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

• ClinicalTrials.gov Identifier: NCT03330808
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Last Update Posted: May 18, 2020
• Sponsor: Asan Medical Center
• Information provided by (Responsible Party): Young-Kug Kim, Asan Medical Center

Tracking Information

• First Submitted Date: October 30, 2017
• First Posted Date: November 6, 2017
• Last Update Posted Date: May 18, 2020
• Actual Study Start Date: October 28, 2017
• Actual Primary Completion Date: April 5, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 31, 2017)

Maximal blood flow velocity [ Time Frame: 30 minutes after flap arterial anastomosis ]

Maximal blood flow velocity measured by using Duplex ultrasound

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 31, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap
• Official Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Other
• Condition: Free Tissue Flaps

Intervention

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 Name: Epidural anesthesia with ropivacaine

Study Arms

• Experimental: Epidural with general anesthesia
  Epidural anesthesia with 0.2% ropivacaine 10 ml
  Intervention: Other: Epidural anesthesia
• No Intervention: General anesthesia alone
  Sevoflurane and nitrous oxide.

Publications *

• Wright CJ, Cousins MJ. Blood flow distribution in the human leg following epidural sympathetic blockade. Arch Surg. 1972 Aug;105(2):334-7.
• 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.
• Pallarés 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 31, 2017): 52
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 5, 2020
• Actual Primary Completion Date: April 5, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 79 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03330808
• Other Study ID Numbers: 2017-1200
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Young-Kug Kim, Asan Medical Center
• Study Sponsor: Asan Medical Center
• Collaborators: Not Provided

Investigators

• Principal Investigator: Young-Kug Kim, MD, PhD; Asan Medical Center

• PRS Account: Asan Medical Center
• Verification Date: May 2020