Anesthesia; Adverse Effect, Spinal and EpiduralPhase 4BuRoNeNCT03293472
Neurotoxicity of Spinal Anesthesia With Ropivacaine and Bupivacaine
A Phase 4 study testing Ropivacaine and Bupivacaine in people with Anesthesia; Adverse Effect, Spinal and Epidural and Anaesthetic Complication Neurological, run by University of Rzeszow at 1 site in Poland.
Trial summary
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural, Anaesthetic Complication Neurological
- What is being tested?
- Ropivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2017to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orthopedic procedures in the lower limbs Written informed consent
Who cannot join
- Patients' refusal Known allergies to study medications Inability to comprehend or participate in pain scoring scale Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University of Rzeszow
Rzeszów, 35310
Marek Wojtaszek, M.D., +48-17-872-1195, wojtaaszek@gmail.com
Bogumila Woloszczuk-Gebicka, M.D., Ph.D., +48-17-872-1195, gebicka@hotmail.com
About this study
Official title: Inflammatory Mediators, Neural Tissue Injury Markers and the Markers of Oxidative Stress in the CSF of Patients Undergoing Spinal Anesthesia With Ropivacaine and Bupivacaine
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 hours postoperatively.
Primary Outcome Measures: Evaluation of changes in concentrations of glutamate in the cerebrospinal fluid and in the blood. Secondary outcomes: : Evaluation of changes in concentrations of selected mediators of inflammatory response (IL-1β, IL-6, TNF and others) and selected chemokines as markers of the glia damage.
Hemodynamic stability during the surgery, and efficacy of postoperative analgesia will be also evaluated.
Read the detailed description
With the approval from the Bioethical Committee of the University of Rzeszow, informed written consent will be obtained from all patients.
A sample size of 60 patients was calculated to obtain at least 25% reduction of glutamate concentration in the cerebrospinal fluid in the ropivacaine group with 0,05 significance and power of 0,8.
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly (1:1) assigned using closed envelopes to receive intrathecally ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 h for postoperative pain relief. All block will be performed in the sitting position, and the drug will be administered in supine position through the catheter in the intrathecal space. Blood and cerebrospinal fluid samples will be drawn at predetermined time intervals centrifuged as required and frosen in -70deg C until analysis.
Eligibility Ages eligible for study 18 years and older (Adult, Senior) Sexes Eligible for the Study: All Accepts Healthy Volunteers: No
Inclusion Criteria:
Orthopedic procedures in the lower limbs Written informed consent Exclusion criteria Patients' refusal Known allergies to study medications Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.
Inability to comprehend or participate in pain scoring scale
- Being tested
- Ropivacaine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Ropimol
Procedure: Continuous Epidural Anesthesia Local anesthetic injection to the cerebrospinal fluid (subarachnoid space) at the L3-L4 or L4-L5 level Drug: ropivacaine Other name: Ropimol 0.5% ropivacaine (isobaric) 4.5 ml for the patients < 160 cm tall, 5.0 ml for 161-170 cm tall, 5.5 ml for 171-180 cm tall, and 6.0 ml > 180 cm, supplementary ropivacaine bolus doses as required, followed by 0.2% ropivacaine, 1 ml/h for the postoperative period Device : The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6" 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle
BupivacaineDrug
Procedure: Continuous Epidural Anesthesia Local anesthetic injection to the subarachnoid space at the L3-L4 or L4-L5 level Drug: bupivacaine Loading dose of bupivacaine followed by 0.12% bupivacaine, 1 ml/h Other name: bupivacaine
Device:
The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6" 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Experimental | Experimental: 0.5% ropivacaine (isobaric) 4.5 ml for the patients < 160 cm tall, 5.0 ml for 161-170 cm tall, 5.5 ml for 171-180 cm tall, and 6.0 ml > 180 cm.
supplementary bolus doses of ropivacaine as required, followed by 0.2% ropivacaine, 1 ml/h for the postoperative period Receives: Drug: Ropivacaine |
| Bupivacaine | Active comparator | 0.5% v Bupivacaine mg (isobaric) loading dose of 0.5% bupivacaine, 3.0 ml for the patients < 160 cm tall, 3.3 ml for 161-170 cm tall, 3.6 ml for 171-180 cm tall, and 4.0 ml > 180 cm.
