An observational study in Major and Minor Surgical Complications, sponsored by AZ Sint-Jan AV. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-23.
Sponsored by AZ Sint-Jan AV · Observational
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.
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.
AZ Sint-Jan AV is the lead sponsor of 58 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
woman who are admitted for breast reconstruction using the diepflap (free flap)
Inclusion Criteria: DIEPflap unilat or bilat woman between 18 and 60 years old-
Exclusion Criteria: none
The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.
Other: opioid free anesthesia
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
general anesthesia blocking reflexes without using an opioid
Number of Patients With One or More Complications
number of minor and major complications (CLAVIEN) (DINDOO)
Time frame: One month postoperative
Number of Patients With Post Operative Nausea or Vomiting
number of patients having Post operative nausea or vomiting (PONV)
Time frame: 24 hours postoperative
Postoperative Pain: Visual Analog Scale
postoperative Pain measured by visual analog scale: 0: no pain. 10 max pain
Time frame: 24 hours postoperative
Morphine Used
morphine consumed in mg
Time frame: 24 hours postoperative
Skin Temperature
temperature difference between free flap skin and central patient skin
Time frame: 24 hours post operative
Length of Hospital Stay
length of hospital stay in days
Time frame: up to two weeks
| Milestone | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Started | 55 | 149 |
| Completed | 55 | 149 |
| Not completed | 0 | 0 |
number of minor and major complications (CLAVIEN) (DINDOO)
| Participants | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Number of Patients With One or More Complications | 10 | 85 |
number of patients having Post operative nausea or vomiting (PONV)
| Participants | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Number of Patients With Post Operative Nausea or Vomiting | 7 | 65 |
postoperative Pain measured by visual analog scale: 0: no pain. 10 max pain
| score on a scale | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Postoperative Pain: Visual Analog Scale | 1.87 ± 0.65 | 4.94 ± 0.54 |
morphine consumed in mg
| milligram | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Morphine Used | 1.95 ± 0.84 | 4.94 ± 0.54 |
temperature difference between free flap skin and central patient skin
| degrees Celsius | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Skin Temperature | 1.04 ± 0.25 | 1.41 ± 0.21 |
length of hospital stay in days
| days | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Length of Hospital Stay | 6.82 ± 0.26 | 7.52 ± 0.28 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid Free Anesthesia (OFA) | 0/55 (0%) | 1/55 (1.8%) | 9/55 (16.4%) |
| Opioid Anesthesia (OA) | 0/149 (0%) | 9/149 (6%) | 67/149 (45%) |
| Event | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Revision surgerySurgical and medical procedures | 1/55 | 9/149 |
| Event | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) |
|---|---|---|
| Post operative nausea and vomitingSurgical and medical procedures | 9/55 | 67/149 |
| Age, Continuous(years) | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) | Total |
|---|---|---|---|
| Mean | 53.9 ± 2.8 | 50.3 ± 1.7 | 51.6 ± 1.4 |
| Sex/Gender, Customized(Participants) | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) | Total |
|---|---|---|---|
| Sex:Female | 55 | 149 | 204 |
| Race and Ethnicity Not Collected(Participants) | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| history of nausea after anesthesia(Participants) | Opioid Free Anesthesia (OFA) | Opioid Anesthesia (OA) | Total |
|---|---|---|---|
| Count of participants | 6 | 19 | 25 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AZ Sint-Jan AV