Comparative Study Between Bilateral and Unilateral Spinal Anaesthesia

NCT01877356 | Terminated DMC

• 2 other identifiers: study B300201215548B300-2012-15-548
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect, Spinal and Epidural

Keywords

ambulatory surgery; spinal anesthesia; micturition; bladder retention; unilateral block; prilocaine hyperbaric; prilocaine plain; local anaesthetic dose

Outcome Measures

Primary Outcomes (3)

• 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

• discharge time ( minutes)

  time from injection untill dischargecriteria are reached ( average of 4 hours). Time to event outcome , event = discharge

  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.

  up to 240 minutes

Secondary Outcomes (2)

• drop blood pressure

  up to 240 minutes

• incidence transient neurologic symptoms

  1 week

Study Arms (2)

bilateral spinal anesthesia

EXPERIMENTAL

bilateral spinal anesthesia prilocaine plain 20% 50 mg ambulatory surgery

Procedure: bilateral spinal anesthesia

unilateral spinal anesthesia

EXPERIMENTAL

unilateral spinal anesthesia prilocaine hyperbaar 2% 30 mg ambulatory surgery

Procedure: unilateral spinal anesthesia

Interventions

bilateral spinal anesthesia PROCEDURE

prilocaine plain 2% 50 mg

bilateral spinal anesthesia

unilateral spinal anesthesia PROCEDURE

prilocaine 2% hyperbaric 30 mg

unilateral spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• spinal anaesthesia
• surgery\<60 minutes

You may not qualify if:

• preexisting micturition problems
• surgery lower abdomen/pelvis
• bmi\>30
• mental problems
• kidney disease
• neurologic disease

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (6)

• 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.

  PMID: 15024563 BACKGROUND

• 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.

  PMID: 10958090 BACKGROUND

• 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.

  PMID: 23217477 BACKGROUND

• 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.

  PMID: 22535232 BACKGROUND

• 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.

  PMID: 9477049 BACKGROUND

• 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.

  PMID: 12594142 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• margaretha breebaart, md

  senior member of staff department anaesthesiology

  PRINCIPAL INVESTIGATOR

• Marcel Vercauteren, professor

  University Hospital, Antwerp

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: March 29, 2013
• First Posted: June 13, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

BE (1)