Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery

NCT03202134 | Completed Results

• 1 other identifier: 2019OSOFADIEPFLAP
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Major and Minor Surgical Complications

Outcome Measures

Primary Outcomes (1)

• Number of Patients With One or More Complications

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

  One month postoperative

Secondary Outcomes (5)

• Number of Patients With Post Operative Nausea or Vomiting

  24 hours postoperative

• Postoperative Pain: Visual Analog Scale

  24 hours postoperative

• Morphine Used

  24 hours postoperative

• Skin Temperature

  24 hours post operative

• Length of Hospital Stay

  up to two weeks

Study Arms (2)

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.

Other: opioid free anesthesia

opioid anesthesia (OA)

OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.

Interventions

opioid free anesthesia OTHER

general anesthesia blocking reflexes without using an opioid

opioid free anesthesia (OFA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: breast reconstructive surgery is included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• allergy to any of the drugs used in anesthesia

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

Azsintjan

Bruges, 8000, Belgium

Location

Results Point of Contact

• Title: Jan Mulier
• Organization: AZSintJanAV

jan.mulier@azsintjan.be

003250452490

Study Officials

• Jan Paul Mulier

  AZSint Jan AV

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chairman dep anesthesiology & Reanimation

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: June 28, 2017
• Study Start: January 1, 2014
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: February 23, 2021
• Results First Posted: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)