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Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration

NCT ID: NCT01675895

Last Updated: 2012-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-07-31

Brief Summary

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The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.

Detailed Description

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A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).

Conditions

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Benign Prostate Hyperplasia

Keywords

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Hyperbaric Levobupivacaine İntrathecal Lidocaine TUR-P

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group Levobupivacaine lidocaine

Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine

Group Type EXPERIMENTAL

Levobupivacaine lidocaine spinal anesthesia

Intervention Type DRUG

Spinal anesthesia

Group Control

Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline

Group Type ACTIVE_COMPARATOR

levobupivacaine Spinal anesthesia

Intervention Type DRUG

spinal anesthesia

Interventions

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Levobupivacaine lidocaine spinal anesthesia

Spinal anesthesia

Intervention Type DRUG

levobupivacaine Spinal anesthesia

spinal anesthesia

Intervention Type DRUG

Other Intervention Names

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Chirocaine Lidocaine Chirocaine

Eligibility Criteria

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Inclusion Criteria

* elective transurethral resection of the prostate (TUR-P)

Exclusion Criteria

* patients with contraindications for spinal anesthesia,
* known sensitivity to the study drugs,
* emergency cases, and
* patients who refused spinal anaesthesia were excluded
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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DILEK YAZICIOGLU

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taylan Akkaya, MD

Role: STUDY_DIRECTOR

Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.

Locations

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Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.

Reference Type BACKGROUND
PMID: 18713891 (View on PubMed)

Other Identifiers

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DİLEKLEVOBUPİVACAİNE

Identifier Type: -

Identifier Source: org_study_id