Pain Relief Clinical Trial
Official title:
The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section
This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - Candidates for non-emergency cesarean section Exclusion Criteria: - Emergency cesarean section - Known or suspected sensitivity to local anesthetics - Pre-eclamptic toxemia - Deranged liver function - Deranged hemostasis - Lack of adequate verbal communication |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Department of Obstetrics & Gynecology, Baruch Padeh Medical Center | Poriya |
Lead Sponsor | Collaborator |
---|---|
The Baruch Padeh Medical Center, Poriya |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Level of post operative pain on a visual analog scale | Up to 48 hours postoperative | No | |
Secondary | Appearance of operative scar, compared to previous scar | 6-8 weeks | No |
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