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

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.

Study Overview

• Status: Completed
• Conditions: Free Tissue Flaps
• Intervention / Treatment: Other: Epidural anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epidural with general anesthesia; Epidural anesthesia with 0.2% ropivacaine 10 ml	Other: Epidural 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.; Other Names: Epidural anesthesia with ropivacaine
No Intervention: General anesthesia alone; Sevoflurane and nitrous oxide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximal blood flow velocity	Maximal blood flow velocity measured by using Duplex ultrasound	30 minutes after flap arterial anastomosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood volume	Blood volume measured by using Duplex ultrasound	30 minutes after flap arterial anastomosis
Arterial blood pressure	Arterial blood pressure measured monitors	30 minutes after flap arterial anastomosis
Cardiac output	Cardiac output measured monitors	30 minutes after flap arterial anastomosis
Pulse pressure variability	Pulse pressure variability measured monitors	30 minutes after flap arterial anastomosis
Body temperature	Body temperature measured monitors	30 minutes after flap arterial anastomosis
Arterial carbon dioxide concentration	Arterial carbon dioxide concentration measured arterial blood gas analysis	30 minutes after flap arterial anastomosis
Free flap failure	Free flap failure after surgery	Day 7 after free flap surgery

Collaborators and Investigators

• Sponsor: Asan Medical Center

Publications and helpful links

General Publications

• Wright CJ, Cousins MJ. Blood flow distribution in the human leg following epidural sympathetic blockade. Arch Surg. 1972 Aug;105(2):334-7. doi: 10.1001/archsurg.1972.04180080180030. No abstract available.
• Tuman KJ, McCarthy RJ, March RJ, DeLaria GA, Patel RV, Ivankovich AD. Effects of epidural anesthesia and analgesia on coagulation and outcome after major vascular surgery. Anesth Analg. 1991 Dec;73(6):696-704. doi: 10.1213/00000539-199112000-00005.
• Pallares LC, Deane CR, Baudouin SV, Evans TW. Strain gauge plethysmography and Doppler ultrasound in the measurement of limb blood flow. Eur J Clin Invest. 1994 Apr;24(4):279-86. doi: 10.1111/j.1365-2362.1994.tb01086.x.
• Lou F, Sun Z, Huang N, Hu Z, Cao A, Shen Z, Shao Z, Yu P, Miao C, Wu J. Epidural Combined with General Anesthesia versus General Anesthesia Alone in Patients Undergoing Free Flap Breast Reconstruction. Plast Reconstr Surg. 2016 Mar;137(3):502e-509e. doi: 10.1097/01.prs.0000479933.75887.82.
• Delis KT, Knaggs AL, Mason P, Macleod KG. Effects of epidural-and-general anesthesia combined versus general anesthesia alone on the venous hemodynamics of the lower limb. A randomized study. Thromb Haemost. 2004 Nov;92(5):1003-11. doi: 10.1160/TH04-04-0233.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2017
• Primary Completion (Actual): April 5, 2020
• Study Completion (Actual): May 5, 2020

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 31, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Ropivacaine
• Other Study ID Numbers: 2017-1200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No