AnesthesiaPhase 4NCT02084368
Application of Combined Lumbar Plexus and Sciatic Nerve Block
A Phase 4 study testing Nerve block, Combined spinal and epidural anesthesia and Ropivacaine in people with Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Nerve block, Combined spinal and epidural anesthesia and Ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Feb 2014
- Phase
- Phase 4
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
- Aged between 18 and 85 years
- Undergoing elective total knee replacement.
Who cannot join
- Mental illness can not match
- Nerve block, epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- History of chronic headaches and long-term use of analgesic drugs
- People who were postoperative consciousness, language or hearing impaired
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Military Region General Hospital, Department of Anesthesiology
Guangzhou, Guangdong, 510010
About this study
Official title: Application of Combined Lumbar Plexus and Sciatic Nerve Block in Unilateral Knee Replacement
The research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.
- Conditions
- Anesthesia
- Being tested
- Nerve block, Combined spinal and epidural anesthesia, Ropivacaine, Bupivacaine
- Keywords
- combined lumbar plexus and sciatic nerve block，, combined spinal and epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS
Combined spinal and epidural anesthesiaProcedure or surgery
Combined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8~10mg at L2-3 or L3-4.
RopivacaineDrug
Also called 0.33%Ropivacaine
Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.
BupivacaineDrug
Also called 0.5%Bupivacaine
Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg.
| Study group | Role | What they receive |
|---|---|---|
| Nerve block | Experimental | Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS. Receives: Procedure: Nerve block; Drug: Ropivacaine |
| combined spinal and epidural anesthesia | Placebo comparator | Combined spinal and epidural anesthesia were performed in patients of this group. Receives: Procedure: Combined spinal and epidural anesthesia; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance time of sensory and motor nerve block
from the end of injection of local anesthetic drug up to 24h after operation
Measured: up to 24h after operation
Secondary outcomes (1)
The change of hemodynamics
the changes of SBP and DBP at 0, 5, 10, 20, 30, 60 min after injection
Measured: 0, 5, 10, 20, 30, 60 min after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bo xu, Guangzhou General Hospital of Guangzhou Military Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084368
- Sponsor's protocol ID
- Nerve Block
- Status last verified
- Sep 2014
- First submitted
- 6 Mar 2014
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Farny J, Girard M, Drolet P. Posterior approach to the lumbar plexus combined with a sciatic nerve block using lidocaine. Can J Anaesth. 1994 Jun;41(6):486-91. doi: 10.1007/BF03011542.
PubMed 8069988de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14.
PubMed 21156977
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Combined Lumbar Plexus and Sciatic Nerve Block in Unilateral Knee Replacement
- ClinicalTrials.gov ID
- NCT02084368
- Acronym / sponsor ID
- Nerve Block
- Conditions
- Anesthesia
- Keywords
- combined lumbar plexus and sciatic nerve block，, combined spinal and epidural anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Mar 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 research is to study the effectiveness and safety of combined lumbar plexus and sciatic nerve block by the guide of peripheral nerve stimulator (PNS) in unilateral knee replacement.There have be some papers which supported that combined lumbar plexus and sciatic nerve block may be more suitable for the old men.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nerve block | Experimental | Procedure: Nerve block, Drug: RopivacainePatients in this group were assigned to receive lumbar plexus block and sciatic nerve block guided by PNS. |
| combined spinal and epidural anesthesia | Placebo comparator | Procedure: Combined spinal and epidural anesthesia, Drug: BupivacaineCombined spinal and epidural anesthesia were performed in patients of this group. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of American Association of anesthetists（ASA）Grade 1、2 or 3
- Aged between 18 and 85 years
- Undergoing elective total knee replacement.
Key exclusion criteria (5 listed)
- Mental illness can not match
- Nerve block, epidural anesthesia contraindicated
- People who have Slow-type arrhythmias
- History of chronic headaches and long-term use of analgesic drugs
- People who were postoperative consciousness, language or hearing impaired
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 |
|---|---|---|
| Nerve blockPatients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS | Procedure or surgery | Nerve block |
| Combined spinal and epidural anesthesiaCombined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8~10mg at L2-3 or L3-4. | Procedure or surgery | combined spinal and epidural anesthesia |
| RopivacaineAlso: 0.33%RopivacainePatients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS. | Drug | Nerve block |
| BupivacaineAlso: 0.5%BupivacaineCombined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg. | Drug | combined spinal and epidural anesthesia |
Primary outcome
Maintenance time of sensory and motor nerve block
Time frame: up to 24h after operation
from the end of injection of local anesthetic drug up to 24h after operation
1 secondary outcome
The change of hemodynamics
Time frame: 0, 5, 10, 20, 30, 60 min after injection
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 11 Sep 2014.
- Results publication: PubMed 8069988Farny J, Girard M, Drolet P. Posterior approach to the lumbar plexus combined with a sciatic nerve block using lidocaine. Can J Anaesth. 1994 Jun;41(6):486-91. doi: 10.1007/BF03011542.
- Results publication: PubMed 21156977de Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nerve block, Combined spinal and epidural anesthesia and Ropivacaine in people with Anesthesia, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
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 5 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 11 Sep 2014. 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 China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Maintenance time of sensory and motor nerve block (time frame: up to 24h after operation). 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 NCT02084368, which also lists 2 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 11 Sep 2014.