Dexmedetomidine Versus Clonidine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section

Study Overview
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Brief Summary
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Aim to study the efficacy of co-administered Dexmedetomidine Or Clonidine with Bupivacaine and that of bupivacaine 0.25% alone for Transversus Abdominis Plane (TAP) Block for Postoperative Analgesia in Patients Undergoing Elective Caesarean Section. Group 1: bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.) Group 2: 20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP Group3: bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP A prospective Randomized Interventional double-blind study.

Detailed Description
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Women, following Caesarean delivery, have even more compelling reasons to receive optimal post-operative pain relief, for improved maternal and neonatal well-being. Also, adequate pain relief helps the patient to ambulate early and prevent any thrombotic incidents . Dexmedetomidine, an imidazole compound, is the pharmacologically active dextroisomer of medetomidine that displays specific and selective α 2-adrenoceptor agonist activity and causes sedation, analgesia without any delirium, or respiratory depression. The mechanism of action is unique and differs from those of currently used agents, including clonidine.

Official Title
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Role of Co-administered Dexmedetomidine Or Clonidine With Bupivacaine for Transversus Abdominis Plane Block in Patients Undergoing Elective Caesarean Section: A Randomized, Double-blind Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: bupivacaine
* Drug: Dexmedetomidine
* Drug: clonidine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: parturients scheduled to undergo cesarean section under spinal anesthesia Exclusion Criteria: Patients who refused spinal anesthesia women with chronic pelvic pain or on chronic morphine use history of drug allergy coagulation disorder

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective Randomized Interventional double-blind study.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine 0.25% and Dexmedetomidine<br>bupivacaine 0.25% + Dexmedetomidine 0.5 mcg/kg (a total volume of 40 ml (20 ml each side) was used for the TAP block.) | Drug: bupivacaine<br>* bupivacaine 0.25% a total volume of 40 ml (20 ml each side<br>* Other names: Active Comparator;Drug: Dexmedetomidine<br>* Dexmedetomidine 0.5 mcg/kg<br>* Other names: Active Comparator;|
| Active Comparator: bupivacaine and clonidine<br>20 ml bupivacaine+1ug/kg clonidine bilaterally (a total volume of 40 ml (20 ml each side) was used for the TAP | Drug: bupivacaine<br>* bupivacaine 0.25% a total volume of 40 ml (20 ml each side<br>* Other names: Active Comparator;Drug: clonidine<br>* 1ug/kg clonidine<br>* Other names: Active Comparator;|
| Placebo Comparator: bupivacaine and placebo<br>bupivacaine 0.25% + placebo (a total volume of 40 ml (20 ml each side) was used for the TAP | Drug: bupivacaine<br>* bupivacaine 0.25% a total volume of 40 ml (20 ml each side<br>* Other names: Active Comparator;Drug: placebo<br>* add placebo 9normal saline)<br>* Other names: placebo comparator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for first rescue analgesia after the TAP block | calculation the time needed for first rescue analgesia after the TAP block | 24 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total dose of rescue analgesia | calculation of Total dose of rescue analgesia required in 24 h post-operatively | 24 hours postoperative | 
| Adverse effects | Adverse effects like pruritus, nausea and vomiting, hypotension, bradycardia, and sedation. | 24 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Dexmedetomidine, Clonidine, Transversus Abdominis Plane Block