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

Free Tissue Flaps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03330808
• Other study ID #: 2017-1200
• Status: Completed
• Phase: N/A
• Start date: October 28, 2017
• Est. completion date: May 5, 2020

Study information

• Verified date: May 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: May 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal blood flow velocity	Maximal blood flow velocity measured by using Duplex ultrasound	30 minutes after flap arterial anastomosis
Secondary	Blood volume	Blood volume measured by using Duplex ultrasound	30 minutes after flap arterial anastomosis
Secondary	Arterial blood pressure	Arterial blood pressure measured monitors	30 minutes after flap arterial anastomosis
Secondary	Cardiac output	Cardiac output measured monitors	30 minutes after flap arterial anastomosis
Secondary	Pulse pressure variability	Pulse pressure variability measured monitors	30 minutes after flap arterial anastomosis
Secondary	Body temperature	Body temperature measured monitors	30 minutes after flap arterial anastomosis
Secondary	Arterial carbon dioxide concentration	Arterial carbon dioxide concentration measured arterial blood gas analysis	30 minutes after flap arterial anastomosis
Secondary	Free flap failure	Free flap failure after surgery	Day 7 after free flap surgery