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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bupivacaine and dexamethasone | Active Comparator | Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline. |
|
| bupivacaine and placebo to dexamethasone | Active Comparator | BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bupivacaine | Drug | TAP block with 20 ml of 0.25% bupivacaine bilaterally |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
healthy parturient scheduled to undergo LSCS under spinal anesthesia
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| Name | Affiliation | Role |
|---|---|---|
| hany f sallam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University | Aswān | 81528 | Egypt |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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A prospective Randomized Interventional double-blind study.
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Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
| dexamethasone | Drug | TAP block with 4 mg dexamethasone bilaterally |
|
|
| placebo to dexamethasone | Drug | TAP block with 4 mg placebo to dexamethasone bilaterally |
|
|
| 48 hours postoperative |
| number of days patients stay in hospital | calculation of number of days patients stay in hospital | 4 weeks |
| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |