Clinical trial NCT01877356: Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia
Official title: Unilateral Versus Bilateral Spinal Anesthesia in Day Case Procedures: Difference in Block Characteristics, Micturition Quality and Discharge Time
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia; Adverse Effect, Spinal and Epidural
Keywords: ambulatory surgery
spinal anesthesia
micturition
bladder retention
unilateral block
prilocaine hyperbaric
prilocaine plain
local anaesthetic dose
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2013-06-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: time to micturition (minutes)
timeFrame: up to 360 minutes
measure: discharge time ( minutes)
timeFrame: up to 360 minutes
measure: regression motor block
timeFrame: up to 240 minutes
Secondary outcomes:
measure: drop blood pressure
timeFrame: up to 240 minutes
measure: incidence transient neurologic symptoms
timeFrame: 1 week
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: senior member of staff department anaesthesiology
name: margaretha breebaart, md
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Marcel Vercauteren, professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Fanelli 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.
citation: Akhtar 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.
citation: Choi 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.
citation: Kamphuis 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.
citation: Breebaart 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.