Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy
A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy
1 other identifier
interventional
93
1 country
1
Brief Summary
The purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 6, 2012
CompletedFirst Posted
Study publicly available on registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedApril 22, 2015
December 1, 2012
3 months
March 6, 2012
April 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of spinal block
Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.
day of surgery
Secondary Outcomes (1)
Discharge time
Day of surgery
Study Arms (3)
Bupivacaine(Group B)
ACTIVE COMPARATORspinal anesthesia
Bupivacaine+Lidocaine (Group BL)
EXPERIMENTALspinal anesthesia
Local Infitration Anesthesia(Group LI)
ACTIVE COMPARATORlocal infiltration anesthesia
Interventions
To receive 2 ml heavy bupivacaine + 0,6 ml saline
To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.
Eligibility Criteria
You may qualify if:
- Patients having inguinal hernia
- Not hypersensitive to study drugs
- ASA classification I-III
You may not qualify if:
- ASA classification IV-V
- Contraindications for spinal anesthesia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diskapi Yildirim Beyazit Training and Research Hospital
Ankara, 06610, 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
- PRINCIPAL INVESTIGATOR
Dilek Yazicioglu
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor Specialist in Anesthesiology Principal investigator
Study Record Dates
First Submitted
March 6, 2012
First Posted
March 8, 2012
Study Start
March 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
April 22, 2015
Record last verified: 2012-12