Skip to content

Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap

Randomized Trials of Epidural Combined With General Anesthesia Versus General Anesthesia Alone to Evaluate the Changes of Blood Flow in Arterial Anastomosis of Free Flap Using Duplex Ultrasonography

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03330808
Enrollment
52
Registered
2017-11-06
Start date
2017-10-28
Completion date
2020-05-05
Last updated
2020-05-18

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

Conditions

Free Tissue Flaps

Brief summary

Comparing the changes of arterial anastomotic blood flow between general anesthesia alone and general anesthesia with epidural anesthesia in patients who undergoing free flap transposition using Duplex ultrasound.

Detailed description

Maintaining adequate blood flow is important on the success of free flap surgery. Epidural anesthesia can influence blood flow during surgery. Therefore, investigators aim to compare the effect of epidural anesthesia combined with general anesthesia and general anesthesia alone on blood flow in arterial anastomosis site of the free flap.

Interventions

OTHEREpidural anesthesia

After anesthesia induction, epidural catheter is inserted into lumbar epidural in epidural with general anesthesia group. A 10 ml of 0.2% ropivacaine should be given in epidural space via a catheter when anastomosis of free flap is finished in epidural with general anesthesia group.

Sponsors

Asan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No

Inclusion criteria

* Patients scheduled to undergo free flap transfer under general anesthesia. * 18 years of age or older, under 80 years of age * Those who voluntarily agreed to participate in this clinical study

Exclusion criteria

* If the patient does not agree to participate in the study * ASA physical status IV or higher * If the patient was diagnosed with diabetes * If the patient was diagnosed with chronic renal failure * If the patient was diagnosed with peripheral vascular disease or hyperlipidemia * If vasopressors or inotropics was used preoperatively. * Contraindication of epidural anesthesia such as usage of anticoagulant or abnormalities of laboratory finding. * If the researcher finds it to be inappropriate

Design outcomes

Primary

MeasureTime frameDescription
Maximal blood flow velocity30 minutes after flap arterial anastomosisMaximal blood flow velocity measured by using Duplex ultrasound

Secondary

MeasureTime frameDescription
Arterial blood pressure30 minutes after flap arterial anastomosisArterial blood pressure measured monitors
Cardiac output30 minutes after flap arterial anastomosisCardiac output measured monitors
Pulse pressure variability30 minutes after flap arterial anastomosisPulse pressure variability measured monitors
Blood volume30 minutes after flap arterial anastomosisBlood volume measured by using Duplex ultrasound
Arterial carbon dioxide concentration30 minutes after flap arterial anastomosisArterial carbon dioxide concentration measured arterial blood gas analysis
Free flap failureDay 7 after free flap surgeryFree flap failure after surgery
Body temperature30 minutes after flap arterial anastomosisBody temperature measured monitors

Countries

South Korea

Outcome results

None listed

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