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

NCT ID: NCT03330808

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-28

Study Completion Date

2020-05-05

Brief Summary

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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

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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.

Conditions

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Free Tissue Flaps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Epidural with general anesthesia

Epidural anesthesia with 0.2% ropivacaine 10 ml

Group Type EXPERIMENTAL

Epidural anesthesia

Intervention Type OTHER

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.

General anesthesia alone

Sevoflurane and nitrous oxide.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Epidural anesthesia with ropivacaine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Young-Kug Kim

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 5044554 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1952169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8050457 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26910694 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15543327 (View on PubMed)

Other Identifiers

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2017-1200

Identifier Type: -

Identifier Source: org_study_id

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