Total Hip ReplacementPhase 4NCT02544269
Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia
A Phase 4 study testing Ropivacaine and Bupivacaine in people with Total Hip Replacement, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Ropivacaine and Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jun 2016to 25 Jan 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for total hip replacement at Aarhus University Hospital
- Age >= 50 years
- American Society of Anesthesiologists physical status classification score I-III
- Informed consent
Who cannot join
- Lack of ability to cooperate
- Lack of ability to speak Danish
- Chronic pain, that demands opioid treatment. Not inkl. hip pain.
- Previous venous thromboembolic event
- Previous major back surgery
- Severe cardiopulmonary disease (NYHA class 4)
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- Severe untreated hypertension (systolic blood pressure > 160 mm Hg or diastolic blood pressure > 110 mm Hg)
- Obesity (BMI > 35 kg/m^2)
- Pregnancy
- Allergy towards the used local analgetics
- Current treatment with amiodarone or verapamil
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.
Read the detailed description
Patients for total hip replacement will be randomized for surgical anesthesia with either lumbosacral plexus blockade or continuous spinal anesthesia. All patients will receive central venous, arterial and spinal catheters. Hemodynamics will be monitored with transpulmonary thermodilution and pulse contour analysis. Perineural injection of study medicine around the lumbar and sacral plexus will be performed guided by ultrasound and nerve stimulation. Study medicine will be injected in divided doses in the spinal catheter. Treatment will be blinded using double-dummy technique. After the first intrathecal dose of study medicine, the hemodynamic response will be monitored for 60 minutes. Patients will then be transferred to the operating room, where total hip replacement will be performed in lumbosacral plexus blockade or spinal anesthesia according to randomization.
- Conditions
- Total Hip Replacement
- Being tested
- Ropivacaine, Bupivacaine
- Keywords
- Lumbosacral plexus blockade, Continuous spinal anesthesia, Hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineProcedure or surgery
Lumbosacral plexus blockade with ropivacaine.
BupivacaineProcedure or surgery
Regional anesthesia with bupivacaine titrated to the lowest effective dose
| Study group | Role | What they receive |
|---|---|---|
| Lumbosacral plexus blockade | Experimental | Peripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural Receives: Procedure: Ropivacaine |
| Continuous spinal anesthesia | Active comparator | Continuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal Receives: Procedure: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of cardiac output
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Measured: Up to 1 hour
Secondary outcomes (14)
Time for performance of nerve blocks
Time range (in minutes) from first insertion to last withdrawal of nerve block needle.
Measured: At time of nerve block performance
Success rate of nerve blocks
Measured: 1 day
Change of cardiac stroke volume
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Measured: Up to 1 hour
Change of systemic vascular resistance
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Measured: Up to 1 hour
Change of mean arterial pressure
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Measured: Up to 1 hour
Change of central venous oxygen saturation
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
Measured: Up to 1 hour
Maximum plasma concentration of ropivacaine
Arterial blood sampling at 20, 40, 60 and 80 minutes after 1st dose of intrathecal study medicine.
Measured: 80 minutes
Change of plasma concentration of lactate
Arterial blood sampling at 0, 30 and 60 minutes after 1st dose of intrathecal study medicine.
Measured: 60 minutes
Cumulated peroperative propofol dose
Measured: Up to 2 hours
Cumulated peroperative opioid dose
Measured: Up to 2 hours
Cumulated postoperative opioid dose
Measured: Up to 24 hours
Time from end of operation to first opioid dose
Measured: Up to 24 hours
Surgeons self reported satisfaction with anesthesia
Numeric rating scale: 0-10
Measured: Up to 2 hours
Patients worst pain during surgery
Numeric rating scale: 0-10
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study start1 Jun 2016
- Primary completion25 Jan 2017
- Study completion25 Jan 2017
Why it stopped: After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Responsible party
- Sponsor
- Investigators
- Niels D Nielsen, MD, Principal investigator, Aarhus University, Dept. of Clinical MedicineThomas F Bendtsen, MD, PhD, Study director, Aarhus University Hospital, Dept. of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544269
- Sponsor's protocol ID
- HIP/FUSION#1
- Other IDs
- 2015-003498-13, 2015
- Status last verified
- Mar 2016
- First submitted
- 1 Sep 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized data will be made available through Danish Data Archive.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Anesthesia for Elective Hip Surgery - Hemodynamic Effect of Lumbosacral Plexus Blockade Compared to Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02544269
- Acronym / sponsor ID
- HIP/FUSION#1
- Conditions
- Total Hip Replacement
- Keywords
- Lumbosacral plexus blockade, Continuous spinal anesthesia, Hemodynamics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Silkeborg
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 25 Jan 2017 (actual)
- Study completion
- 25 Jan 2017 (actual)
- First posted
- 9 Sep 2015 (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 study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.
