Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03202134 |
| Other study ID # |
2019OSOFADIEPFLAP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 2014 |
| Est. completion date |
November 15, 2019 |
Study information
| Verified date |
February 2021 |
| Source |
AZ Sint-Jan AV |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
The investigators included all patients in the hospital database.belgium who underwent
DIEPflap surgery between Jan 2014 and April 2019. All patients entering the hospital provided
consent to allow retrospective data analysis without patient identification.
Because patient assignment to an operating day was determined without knowing who would
perform the anesthesia on a few exceptions, the choice of opioid free anesthesia (OFA) or
opioid anesthesia (OA) in most cases was random. Patients were classified as receiving OFA
when no opioids were given pre- or intra- operatively until wound closure. Opioids given
after wound closure were counted as post-operative opioids. Patients who received a lower
dose of intra-operative opioids by using additives were still classified as OA.
Post-operative opioid free analgesia was classified as receiving no opioids after wound
closure until discharge from hospital in patients not receiving medium- or long-acting
opioids, pre- or intra-operatively.
The method of reaching OFA remained stable since 2014. Dexmedetomidine was given in a first
loading dose of 0.3 mcg/kg 15 minutes before induction, a second loading dose of 0.1 mcg/kg
at induction followed by an infusion of 0.1 mcg/kg/h for maintenance. Lidocaine is given as a
loading dose of 1 mg/kg at induction followed by 1 mg/kg/h for maintenance. A Ketamine
loading dose of 0.1 mg/kg is given at induction with an extra bolus of 0.7 mg/kg (or max 50
mg) before incision followed by an infusion of 0.1mg/kg/h.
Post-operative analgesia was further improved by continuing very low doses of dexmedetomidine
(0.05 mcg/kg/h), ketamine (0.05 mg/kg/h), and lidocaine (0.5 mg/kg/h) for the first hours
(maximum 5 hours) with the possibility of giving a bolus of 10 mg lidocaine, 1 mg ketamine
and 1 mcg dexmedetomidine every 15 minutes.
OA was induced with sufentanil (0.1 - 0.3 mcg/kg) and continued with extra boli (0.1 - 0.2
mcg/kg) or a continuous infusion of remifentanil (0.20 - 0.35 mcg/kg/h). Since 2014 more and
more additives like clonidine, dexmedetomidine, ketamine and lidocaine were given as a single
additive at the induction to reduce the total dose of intraoperative opioid use. Nevertheless
these patients were still counted as OA.
All patients getting OFA got a strict goal directed fluid therapy with an average amount of
fluids between 600 and 1200 ml. Patients on OA got a more liberal fluid therapy resulting in
total amounts between 3000 and 5000 ml. For each patient the total amount of fluids given
intra operative and the duration of the surgical procedure is calculated.
Following demographic data was retrieved: age, body mass index (BMI), American society of
anesthesiology (ASA) score, incidence of hypertension, smoking or history of recent smoking,
motion sickness or previous PONV. A bilateral DIEPflap is noted as bilat versus unilat and
depending on the use of opioids postoperative an Apfel score is calculated. The number of
anti emetic drugs given before any PONV took place and the number given after PONV is
calculated, the incidence of nausea and the incidence of vomiting is measured. The maximum
visual analog score (VAS) during the first 24 hours and the total equivalent dose of morphine
used in the first 24 hours is measured.
Postoperative flap skin temperature was measured every hour in the first 24 hours and
compared to a reference skin temperature close by.
Perioperative complications during the first post-operative month were graded according to a
score (CLAVIEN), (DINDOO).
DIEPflap failure was defined as the need for a revision procedure that fails in preserving
the flap and requires a new or other flap procedure.
The investigators calculated length of hospital stay (LOS) as the total number of nights in
hospital after surgery.
The investigators retrieved all measured factors potentially related to complications of
grade I to grade V or healthcare utilization outcomes from the database and medical records.
Post-operative opioids were defined as the total dose of opioids used during the first 24
hours post-operatively, calculated as iv morphine equivalents. The following were considered
equivalent to 1 mg iv morphine: 1 mg iv or subcutaneous piritramide, 10 mg iv tramadol, or 2
mg sublingual oxycodone.
