intermittent evaluation of results: high incendence of complications
Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time
Sponsor study identifier
Secondary identifiers
OTHER · BUN (belgisch uniek nummer)
interventional
25
1 country
1
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)The purpose of this study is to compare unilateral spinal anesthesia using hyperbaric Prilocaine with "classical bilateral spinal anesthesia" using plain Prilocaine according to block characteristics and quality of micturition, standardized to the subjects own functional bladder capacity. Our hypothesis is that unilateral spinal anesthesia will provide faster time to micturtition and discharge, lesser hypotension and lesser micturition problems.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
March 29, 2013
Actual (reported)June 13, 2013
Actual (reported)August 2014
Actual (reported)August 2014
Actual (reported)time to micturition (minutes)
time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)
up to 360 minutes
discharge time ( minutes)
time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge
up to 360 minutes
regression motor block
Motor block will be assessed at regular intervals from spinal injection (t0) until total regression of the motor block.
up to 240 minutes
drop blood pressure
up to 240 minutes
incidence transient neurologic symptoms
1 week
bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery
unilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery
prilocaine plain 2% 50 mg
prilocaine 2% hyperbaric 30 mg
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital Antwerp
Edegem, Antwerp, 2650, Belgium
Esmaoglu A, Karaoglu S, Mizrak A, Boyaci A. Bilateral vs. unilateral spinal anesthesia for outpatient knee arthroscopies. Knee Surg Sports Traumatol Arthrosc. 2004 Mar;12(2):155-8. doi: 10.1007/s00167-003-0350-2. Epub 2003 Feb 22.
Fanelli G, Borghi B, Casati A, Bertini L, Montebugnoli M, Torri G. Unilateral bupivacaine spinal anesthesia for outpatient knee arthroscopy. Italian Study Group on Unilateral Spinal Anesthesia. Can J Anaesth. 2000 Aug;47(8):746-51. doi: 10.1007/BF03019476.
margaretha breebaart, md
senior member of staff department anaesthesiology
Marcel Vercauteren, professor
University Hospital, Antwerp
25 participants (actual enrollment reported by the registry).
First Submitted
March 29, 2013
First Posted
June 13, 2013
Study Start
December 2012
Date type not reportedThis date has not been verified as actual or estimated.
Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?
Contact the study team to confirm eligibility.
Akhtar MN, Tariq S, Abbas N, Murtaza G, Nadeem Naqvi SM. Comparison of haemodynamic changes in patients undergoing unilateral and bilateral spinal anaesthesia. J Coll Physicians Surg Pak. 2012 Dec;22(12):747-50.
Choi S, Mahon P, Awad IT. Neuraxial anesthesia and bladder dysfunction in the perioperative period: a systematic review. Can J Anaesth. 2012 Jul;59(7):681-703. doi: 10.1007/s12630-012-9717-5. Epub 2012 Apr 26.
Kamphuis ET, Ionescu TI, Kuipers PW, de Gier J, van Venrooij GE, Boon TA. Recovery of storage and emptying functions of the urinary bladder after spinal anesthesia with lidocaine and with bupivacaine in men. Anesthesiology. 1998 Feb;88(2):310-6. doi: 10.1097/00000542-199802000-00007.
Breebaart MB, Vercauteren MP, Hoffmann VL, Adriaensen HA. Urinary bladder scanning after day-case arthroscopy under spinal anaesthesia: comparison between lidocaine, ropivacaine, and levobupivacaine. Br J Anaesth. 2003 Mar;90(3):309-13. doi: 10.1093/bja/aeg078.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
November 14, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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