Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia

This study is currently recruiting participants.
Verified June 2013 by University Hospital, Antwerp
Sponsor:
Information provided by (Responsible Party):
Dr M. B. Breebaart, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01877356
First received: March 29, 2013
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Anesthesia; Adverse Effect, Spinal and Epidural
Procedure: bilateral spinal anesthesia
Procedure: unilateral spinal anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • time to micturition (minutes) [ Time Frame: up to 360 minutes ] [ Designated as safety issue: No ]
    time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)

  • discharge time ( minutes) [ Time Frame: up to 360 minutes ] [ Designated as safety issue: No ]
    time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge

  • regression motor block [ Time Frame: up to 240 minutes ] [ Designated as safety issue: No ]
    Motor block will be assessed at regular intervals from spinal injection (t0) until total regression of the motor block.


Secondary Outcome Measures:
  • drop blood pressure [ Time Frame: up to 240 minutes ] [ Designated as safety issue: Yes ]
    percentage drop blood pressure compared to baseline ( measured before spinal injection) Blood pressure will be measured at regular intervals from just prior to spinal injection until discharge

  • incidence transient neurologic symptoms [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    patients will be called at home one week postoperatively to ask for symptoms resembling transien neurological symptoms


Estimated Enrollment: 60
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bilateral spinal anesthesia
bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery
Procedure: bilateral spinal anesthesia
prilocaine plain 2% 50 mg
Experimental: unilateral spinal anesthesia
unilateral spinal anesthesia prilocaine hyperbaar 2% 25 mg ambulatory surgery
Procedure: unilateral spinal anesthesia
prilocaine 2% hyperbaric 25 mg

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
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • spinal anaesthesia
  • surgery<60 minutes

Exclusion Criteria:

  • preexisting micturition problems
  • surgery lower abdomen/pelvis
  • bmi>30
  • mental problems
  • kidney disease
  • neurologic disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01877356

Contacts
Contact: Margaretha breebaart, md 003238123865 margaretha.breebaart@uza.be
Contact: veerle verheyen, nurse 003238214405 veerle.verheyen@uza.be

Locations
Belgium
University Hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: margaretha breebaart, MD    003238213865    margaretha.breebaart@uza.be   
Contact: veerlev verheyen, studynurse    003238214405    veerle.verheyen@uza.be   
Principal Investigator: margaretha breebaart, md         
Principal Investigator: marcel Vercauteren, phd         
Sub-Investigator: stefan de wachter, phd         
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: margaretha breebaart, md senior member of staff department anaesthesiology
Study Director: Marcel Vercauteren, professor University Hospital, Antwerp
  More Information

Publications:
Responsible Party: Dr M. B. Breebaart, dr, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01877356     History of Changes
Other Study ID Numbers: study B300201215548, B300-2012-15-548
Study First Received: March 29, 2013
Last Updated: June 10, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Antwerp:
ambulatory surgery
spinal anesthesia
micturition
bladder retention
unilateral block
prilocaine hyperbaric
prilocaine plain
local anaesthetic dose

Additional relevant MeSH terms:
Anesthetics
Prilocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014