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The postoperative pain management after cesarean section under spinal anestheisa is done using various modalities. The commonly used regimens are systemic NSAIDs/Opioids, USG guided TAP block or Intrathecal additive Fentanyl or combined intrathecal fentanyl and USG guided TAP block.
Investigators aim to compare the postoperative analgesia in terms of time to the first rescue analgesic in parturients receiving intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone for elective CS done under hyperbaric bupivacaine spinal anesthesia.
Investigators will enroll 93 parturients planned for elective CS under hyperbaric bupivacaine spinal anesthesia and allocate them into three groups comprising intrathecal additive fentanyl only, or intrathecal fentanyl with USG guided TAP block or USG guided TAP block alone.
The primary outcome will be time to the first rescue analgesics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group F | Experimental | The intrathecal additive Fentanyl with hyperbaric bupivacaine |
|
| Group FT | Experimental | The intrathecal additive of fentanyl with hyperbaric bupivacaine along with Ultrasound-guided TAP block |
|
| Group T | Experimental | Hyperbaric bupivacaine along with Ultrasound-guided TAP block without the intrathecal addition of fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl HCl | Drug | Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the time to the first rescue analgesics | The time from the arrival to Postoperative care Unit to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia | Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with treatment related side effects like pruritus, nausea and vomiting. | To compare the side effects like pruritus, nausea and vomiting Among Parturients among the Parturients Receiving Intrathecal Additive Fentanyl or Intrathecal Fentanyl With TAP Block or TAP Block Alone for Elective Cesarean Sections Under Hyperbaric Bupivacaine Spinal Anesthesia | Time to first complain of pain with Numeric Rating scale(NRS) greater than or equal to 4 within first 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bijay Rayamajhi, FCPS | Nepal Mediciti Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nepal Mediciti Hospital | Lalitpur | Nepal |
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| Bupivacaine 0.25% Injectable Solution | Drug | Intrathecal additive Fentanyl with Hyperbaric Bupivacaine during Spinal Anesthesia Ultrasound-guided Transversus Abdominal plane block using Bupivacaine 0.25% Injectable Solution |
|
|
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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