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Major and Minor Surgical ComplicationsDIEPflapNCT03202134

Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery

An observational study of Major and Minor Surgical Complications, run by AZ Sint-Jan AV at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Major and Minor Surgical Complications
What is being tested?
opioid free anesthesia
Type of treatment
Injection or infusion
How many people
204 participants
Where
1 siteBelgium
Study dates
Jan 2014to 15 Nov 2019
How long will I take part?
1 Month
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: woman who are admitted for breast reconstruction using the diepflap (free flap)

Who may be able to join

None listed.

Who cannot join

  • allergy to any of the drugs used in anesthesia

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Azsintjan

    Bruges, 8000

Other trials in Belgium

About this study

Official title: Impact of Opioid Free Anesthesia on the Complications After DIEPflap Surgery: A Retrospective Observational Cohort Study.

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.

Read more

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.

Read the detailed 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.

Being tested
opioid free anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • opioid free anesthesiaOther

    general anesthesia blocking reflexes without using an opioid

Study groups in NCT03202134
Study groupRoleWhat they receive
opioid free anesthesia (OFA)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.
Receives: Other: opioid free anesthesia
opioid anesthesia (OA)OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients With One or More Complications

    number of minor and major complications (CLAVIEN) (DINDOO)

    Measured: One month postoperative

Secondary outcomes (5)
  1. Number of Patients With Post Operative Nausea or Vomiting

    number of patients having Post operative nausea or vomiting (PONV)

    Measured: 24 hours postoperative

  2. Postoperative Pain: Visual Analog Scale

    postoperative Pain measured by visual analog scale: 0: no pain. 10 max pain

    Measured: 24 hours postoperative

  3. Morphine Used

    morphine consumed in mg

    Measured: 24 hours postoperative

  4. Skin Temperature

    temperature difference between free flap skin and central patient skin

    Measured: 24 hours post operative

  5. Length of Hospital Stay

    length of hospital stay in days

    Measured: up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2017
  2. Study startJan 2014
  3. Primary completion15 Nov 2019
  4. Study completion15 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
204 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT03202134
Sponsor's protocol ID
2019OSOFADIEPFLAP
Acronym
DIEPflap
Status last verified
Feb 2021
First submitted
26 Jun 2017
Last updated
23 Feb 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Major and Minor Surgical Complications, run by AZ Sint-Jan AV at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With One or More Complications (time frame: One month postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.

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