Detailed description
Patients for total hip replacement will be randomized for surgical anesthesia with either lumbosacral plexus blockade or continuous spinal anesthesia. All patients will receive central venous, arterial and spinal catheters. Hemodynamics will be monitored with transpulmonary thermodilution and pulse contour analysis. Perineural injection of study medicine around the lumbar and sacral plexus will be performed guided by ultrasound and nerve stimulation. Study medicine will be injected in divided doses in the spinal catheter. Treatment will be blinded using double-dummy technique. After the first intrathecal dose of study medicine, the hemodynamic response will be monitored for 60 minutes. Patients will then be transferred to the operating room, where total hip replacement will be performed in lumbosacral plexus blockade or spinal anesthesia according to randomization.
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 |
|---|---|---|
| Lumbosacral plexus blockade | Experimental | Procedure: RopivacainePeripheral nerve blockade of lumbar and sacral plexus with ropivacaine max 225 mg perineural |
| Continuous spinal anesthesia | Active comparator | Procedure: BupivacaineContinuous spinal anesthesia with plain bupivacaine max 15 mg intrathecal |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients for total hip replacement at Aarhus University Hospital
- Age >= 50 years
- American Society of Anesthesiologists physical status classification score I-III
- Informed consent
Key exclusion criteria (11 listed)
- Lack of ability to cooperate
- Lack of ability to speak Danish
- Chronic pain, that demands opioid treatment. Not inkl. hip pain.
- Previous venous thromboembolic event
- Previous major back surgery
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 |
|---|---|---|
| RopivacaineLumbosacral plexus blockade with ropivacaine. | Procedure or surgery | Lumbosacral plexus blockade |
| BupivacaineRegional anesthesia with bupivacaine titrated to the lowest effective dose | Procedure or surgery | Continuous spinal anesthesia |
Primary outcome
Change of cardiac output
Time frame: Up to 1 hour
Change from baseline (before nerve block performance) to 30 minutes after 1st dose of intrathecal study medicine.
14 secondary outcomes
Time for performance of nerve blocks
Time frame: At time of nerve block performance
Success rate of nerve blocks
Time frame: 1 day
Change of cardiac stroke volume
Time frame: Up to 1 hour
Change of systemic vascular resistance
Time frame: Up to 1 hour
Change of mean arterial pressure
Time frame: Up to 1 hour
Change of central venous oxygen saturation
Time frame: Up to 1 hour
Maximum plasma concentration of ropivacaine
Time frame: 80 minutes
Change of plasma concentration of lactate
Time frame: 60 minutes
Cumulated peroperative propofol dose
Time frame: Up to 2 hours
Cumulated peroperative opioid dose
Time frame: Up to 2 hours
Cumulated postoperative opioid dose
Time frame: Up to 24 hours
Time from end of operation to first opioid dose
Time frame: Up to 24 hours
Surgeons self reported satisfaction with anesthesia
Time frame: Up to 2 hours
Patients worst pain during surgery
Time frame: Up to 2 hours
Results and safety
The study was stopped early (reason given: After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available through Danish Data Archive.
Related trials for Total Hip Replacement
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
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PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
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Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
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Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
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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.
Niels D Nielsen, MD principal investigator
Aarhus University, Dept. of Clinical Medicine
Thomas F Bendtsen, MD, PhD study director
Aarhus University Hospital, Dept. of Anesthesiology
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 Ropivacaine and Bupivacaine in people with Total Hip Replacement, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 5 May 2017. 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 Denmark. 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.
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 was stopped early (reason given: After pilot study no difference in the primary end point was found between the two primary. Non-inferiority trial not deemed feasible.). Results are not available in the source record.
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?
Change of cardiac output (time frame: Up to 1 hour). 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 5 May 2017.