Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia

Anesthesia; Adverse Effect, Spinal and Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01877356
• Other study ID #: study B300201215548
• Secondary ID: B300-2012-15-548
• Status: Terminated
• Phase: N/A
• Start date: December 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2018
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Our hypothesis is that unilateral spinal anesthesia will provide faster time to micturtition and discharge, lesser hypotension and lesser micturition problems.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• spinal anaesthesia

• surgery<60 minutes

Exclusion Criteria:

• preexisting micturition problems

• surgery lower abdomen/pelvis

• bmi>30

• mental problems

• kidney disease

• neurologic disease

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect, Spinal and Epidural

Intervention

Procedure:
• bilateral spinal anesthesia
prilocaine plain 2% 50 mg
• unilateral spinal anesthesia
prilocaine 2% hyperbaric 30 mg

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. doi: 12.2012/JCPSP.747750. — View 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. — View 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. Review. Erratum in: Can J Anaesth. 2017 Dec 18;:. — View 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. Epub 2003 Feb 22. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to micturition (minutes)	time to event outcome. Time from injection untill patient the moment voids for the first time (average off 4hours)	up to 360 minutes
Primary	discharge time ( minutes)	time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge	up to 360 minutes
Primary	regression motor block	Motor block will be assessed at regular intervals from spinal injection (t0) until total regression of the motor block.	up to 240 minutes
Secondary	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	up to 240 minutes
Secondary	incidence transient neurologic symptoms	patients will be called at home one week postoperatively to ask for symptoms resembling transien neurological symptoms	1 week