Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia

November 13, 2018 updated by: Dr M. B. Breebaart, University Hospital, Antwerp

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • spinal anaesthesia
  • surgery<60 minutes

Exclusion Criteria:

  • preexisting micturition problems
  • surgery lower abdomen/pelvis
  • bmi>30
  • mental problems
  • kidney disease
  • neurologic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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% 30 mg ambulatory surgery
Procedure: unilateral spinal anesthesia
prilocaine 2% hyperbaric 30 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
up to 360 minutes
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
up to 360 minutes
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.
up to 240 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
drop blood pressure
Time Frame: up to 240 minutes
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
up to 240 minutes
incidence transient neurologic symptoms
Time Frame: 1 week
patients will be called at home one week postoperatively to ask for symptoms resembling transien neurological symptoms
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: margaretha breebaart, md, senior member of staff department anaesthesiology
  • Study Director: Marcel Vercauteren, professor, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

March 29, 2013

First Submitted That Met QC Criteria

June 10, 2013

First Posted (ESTIMATE)

June 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 13, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • study B300201215548
  • B300-2012-15-548 (OTHER: BUN (belgisch uniek nummer))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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