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Clinical Trials/NCT01877356
NCT01877356
Terminated
Not Applicable

Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time

University Hospital, Antwerp1 site in 1 country25 target enrollmentDecember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia; Adverse Effect, Spinal and Epidural
Sponsor
University Hospital, Antwerp
Enrollment
25
Locations
1
Primary Endpoint
time to micturition (minutes)
Status
Terminated
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

Many studies have been published in search of the ideal locoregional anesthetic for day case procedures under spinal anesthesia. Transient neurological symptoms (TNS) and bladder retention are two side effects, which have been described in literature with incidences ranging from 0-80%. Lidocaine, which was our hospital standard for spinal anesthesia in day case surgery, has a high incidence of TNS. Besides changing the product, dose or additive, optimisation of spinal anesthesia can be performed by changing anesthetic technique or fluid policy. There is no consensus in literature about fluid policy and the risk of urinary retention. In a previous study we found that urge sensation and bladder capacity is subject to a high variability. There are a few studies published about unilateral anesthesia for day-case surgery. For bilateral anesthesia it was shown that recuperation of the detrusor function comes with the regression of the sensory block to the S2 dermatome . However, little is known about bladder function during unilateral block of the sacral segments, not to mention the detrusor function and micturition with an asymmetric recovery of the sensory and motor block. Prilocaine has found to induce reasonably short durations of spinal blockade, without causing TNS while manufactured in plain and hyperbaric solutions . We expect that with a unilateral technique patients can void faster and can reach discharge criteria faster then with a bilateral technique. We will compare unilateral spinal anesthesia with hyperbaric prilocaine with bilateral spinal anesthesia with plain prilocaine. The two techniques will be compared on the following subject * quality of the motor and sensory block * recovery from the sensory and motor block * hemoynamic changens (blood pressure and hart rate) * time to micturition * micturition quality * discharge time * complications Sensory block will be tested by loss of cold sensation. Quality of unilateral block will be tested by QST. Protocol for catheterisation will be adjusted according to the patients individual bladder capacitity, based on a bladder diary. Quality of micturition will be based on bladderscanning, uroflow and subjective complaints. A micturition score from one of our previous studies is used. Two days and one week postoperative patients will be called and asked if they experienced one of the following symptoms: * Back pain * Symptoms of TNS * Headache * Micturition problems * Use of per oral pain medication * Other

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
August 2014
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr M. B. Breebaart

dr

University Hospital, Antwerp

Eligibility Criteria

Inclusion Criteria

  • spinal anaesthesia
  • surgery\<60 minutes

Exclusion Criteria

  • preexisting micturition problems
  • surgery lower abdomen/pelvis
  • mental problems
  • kidney disease
  • neurologic disease

Outcomes

Primary Outcomes

time to micturition (minutes)

Time Frame: up to 360 minutes

time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)

regression motor block

Time Frame: up to 240 minutes

Motor block will be assessed at regular intervals from spinal injection (t0) until total regression of the motor block.

discharge time ( minutes)

Time Frame: up to 360 minutes

time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge

Secondary Outcomes

  • drop blood pressure(up to 240 minutes)
  • incidence transient neurologic symptoms(1 week)

Study Sites (1)

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