Postoperative PainNCT02235506
A Comparison of Epidural Block With Adding Sciatic Block to Continuous Femoral Block in Total Knee Arthroplasty
A study testing epidural infusion and femoral sciatic in people with Postoperative Pain, run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- epidural infusion and femoral sciatic
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Jun 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists Physical Status Classification I-II
- total knee arthroplasty
- 18-90 years
Who cannot join
- allergic to the local anesthetics
- cognitive impairment such as dementia
- coagulopathy
- motor and sensory impairment
- patient refusal
- BMI >39
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine, Yeungnam University hospital
Daegu, 705-035
Duckhee Lee, M.D., 82-53-620-3365, apsj0718@naver.com
Sangjin Park, M.D.
About this study
Official title: A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty
The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.
Read the detailed description
The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.
- Conditions
- Postoperative Pain
- Being tested
- epidural infusion, femoral sciatic
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural infusionProcedure or surgery
Also called continuous lumbar epidural block
Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
femoral sciaticProcedure or surgery
Also called femoral nerve block and sciatic nerve block
After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
epidural infusionDevice
Also called perifix epidural catheter, B-Braoun
Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
femoral sciaticDevice
Also called contiplex catheter and stimuplex needle; B-Braun
After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| epidural infusion | Experimental | In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation, Receives: Procedure: epidural infusion; Device: epidural infusion |
| femoral sciatic | Experimental | In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. Receives: Procedure: femoral sciatic; Device: femoral sciatic |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of side effects
Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.
Measured: during 5 days after the end of operation
Secondary outcomes (2)
Pain
Pain according to visual analogue scale at rest and on mobilization.
Measured: during 5 days after the end of operation
Motor blockade at rest and on mobilization
Motor blockade is estimated using a modified Bromage scale
Measured: during 5 days after the end of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangjin Park, Yeungnam University College of Medicine
- Investigators
- Sangjin Park, M.D., Principal investigator, Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235506
- Sponsor's protocol ID
- apsj0901
- Status last verified
- Jul 2015
- First submitted
- 1 Sep 2014
- Last updated
- 16 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Epidural Analgesia With Adding Sciatic Nerve Block to Continuous Femoral Nerve Block for Post-operative Pain Management Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02235506
- Acronym / sponsor ID
- apsj0901
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- 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.
The investigators compared continuous epidural infusion with combined continuous femoral and single-shot sciatic nerve blocks. The primary outcome was the incidence of side effects, and secondary outcomes were pain relief, motor blockade,morphine consumption, and rehabilitation indices.
Detailed description
The parcicipants were randomly assingned to epidural infusion group and femoral sciatic block. In epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation. In femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. The incidence of side effects is measured.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural infusion | Experimental | Procedure: epidural infusion, Device: epidural infusionIn epidural infusion group, a lumbar epidural catheter was placed at the L3-4 level using loss-ofresistance procedure. ropivacaine 0.2% and fentayl 2mcg/ml were infused at a rate of 5ml/hr from the end of operation, |
| femoral sciatic | Experimental | Procedure: femoral sciatic, Device: femoral sciaticIn femoral sciatic group, the femoral and sciatic nerve are located using ultrasound and 0.2% ropivacain is injected. A catheter is inserted to femoral nerve. From the end of operation, 0.2% ropivacaine was infused through the femoral catheter at a rate of 5ml/hr. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists Physical Status Classification I-II
- total knee arthroplasty
- 18-90 years
Key exclusion criteria (6 listed)
- allergic to the local anesthetics
- cognitive impairment such as dementia
- coagulopathy
- motor and sensory impairment
- patient refusal
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 infusionAlso: continuous lumbar epidural blockLumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr. | Procedure or surgery | epidural infusion |
| femoral sciaticAlso: femoral nerve block and sciatic nerve blockAfter femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery. | Procedure or surgery | femoral sciatic |
| epidural infusionAlso: perifix epidural catheter, B-BraounLumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr. | Device | epidural infusion |
| femoral sciaticAlso: contiplex catheter and stimuplex needle; B-BraunAfter femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery. | Device | femoral sciatic |
Primary outcome
the incidence of side effects
Time frame: during 5 days after the end of operation
Side effects: The patients were asked to their experience of dizziness, sedation, nausea/vomiting (PONV), and pruritus. Urinary retention: bladder volume was measured by ultrasonography and if the volume was more than 400 mL and if the patient was unable to void spontaneously, single catheterization was performed.
2 secondary outcomes
Pain
Time frame: during 5 days after the end of operation
Motor blockade at rest and on mobilization
Time frame: during 5 days after the end of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
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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.
Sangjin Park, M.D. principal investigator
Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea
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 infusion and femoral sciatic in people with Postoperative Pain, run by Yeungnam University College of Medicine 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 6 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: status not confirmed, as of the sponsor's last update on 16 Jul 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sangjin Park, M.D. (82-53-620-3366, apsj0718@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of side effects (time frame: during 5 days after the end of operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2015.