Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
1 other identifier
interventional
40
1 country
1
Brief Summary
The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 24, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedDecember 18, 2012
December 1, 2012
2 years
August 24, 2012
December 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The duration of the spinal block (S1 regression of the block)
the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes
participanta will be followed on the operation day
Secondary Outcomes (1)
postoperative care unit stay
participants will be followed on the operation day
Other Outcomes (1)
maximum block level
participants will be followed on the operation day
Study Arms (2)
Group Levobupivacaine lidocaine
EXPERIMENTALGroup Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine
Group Control
ACTIVE COMPARATORGroup Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline
Interventions
Spinal anesthesia
Eligibility Criteria
You may qualify if:
- elective transurethral resection of the prostate (TUR-P)
You may not qualify if:
- patients with contraindications for spinal anesthesia,
- known sensitivity to the study drugs,
- emergency cases, and
- patients who refused spinal anaesthesia were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital
Ankara, 06110, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 18713891BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Taylan Akkaya, MD
Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 24, 2012
First Posted
August 30, 2012
Study Start
July 1, 2009
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
December 18, 2012
Record last verified: 2012-12