and supplementary bupivacaine bolus dose as required, followed by 0,12% bupivacaine 1 ml/h for the postoperative period Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Evaluation of changes in concentrations of
- glutamate in the cerebrospinal fluid and in the blood of patients undergoing orthopaedic surgery under spinal anesthesia with either ropivacaine or bupivacaine
Measured: 24 h
Secondary outcomes (2)
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Evaluation of changes in concentrations of selected mediators of inflammatory response (IL-1β, IL-6, tumor necrosis factor and others)
Measured: 24 h
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Evaluation of changes in concentrations of • selected chemokines as markers of the glia damage in the cerebrospinal fluid and in the blood of patients undergoing orthopaedic surgery under continuous spinal anesthesia with either ropivacaine or bupivacaine
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Dec 2017
- Primary completion30 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies 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
- Model description
- Parallel study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology, Intensive Therapy, District Hospital No2 in Rzeszow
- Responsible party
- Principal investigator, Marek Wojtaszek, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293472
- Sponsor's protocol ID
- URzeszow
- Acronym
- BuRoNe
- Status last verified
- Dec 2017
- First submitted
- 21 Sep 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wille M. Intrathecal use of ropivacaine: a review. Acta Anaesthesiol Belg. 2004;55(3):251-9.
PubMed 15515303Kuthiala G, Chaudhary G. Ropivacaine: A review of its pharmacology and clinical use. Indian J Anaesth. 2011 Mar;55(2):104-10. doi: 10.4103/0019-5049.79875.
PubMed 21712863Sung CM, Hah YS, Kim JS, Nam JB, Kim RJ, Lee SJ, Park HB. Cytotoxic effects of ropivacaine, bupivacaine, and lidocaine on rotator cuff tenofibroblasts. Am J Sports Med. 2014 Dec;42(12):2888-96. doi: 10.1177/0363546514550991. Epub 2014 Oct 8.
PubMed 25296645
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Mediators, Neural Tissue Injury Markers and the Markers of Oxidative Stress in the CSF of Patients Undergoing Spinal Anesthesia With Ropivacaine and Bupivacaine
- ClinicalTrials.gov ID
- NCT03293472
- Acronym / sponsor ID
- BuRoNe / URzeszow
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Collaborators
- Department of Anesthesiology, Intensive Therapy, District Hospital No2 in Rzeszow
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 26 Sep 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.
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly assigned (1:1) to receive ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 hours postoperatively.
Primary Outcome Measures: Evaluation of changes in concentrations of glutamate in the cerebrospinal fluid and in the blood. Secondary outcomes: : Evaluation of changes in concentrations of selected mediators of inflammatory response (IL-1β, IL-6, TNF and others) and selected chemokines as markers of the glia damage.
Hemodynamic stability during the surgery, and efficacy of postoperative analgesia will be also evaluated.
Detailed description
With the approval from the Bioethical Committee of the University of Rzeszow, informed written consent will be obtained from all patients.
A sample size of 60 patients was calculated to obtain at least 25% reduction of glutamate concentration in the cerebrospinal fluid in the ropivacaine group with 0,05 significance and power of 0,8.
Consenting patients, scheduled for orthopaedic surgery under spinal anesthesia will be randomly (1:1) assigned using closed envelopes to receive intrathecally ropivacaine or bupivacaine as a single shot before the start of surgery, followed by bolus doses of the same local anesthetic as required during the surgery, and continuous infusion of the same local anesthetic for 24 h for postoperative pain relief. All block will be performed in the sitting position, and the drug will be administered in supine position through the catheter in the intrathecal space. Blood and cerebrospinal fluid samples will be drawn at predetermined time intervals centrifuged as required and frosen in -70deg C until analysis.
Eligibility Ages eligible for study 18 years and older (Adult, Senior) Sexes Eligible for the Study: All Accepts Healthy Volunteers: No
Inclusion Criteria:
Orthopedic procedures in the lower limbs Written informed consent Exclusion criteria Patients' refusal Known allergies to study medications Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.
