Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine
1 other identifier
interventional
160
1 country
1
Brief Summary
Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.
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 Aug 2014
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 21, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 25, 2015
June 1, 2015
7 months
October 21, 2014
June 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Timing of first analgesic request.
24 hours
Secondary Outcomes (6)
Duration of cesarean section
30 min to 90 min
Onset of breast breastfeeding
24 hours
Onset of mobilization
24 hours
Duration of hospital stay
24 hours to 48 hours
Side effects of local infiltration of lidocaine and epinephrine
7 days
- +1 more secondary outcomes
Study Arms (2)
lidocaine
ACTIVE COMPARATOR20 ml of 2% lidocaine.
lidocaine and epinephrine.
EXPERIMENTAL20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000. I.e.: by adding 1/4 from ampoule of adrenaline 1mg./1ml to bottle of lidocaine Hydrochloric acid (HCL) 2% 50 ml(20mg/ml).
Interventions
•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.
The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.
Eligibility Criteria
You may qualify if:
- Women undergoing caesarean delivery under General anesthesia for various indications.
- Women refuse spinal anesthesia.
You may not qualify if:
- Known or suspected sensitivity to local anesthesia.
- Medical disorders induced by pregnancy (Pre-eclamptic toxemia, gestational diabetes mellitus, Hepatic diseases, homeostatic disorder)
- Medical disorders aggravated by pregnancy (cardiovascular disease, pulmonary disease, renal disease, neurological disease, metabolic or infectious diseases).
- Women who hemo-dynamically unstable.
- Lack of adequate verbal communication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;
Cairo, 11511, Egypt
Related Publications (1)
AbdElRhman G Ali,cairo,egypt,Post-Caerarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amr H Yhia, M.D, MRCOG
Ain Shams Maternity Hospital(AinShamsMH)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer in Obstetrics and Gynaecology
Study Record Dates
First Submitted
October 21, 2014
First Posted
October 27, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
June 25, 2015
Record last verified: 2015-06