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Optimale dosering voor een ruggenprik bij kortdurende operaties.


- candidate number28215
- NTR NumberNTR6946
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-nov-2017
- Secondary IDs2018.026 VUMC
- Public TitleOptimale dosering voor een ruggenprik bij kortdurende operaties.
- Scientific TitleED50 and ED90 of intrathecal 1% chloroprocaine in day-case knee arthroscopy
- ACRONYMCORONA
- hypothesisWe will establish the optimal dose chloroprocaine for knee-arthroscopy
- Healt Condition(s) or Problem(s) studiedSpinal anesthesia, Knee arthroplasty
- Inclusion criteria• Scheduled elective ambulatory knee arthroscopy
• Age >18 years
• American Society of Anesthesiology physical status I- III
- Exclusion criteria• Allergy to one of the trial drugs
• Contraindication to neuraxial anesthesia
• Previous neuropathy to the lower extremities
• Pregnancy
• No informed consent
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-feb-2018
- planned closingdate1-feb-2019
- Target number of participants90
- Interventions• In the first part of the study, the injected dose of chloroprocaine will be varied according to the modified up-and-down sequential allocation method (UDM) established by Dixon and Massey.14,15 The dose of chloroprocaine that a patient receives is determined by the previous patient’s response. If successful anesthesia was obtained, the next dose will be decreased. Conversely, if anesthesia was not successful, the next dose is increased. Treatment allocation will take place one day before hospital admission.
• In the second part of the study, all patients receive the ED90 dose determined in the first part. This observational section is performed with a chosen sample of patients scheduled for the same type of surgery.
- Primary outcomeSuccesfull anesthesia. Anesthesia is considered successful when:
1. Complete loss of cold sensation at the L2 dermatome, AND
2. Pain is 0-2 following inflation of the tourniquet and zero upon incision
3. Pain is 0-3 during surgery
- Secondary outcome- Motor block
- TNS
- Urine retention
- Patient satisfaction
- TimepointsSensibel block at t=2, 4, 6, 8, 10, 15, 20, 25, 30 until end of recovery
Motor block at t=5, 10, 15, 20, 25, 30, 45, 60
Pain score at inflation of the tourniquet and during surgery
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Elsbeth Wesselink
- CONTACT for SCIENTIFIC QUERIES Elsbeth Wesselink
- Sponsor/Initiator VUmc
- Funding
(Source(s) of Monetary or Material Support)
Gerrit Blaauw Fonds
- Publications
- Brief summaryIn day-case surgery, spinal anesthesia with both rapid onset, a short duration of block and minimal side effects is preferred. Chloroprocaine (CP) is increasingly used for this purpose. So far, the optimal dose of chloroprocaine has not been clinically established for ambulatory knee arthroscopy regarding quick postoperative mobilization and patient comfort.
- Main changes (audit trail)
- RECORD16-nov-2017 - 26-jan-2018


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