
Serious AEs
4.9%
Results posted
Feb 2021
Primary outcome: Primary: Number of Patients With One or More Complications — 10; 85 Participants — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- opioid free anesthesia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AZ Sint-Jan AV
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With One or More Complications |
10; 85 | <0.001 sig |
| SECONDARY Number of Patients With Post Operative Nausea or Vomiting |
7; 65 | <0.001 sig |
| SECONDARY Postoperative Pain: Visual Analog Scale |
1.87; 4.94 | <0.001 sig |
| SECONDARY Morphine Used |
1.95; 4.94 | <0.001 sig |
| SECONDARY Skin Temperature |
1.04; 1.41 | 0.048 sig |
| SECONDARY Length of Hospital Stay |
6.82; 7.52 | — |
Summary
The Deep Inferior Epigastric Perforator free flap (DIEPflap) involves the transfer of abdominal tissue to the breast using microsurgery. Flap failure is rare today, but is devastating.
Blood flow in a DIEPflap decreases during the first hours. Many anesthetic factors like low cardiac output, hypothermia and surgical stress cause vasoconstriction or thrombosis.
A stable anesthesia during these long procedures improves flap perfusion. Postoperative nausea and vomiting (PONV) is frequent and might have an impact.
Opioid free anesthesia (OFA) reduces PONV. The anti-inflammatory and vasodilator effects of the drugs dexmedetomidine and lidocaine might improve free flap perfusion.
The primary outcome counted all complications. The secondary outcomes were PONV, pain, opioid consumption, skin flap temperature and length of hospital stay.
Patients get according to attending anesthesiologist an opioid or opioid free anesthesia without any randomization but based on availability of competence.
Eligibility Criteria
Inclusion Criteria: DIEPflap unilat or bilat woman between 18 and 60 years old-
Exclusion Criteria: none
- allergy to any of the drugs used in anesthesia
Data sourced from ClinicalTrials.gov (NCT03202134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.