Inability to comprehend or participate in pain scoring scale
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel study
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Experimental | Drug: RopivacaineExperimental: 0.5% ropivacaine (isobaric) 4.5 ml for the patients < 160 cm tall, 5.0 ml for 161-170 cm tall, 5.5 ml for 171-180 cm tall, and 6.0 ml > 180 cm. supplementary bolus doses of ropivacaine as required, followed by 0.2% ropivacaine, 1 ml/h for the postoperative period |
| Bupivacaine | Active comparator | Drug: Bupivacaine0.5% v Bupivacaine mg (isobaric) loading dose of 0.5% bupivacaine, 3.0 ml for the patients < 160 cm tall, 3.3 ml for 161-170 cm tall, 3.6 ml for 171-180 cm tall, and 4.0 ml > 180 cm. and supplementary bupivacaine bolus dose as required, followed by 0,12% bupivacaine 1 ml/h for the postoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Orthopedic procedures in the lower limbs Written informed consent
Key exclusion criteria (1 listed)
- Patients' refusal Known allergies to study medications Inability to comprehend or participate in pain scoring scale Anatomic, posttraumatic and postoperative deformations of the spinal column making placement of intrathecal catheter impossible Neurological contraindications Any other contraindications for spinal anesthesia (coagulations disorders, antiplatelet or anticoagulant treatment, infection at the puncture site.
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 |
|---|---|---|
| RopivacaineAlso: RopimolProcedure: Continuous Epidural Anesthesia Local anesthetic injection to the cerebrospinal fluid (subarachnoid space) at the L3-L4 or L4-L5 level Drug: ropivacaine Other name: Ropimol 0.5% ropivacaine (isobaric) 4.5 ml for the patients < 160 cm tall, 5.0 ml for 161-170 cm tall, 5.5 ml for 171-180 cm tall, and 6.0 ml > 180 cm, supplementary ropivacaine bolus doses as required, followed by 0.2% ropivacaine, 1 ml/h for the postoperative period Device : The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6" 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle | Drug | Ropivacaine |
| BupivacaineProcedure: Continuous Epidural Anesthesia Local anesthetic injection to the subarachnoid space at the L3-L4 or L4-L5 level Drug: bupivacaine Loading dose of bupivacaine followed by 0.12% bupivacaine, 1 ml/h Other name: bupivacaine Device: The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6" 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle | Drug | Bupivacaine |
Primary outcome
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Time frame: 24 h
Evaluation of changes in concentrations of • glutamate in the cerebrospinal fluid and in the blood of patients undergoing orthopaedic surgery under spinal anesthesia with either ropivacaine or bupivacaine
2 secondary outcomes
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Time frame: 24 h
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.
Time frame: 24 h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2017.
- Results publication: PubMed 15515303Wille M. Intrathecal use of ropivacaine: a review. Acta Anaesthesiol Belg. 2004;55(3):251-9.
- Results publication: PubMed 21712863Kuthiala G, Chaudhary G. Ropivacaine: A review of its pharmacology and clinical use. Indian J Anaesth. 2011 Mar;55(2):104-10. doi: 10.4103/0019-5049.79875.
- Results publication: PubMed 25296645Sung CM, Hah YS, Kim JS, Nam JB, Kim RJ, Lee SJ, Park HB. Cytotoxic effects of ropivacaine, bupivacaine, and lidocaine on rotator cuff tenofibroblasts. Am J Sports Med. 2014 Dec;42(12):2888-96. doi: 10.1177/0363546514550991. Epub 2014 Oct 8.
- Individual participant dataSharing planned: No
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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.
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 Anesthesia; Adverse Effect, Spinal and Epidural and Anaesthetic Complication Neurological, run by University of Rzeszow at 1 site in Poland.
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 1 inclusion and 1 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 18 Dec 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marek Wojtaszek, M.D., Ph.D. (+48-17-872-1195, wojtaaszek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the cerebrospinal fluid of patients undergoing spinal anesthesia with ropivacaine and bupivacaine. (time frame: 24 h). 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 NCT03293472, which also lists 3 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 Dec 2017.