NCT02274974CompletedPhase 4
Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.
Ain Shams Maternity Hospital1 site in 1 country160 target enrollmentStarted: August 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Ain Shams Maternity Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Timing of first analgesic request.
Study Overview
Brief Summary
Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.
Detailed Description
assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 38 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women undergoing caesarean delivery under General anesthesia for various indications.
- •Women refuse spinal anesthesia.
Exclusion Criteria
- •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.
Arms & Interventions
lidocaine
Active Comparator
20 ml of 2% lidocaine.
Intervention: Lidocaine (Drug)
lidocaine and epinephrine.
Experimental
20 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).
Intervention: lidocaine and Epinephrine (Drug)
Outcomes
Primary Outcomes
Timing of first analgesic request.
Time Frame: 24 hours
Secondary Outcomes
- Side effects of local infiltration of lidocaine and epinephrine(7 days)
- Postoperative pyrexia(24 hours)
- Duration of hospital stay(24 hours to 48 hours)
- Duration of cesarean section(30 min to 90 min)
- Onset of mobilization(24 hours)
- Onset of breast breastfeeding(24 hours)
Investigators
AMR HELMY YEHIA
Lecturer in Obstetrics and Gynaecology
Ain Shams Maternity Hospital
Study Sites (1)
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