Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia
|ClinicalTrials.gov Identifier: NCT01877356|
Recruitment Status : Terminated (intermittent evaluation of results: high incendence of complications)
First Posted : June 13, 2013
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia; Adverse Effect, Spinal and Epidural||Procedure: bilateral spinal anesthesia Procedure: unilateral spinal anesthesia||Not Applicable|
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
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
- Micturition problems
- Use of per oral pain medication
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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
- 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)
- 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
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877356
|University Hospital Antwerp|
|Edegem, Antwerp, Belgium, 2650|
|Principal Investigator:||margaretha breebaart, md||senior member of staff department anaesthesiology|
|Study Director:||Marcel Vercauteren, professor||University Hospital, Antwerp|