NCT03293472

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2017

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

2.1 years

First QC Date

September 21, 2017

Last Update Submit

December 14, 2017

Conditions

Anesthesia; Adverse Effect, Spinal and EpiduralAnaesthetic Complication Neurological

Outcome Measures

Primary Outcomes (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.

    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

    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.

    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.

    24 h

Other Outcomes (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.

    24 h

  • Inflammatory mediators, neural tissue injury markers and the markers of oxidative stress in the CSF of patients undergoing spinal anesthesia with ropivacaine and bupivacaine.

    24h

Study Arms (2)

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

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

Drug: Bupivacaine

Interventions

RopivacaineDRUG

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

Also known as: Ropimol
Ropivacaine
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

Bupivacaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Orthopedic procedures in the lower limbs Written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rzeszow

Rzeszów, 35310, Poland

RECRUITING

Related Publications (3)

  • Wille M. Intrathecal use of ropivacaine: a review. Acta Anaesthesiol Belg. 2004;55(3):251-9.

    PMID: 15515303RESULT

  • Kuthiala 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.

    PMID: 21712863RESULT

  • Sung 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.

    PMID: 25296645RESULT

MeSH Terms

Interventions

RopivacaineBupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Marek Wojtaszek, M.D., Ph.D.

CONTACT

+48-17-872-1195wojtaaszek@gmail.com

Bogumila Woloszczuk-Gebicka, M.D., Ph.D.

CONTACT

+48-17-872-1195gebicka@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patient unaware of the local anesthetic used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

December 1, 2017

Primary Completion

December 30, 2019

Study Completion

December 31, 2019

Last Updated

December 18, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)