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Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03202134
Acronym
DIEPflap
Enrollment
204
Registered
2017-06-28
Start date
2014-01-31
Completion date
2019-11-15
Last updated
2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major and Minor Surgical Complications

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.

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.

Interventions

OTHERopioid free anesthesia

general anesthesia blocking reflexes without using an opioid

Sponsors

AZ Sint-Jan AV
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients With One or More ComplicationsOne month postoperativenumber of minor and major complications (CLAVIEN) (DINDOO)

Secondary

MeasureTime frameDescription
Number of Patients With Post Operative Nausea or Vomiting24 hours postoperativenumber of patients having Post operative nausea or vomiting (PONV)
Postoperative Pain: Visual Analog Scale24 hours postoperativepostoperative Pain measured by visual analog scale: 0: no pain. 10 max pain
Morphine Used24 hours postoperativemorphine consumed in mg
Skin Temperature24 hours post operativetemperature difference between free flap skin and central patient skin
Length of Hospital Stayup to two weekslength of hospital stay in days

Countries

Belgium

Participant flow

Participants by arm

ArmCount
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. opioid free anesthesia: general anesthesia blocking reflexes without using an opioid
55
Opioid Anesthesia (OA)
OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.
149
Total204

Baseline characteristics

CharacteristicOpioid Free Anesthesia (OFA)Opioid Anesthesia (OA)Total
Age, Continuous53.9 years
STANDARD_DEVIATION 2.8
50.3 years
STANDARD_DEVIATION 1.7
51.6 years
STANDARD_DEVIATION 1.4
history of nausea after anesthesia6 Participants19 Participants25 Participants
Race and Ethnicity Not Collected0 Participants
Sex/Gender, Customized
Sex:Female
55 Participants149 Participants204 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 149
other
Total, other adverse events
9 / 5567 / 149
serious
Total, serious adverse events
1 / 559 / 149

Outcome results

Primary

Number of Patients With One or More Complications

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

Time frame: One month postoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Free Anesthesia (OFA)Number of Patients With One or More Complications10 Participants
Opioid Anesthesia (OA)Number of Patients With One or More Complications85 Participants
p-value: <0.001Chi-squared
Secondary

Length of Hospital Stay

length of hospital stay in days

Time frame: up to two weeks

ArmMeasureValue (MEAN)Dispersion
Opioid Free Anesthesia (OFA)Length of Hospital Stay6.82 daysStandard Deviation 0.26
Opioid Anesthesia (OA)Length of Hospital Stay7.52 daysStandard Deviation 0.28
Secondary

Morphine Used

morphine consumed in mg

Time frame: 24 hours postoperative

ArmMeasureValue (MEAN)Dispersion
Opioid Free Anesthesia (OFA)Morphine Used1.95 milligramStandard Deviation 0.84
Opioid Anesthesia (OA)Morphine Used4.94 milligramStandard Deviation 0.54
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

Number of Patients With Post Operative Nausea or Vomiting

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

Time frame: 24 hours postoperative

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Opioid Free Anesthesia (OFA)Number of Patients With Post Operative Nausea or Vomiting7 Participants
Opioid Anesthesia (OA)Number of Patients With Post Operative Nausea or Vomiting65 Participants
p-value: <0.001Chi-squared
Secondary

Postoperative Pain: Visual Analog Scale

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

Time frame: 24 hours postoperative

ArmMeasureValue (MEAN)Dispersion
Opioid Free Anesthesia (OFA)Postoperative Pain: Visual Analog Scale1.87 score on a scaleStandard Deviation 0.65
Opioid Anesthesia (OA)Postoperative Pain: Visual Analog Scale4.94 score on a scaleStandard Deviation 0.54
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary

Skin Temperature

temperature difference between free flap skin and central patient skin

Time frame: 24 hours post operative

ArmMeasureValue (MEAN)Dispersion
Opioid Free Anesthesia (OFA)Skin Temperature1.04 degrees CelsiusStandard Deviation 0.25
Opioid Anesthesia (OA)Skin Temperature1.41 degrees CelsiusStandard Deviation 0.21
p-value: 0.048Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026