Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine

Study Overview
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Brief Summary
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Study to compare between efficacy of post-caesarean section infiltration with lidocaine and epinephrine versus lidocaine only to reduce post-incisional pain.

Detailed Description
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assessment of adding of epinephrine to lidocaine as local infiltrator to post-caesarean section wound in prolongation of its anaesthetic effect.

Official Title
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Post-Caesarean Section Incisional Infiltration With Lidocaine Versus Lidocaine and Epinephrine;Randomized Controlled Trial.

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Lidocaine
* Drug: lidocaine and Epinephrine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine<br>20 ml of 2% lidocaine. | Drug: Lidocaine<br>* •The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.<br>* Other names: local anaesthetic agent.;|
| Experimental: lidocaine and epinephrine.<br>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). | Drug: lidocaine and Epinephrine<br>* 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.<br>* Other names: local anaesthetic agent.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timing of first analgesic request. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of cesarean section |  | 30 min to 90 min | 
| Onset of breast breastfeeding |  | 24 hours | 
| Onset of mobilization | first time patient start moving after the section | 24 hours | 
| Duration of hospital stay |  | 24 hours to 48 hours | 
| Side effects of local infiltration of lidocaine and epinephrine |  | 7 days | 
| Postoperative pyrexia | <38°c | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cs, incisional, infiltration, lidocaine, epinephrine, Adverse Reaction to Topical or Infiltrative Lidocaine