Free Tissue FlapsNCT03330808
Effect of Epidural Anesthesia on Blood Flow in Arterial Anastomosis of Free Flap
A study testing Epidural anesthesia in people with Free Tissue Flaps, run by Asan Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Free Tissue Flaps
- What is being tested?
- Epidural anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Oct 2017to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Free Tissue Flaps
- Being tested
- Epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaOther
Also called Epidural anesthesia with ropivacaine
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.
| Study group | Role | What they receive |
|---|---|---|
| Epidural with general anesthesia | Experimental | Epidural anesthesia with 0.2% ropivacaine 10 ml Receives: Other: Epidural anesthesia |
| General anesthesia alone | No intervention | Sevoflurane and nitrous oxide. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal blood flow velocity
Maximal blood flow velocity measured by using Duplex ultrasound
Measured: 30 minutes after flap arterial anastomosis
Secondary outcomes (7)
Blood volume
Blood volume measured by using Duplex ultrasound
Measured: 30 minutes after flap arterial anastomosis
Arterial blood pressure
Arterial blood pressure measured monitors
Measured: 30 minutes after flap arterial anastomosis
Cardiac output
Cardiac output measured monitors
Measured: 30 minutes after flap arterial anastomosis
Pulse pressure variability
Pulse pressure variability measured monitors
Measured: 30 minutes after flap arterial anastomosis
Body temperature
Body temperature measured monitors
Measured: 30 minutes after flap arterial anastomosis
Arterial carbon dioxide concentration
Arterial carbon dioxide concentration measured arterial blood gas analysis
Measured: 30 minutes after flap arterial anastomosis
Free flap failure
Free flap failure after surgery
Measured: Day 7 after free flap surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start28 Oct 2017
- Primary completion5 Apr 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Free Tissue FlapsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, Asan Medical Center
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330808
- Sponsor's protocol ID
- 2017-1200
- Status last verified
- May 2020
- First submitted
- 30 Oct 2017
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 5044554Tuman 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.
PubMed 1952169Pallares 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.
PubMed 8050457Lou 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.
PubMed 26910694Delis 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.
PubMed 15543327
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03330808
- Acronym / sponsor ID
- 2017-1200
- Conditions
- Free Tissue Flaps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 28 Oct 2017 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural with general anesthesia | Experimental | Other: Epidural anesthesiaEpidural anesthesia with 0.2% ropivacaine 10 ml |
| General anesthesia alone | No intervention | –Sevoflurane and nitrous oxide. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaAlso: Epidural anesthesia with ropivacaineAfter 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 | Epidural with general anesthesia |
Primary outcome
Maximal blood flow velocity
Time frame: 30 minutes after flap arterial anastomosis
Maximal blood flow velocity measured by using Duplex ultrasound
7 secondary outcomes
Blood volume
Time frame: 30 minutes after flap arterial anastomosis
Arterial blood pressure
Time frame: 30 minutes after flap arterial anastomosis
Cardiac output
Time frame: 30 minutes after flap arterial anastomosis
Pulse pressure variability
Time frame: 30 minutes after flap arterial anastomosis
Body temperature
Time frame: 30 minutes after flap arterial anastomosis
Arterial carbon dioxide concentration
Time frame: 30 minutes after flap arterial anastomosis
Free flap failure
Time frame: Day 7 after free flap surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Background: PubMed 5044554Wright 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.
- Background: PubMed 1952169Tuman 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.
- Background: PubMed 8050457Pallares 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.
- Background: PubMed 26910694Lou 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.
- Background: PubMed 15543327Delis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural anesthesia in people with Free Tissue Flaps, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal blood flow velocity (time frame: 30 minutes after flap arterial anastomosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03330808, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.