The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

Study Overview
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Brief Summary
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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.

Detailed Description
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Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain. Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section. The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15). Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

Official Title
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The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

Conditions
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Pain Relief

Intervention / Treatment
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* Drug: Local, pre-incisional injection of 20 ml 1% xylocaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylocaine<br>Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site | Drug: Local, pre-incisional injection of 20 ml 1% xylocaine<br>* Local, pre-incisional injection of 20 ml 1% xylocaine<br>|
| Placebo Comparator: Controls<br>Participants will receive injection of 0.9% NaCl 20 ml to the incision site | Drug: Local, pre-incisional injection of 20 ml 1% xylocaine<br>* Local, pre-incisional injection of 20 ml 1% xylocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of post operative pain on a visual analog scale |  | Up to 48 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of operative scar, compared to previous scar |  | 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Xylocaine, Casarean section, Post operative pain, Scar quality