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Neurotoxicity of Spinal Anesthesia With Ropivacaine and Bupivacaine (BuRoNe)

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ClinicalTrials.gov Identifier: NCT03293472
Recruitment Status : Recruiting
First Posted : September 26, 2017
Last Update Posted : December 18, 2017
Sponsor:
Collaborator:
Department of Anesthesiology, Intensive Therapy, District Hospital No2 in Rzeszow
Information provided by (Responsible Party):
Marek Wojtaszek, University of Rzeszow

Brief 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 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.


Condition or disease Intervention/treatment Phase
Anesthesia; Adverse Effect, Spinal and Epidural Anaesthetic Complication Neurological Drug: Ropivacaine Drug: Bupivacaine Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel study
Masking: Single (Participant)
Masking Description: Patient unaware of the local anesthetic used.
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Experimental: Ropivacaine

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

Drug: Ropivacaine
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
Other Name: Ropimol

Active Comparator: Bupivacaine

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

Drug: Bupivacaine

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





Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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 selected mediators of inflammatory response (IL-1β, IL-6, tumor necrosis factor and others)

  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. [ Time Frame: 24 h ]
    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


Other Outcome Measures:
  1. Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the CSF of patients undergoing spinal anesthesia with ropivacaine and bupivacaine. [ Time Frame: 24 h ]
    Assessment of hemodynamic stability in patients anaesthetized with continuous epidural infusion of ropivacaine and bupivacaine

  2. Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the CSF of patients undergoing spinal anesthesia with ropivacaine and bupivacaine. [ Time Frame: 24h ]
    Postoperative pain severity in Numerical Rating Scale (NRS) in the first 24 hours after surgery [Time Frame: 24 h] NRS range from 0 for no pain to 10 for worst pain imaginable



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Orthopedic procedures in the lower limbs Written informed consent

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293472


Contacts
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Contact: Marek Wojtaszek, M.D., Ph.D. +48-17-872-1195 wojtaaszek@gmail.com
Contact: Bogumila Woloszczuk-Gebicka, M.D., Ph.D. +48-17-872-1195 gebicka@hotmail.com

Locations
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Poland
University of Rzeszow Recruiting
Rzeszów, Poland, 35310
Contact: Marek Wojtaszek, M.D.    +48-17-872-1195    wojtaaszek@gmail.com   
Contact: Bogumila Woloszczuk-Gebicka, M.D., Ph.D.    +48-17-872-1195    gebicka@hotmail.com   
Sponsors and Collaborators
University of Rzeszow
Department of Anesthesiology, Intensive Therapy, District Hospital No2 in Rzeszow

Publications of Results:
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Responsible Party: Marek Wojtaszek, M.D., Ph.D., University of Rzeszow
ClinicalTrials.gov Identifier: NCT03293472     History of Changes
Other Study ID Numbers: URzeszow
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Anesthetics
Bupivacaine
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents