Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

Study Overview
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Brief Summary
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Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section. Group 1: bupivacaine 0.25% + dexamethasone 8 mg Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.

Detailed Description
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The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects . Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.

Official Title
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Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: bupivacaine
* Drug: dexamethasone
* Drug: placebo to dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia Exclusion Criteria: Participants had known sensitivity to bupivacaine patient refusal, localized infection over injection point patients with significant coagulopathies and with contraindications to regional anesthesia, patients with heart diseases, altered renal or liver functions, psychological disorders, patients with pregnancy-induced hypertension and gestational diabetes, chronic use of pain medications,

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 and dexamethasone<br>Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline. | Drug: bupivacaine<br>* TAP block with 20 ml of 0.25% bupivacaine bilaterally<br>* Other names: Active Comparator;Drug: dexamethasone<br>* TAP block with 4 mg dexamethasone bilaterally<br>* Other names: active comparator;|
| Active Comparator: bupivacaine and placebo to dexamethasone<br>BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone | Drug: bupivacaine<br>* TAP block with 20 ml of 0.25% bupivacaine bilaterally<br>* Other names: Active Comparator;Drug: placebo to dexamethasone<br>* TAP block with 4 mg placebo to dexamethasone bilaterally<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score for pain during movement | movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain | 6 hours post operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog score during rest | ranging from 0 to 10, where 0 no pain and 10 maximum pain | 48 hours postoperative | 
| number of patients need Fentanyl consumption | number of patients need Fentanyl consumption | 48 hours postoperative | 
| number of days patients stay in hospital | calculation of number of days patients stay in hospital | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexamethasone, transversus abdominis plane block, cesarean section