Transverse Abdominal Block for Analgesia in Casarean Section

Study Overview
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Brief Summary
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In this study, the investigators will compare the analgesic effect of bupivacaine and bupivacaine-dexmetomedine after elective cesarean delivery by performing an bilateral TAP block, on the patients for whom the operation will be performed under general anesthesia.

Detailed Description
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The investigators will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery at tanta University Hospital, in a prospective, randomized, comparative, clinical trial. Patients will be randomly allocated to two equal groups (n = 30) using closed envelopes labeled 1,and 2 reflecting group 1and 2 respectively. The drugs are prepared by the anesthesiologist who is not involved in the study or data collection. Group I: (n=30) will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2. Group II: (n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G2.

Official Title
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The Value of Preemptive Dexmedetomidine Transversus Abdominis Plane (TAP) Block in Patients Undergoing Elective Cesarean Section Under General Anesthesia.

Conditions
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Analgesia Disorder

Intervention / Treatment
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* Drug: Bupivacine group
* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: We will study 60 ASA [American Society of Anesthesiologist] physical status I and ІІ patients undergoing elective cesarean delivery Age between 21-40 years old. Exclusion Criteria: Refusal of participation in the study Patients who have infection or tumor at the site of puncture for local anesthetic injection. Patients who have coagulopathy, platelet abnormalities, and concurrent treatment with anticoagulant drugs. Patients known to have allergy or sensitivity to dexmetomedine, and/or bupivacaine Severe hepatic and/or renal insufficiency Morbid obesity (body mass index (BMI) >35) Psychological disease

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dexmetomedine group<br>dexmetomedine group will receive pre-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe labeled G 2. | Drug: Dexmedetomidine<br>* Dexamedtomedine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe<br>* Other names: precdex;|
| Active Comparator: Bupivacaine group<br>Bupivacaine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline in 20 ml syringe labeled G 2. | Drug: Bupivacine group<br>* Bupivacaine group(n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe<br>* Other names: Bucaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic changes | blood pressure and heart rate measured every 15 minutes during the intraopertive peroid | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic requirements | VAS will be measured during 24 hours after surgery every 4 hours | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, casarean section, TAP block