Anesthesia; Adverse Effect, Spinal and EpiduralNCT01877356
Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia
A study testing bilateral spinal anesthesia and unilateral spinal anesthesia in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Anesthesia; Adverse Effect, Spinal and Epidural
- What is being tested?
- bilateral spinal anesthesia and unilateral spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- spinal anaesthesia
- surgery<60 minutes
Who cannot join
- preexisting micturition problems
- surgery lower abdomen/pelvis
- bmi>30
- mental problems
- kidney disease
- neurologic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- bilateral spinal anesthesia, unilateral spinal anesthesia
- Keywords
- ambulatory surgery, spinal anesthesia, micturition, bladder retention, unilateral block, prilocaine hyperbaric, prilocaine plain, local anaesthetic dose
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral spinal anesthesiaProcedure or surgery
prilocaine plain 2% 50 mg
unilateral spinal anesthesiaProcedure or surgery
prilocaine 2% hyperbaric 30 mg
| Study group | Role | What they receive |
|---|---|---|
| bilateral spinal anesthesia | Experimental | bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery Receives: Procedure: bilateral spinal anesthesia |
| unilateral spinal anesthesia | Experimental | unilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery Receives: Procedure: unilateral spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to micturition (minutes)
time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)
Measured: up to 360 minutes
discharge time ( minutes)
time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge
Measured: 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.
Measured: up to 240 minutes
Secondary outcomes (2)
drop blood pressure
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
Measured: up to 240 minutes
incidence transient neurologic symptoms
patients will be called at home one week postoperatively to ask for symptoms resembling transien neurological symptoms
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: intermittent evaluation of results: high incendence of complications
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse Effect, Spinal and EpiduralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr M. B. Breebaart, University Hospital, Antwerp
- Investigators
- margaretha breebaart, md, Principal investigator, senior member of staff department anaesthesiologyMarcel Vercauteren, professor, Study director, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877356
- Sponsor's protocol ID
- study B300201215548
- Other IDs
- B300-2012-15-548
- Status last verified
- Nov 2018
- First submitted
- 29 Mar 2013
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15024563Fanelli 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.
PubMed 10958090Akhtar 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.
PubMed 23217477Choi 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.
PubMed 22535232Kamphuis 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.
PubMed 9477049Breebaart 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.
PubMed 12594142
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time
- ClinicalTrials.gov ID
- NCT01877356
- Acronym / sponsor ID
- study B300201215548
- Keywords
- ambulatory surgery, spinal anesthesia, micturition, bladder retention, unilateral block, prilocaine hyperbaric, prilocaine plain, local anaesthetic dose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: intermittent evaluation of results: high incendence of complications
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bilateral spinal anesthesia | Experimental | Procedure: bilateral spinal anesthesiabilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery |
| unilateral spinal anesthesia | Experimental | Procedure: unilateral spinal anesthesiaunilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- spinal anaesthesia
- surgery<60 minutes
Key exclusion criteria (6 listed)
- preexisting micturition problems
- surgery lower abdomen/pelvis
- bmi>30
- mental problems
- kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral spinal anesthesiaprilocaine plain 2% 50 mg | Procedure or surgery | bilateral spinal anesthesia |
| unilateral spinal anesthesiaprilocaine 2% hyperbaric 30 mg | Procedure or surgery | unilateral spinal anesthesia |
Primary outcome
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.
2 secondary outcomes
drop blood pressure
Time frame: up to 240 minutes
incidence transient neurologic symptoms
Time frame: 1 week
Results and safety
The study was stopped early (reason given: intermittent evaluation of results: high incendence of complications). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Background: PubMed 15024563Esmaoglu 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.
- Background: PubMed 10958090Fanelli 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.
- Background: PubMed 23217477Akhtar 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.
- Background: PubMed 22535232Choi 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.
- Background: PubMed 9477049Kamphuis 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.
- Background: PubMed 12594142Breebaart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
margaretha breebaart, md principal investigator
senior member of staff department anaesthesiology
Marcel Vercauteren, professor study director
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bilateral spinal anesthesia and unilateral spinal anesthesia in people with Anesthesia; Adverse Effect, Spinal and Epidural, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: intermittent evaluation of results: high incendence of complications). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to micturition (minutes) (time frame: up to 360 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877356, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2018; AzTrials last refreshed its copy on 27 Oct 2026.