Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia

NCT ID: NCT01877356

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-08-31

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

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bilateral spinal anesthesia

bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery

Group Type: EXPERIMENTAL

bilateral spinal anesthesia

Intervention Type: PROCEDURE

prilocaine plain 2% 50 mg

unilateral spinal anesthesia

unilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery

Group Type: EXPERIMENTAL

unilateral spinal anesthesia

Intervention Type: PROCEDURE

prilocaine 2% hyperbaric 30 mg

Interventions

bilateral spinal anesthesia

prilocaine plain 2% 50 mg

Intervention Type: PROCEDURE

unilateral spinal anesthesia

prilocaine 2% hyperbaric 30 mg

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Dr M. B. Breebaart

dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

margaretha breebaart, md

Role: PRINCIPAL_INVESTIGATOR

senior member of staff department anaesthesiology

Marcel Vercauteren, professor

Role: STUDY_DIRECTOR

University Hospital, Antwerp

Locations

University Hospital Antwerp

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 15024563 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10958090 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23217477 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22535232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9477049 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12594142 (View on PubMed)

Other Identifiers

B300-2012-15-548

Identifier Type: OTHER

Identifier Source: secondary_id

study B300201215548

Identifier Type: -

Identifier Source: org_study_id