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Comparisson of two epidural drugs in day-case surgery


- candidate number28139
- NTR NumberNTR6796
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-nov-2017
- Secondary IDsNL53492.029.15 2016-06
- Public TitleComparisson of two epidural drugs in day-case surgery
- Scientific TitleChloroprocaine vs. prilocaine for spinal anaesthesia in day-case surgery: a double-blind randomized trial
- ACRONYMSPACE
- hypothesisThe null hypothesis is that there is no significant intergroup difference in time to complete recovery from motor blockade.
- Healt Condition(s) or Problem(s) studiedKnee arthroplasty, Prilocaine, Chloroprocaine
- Inclusion criteria- Scheduled ambulatory knee arthroscopy
- Age > 18 years
- ASA physical status I- II14
- Exclusion criteria- Allergy to one of the trial drugs
- Contraindication to neuraxial anaesthesia
- Previous neuropathy to the lower extremities
- Pregnancy
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 25-nov-2016
- planned closingdate1-aug-2018
- Target number of participants150
- InterventionsPatients receive intrathecally 40 mg plain chloroprocaine or 40 mg hyperbaric prilocaine.
- Primary outcomethe time to complete motor block recovery.
- Secondary outcomeurine retention needing catheterisation, Transient Neurologic Syndrom (TNS), time to ambulation and patient satisfaction.
- TimepointsConcerning the sensory block, ice cubes are used at 2, 4, 6, 8, 10, 15, 20, 25 and 30 min, and then at 15-min intervals until the sensory blockade had regressed tot dermatome S2. Motor blockade is evaluated at 5, 10, 15, 20, 25, 30, 45, 60, 75 and 90 min and then every 15 min until the ‘healthy’ leg can be fully elevated.
The urinary bladder will be examined by ultra-sound 30 min postoperative.
At day 1 and 7 postoperatively
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Elsbeth Wesselink
- CONTACT for SCIENTIFIC QUERIES Elsbeth Wesselink
- Sponsor/Initiator Zaans Medisch Centrum
- Funding
(Source(s) of Monetary or Material Support)
Zaans Medisch Centrum
- Publications
- Brief summaryIn day-case surgery, spinal anaesthesia with both rapid onset and a short duration of block is preferred. For this purpose, lidocaine has been the drug of choice for decades but has been associated with an unacceptable number (20-30%) of transient neurologic symptoms (TNSs). In recent years, chloroprocaine (CP) and prilocaine (P) have gained interest as short-acting spinal anaesthetics seemingly without the issue of urinary retention or TNSs. So far, these drugs have not been compared as to whether one would be more preferable than the other in an ambulant setting.
- Main changes (audit trail)
- RECORD3-nov-2017 - 23-nov-2017


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