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Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group-Control | No Intervention | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side | |
| Group-Dexmedetomidine 0.5 | Active Comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side |
|
| Group-Dexmedetomidine1 | Active Comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine 0.5 mcg | Drug | 0.5 mcg/kg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The time of the first postoperative analgesic requirement | during the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the | mg | during the first 24 postoperative hours |
| The visual analog scale (VAS) scores during rest |
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Inclusion Criteria:
Exclusion Criteria:
singleton pregnant women with a gestational age of at least 37 weeks
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University-Emergency hospital-ICU | Al Mansurah | 35511 | Egypt |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
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The injectate used for TAPB will be prepared according to the group by an anesthesiologist who won't be involved in the data collection
| Dexmedetomidine 1 mcg |
| Drug |
1 mcg/kg |
|
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
| during the first 24 postoperative hours |
| The visual analog scale (VAS) scores during movement | 11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively | during the first 24 postoperative hours |
| Mean arterial blood pressure (MBP) | mmHg | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours |
| heart rate (HR) | beat per minute | basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours |
| Patient satisfaction about the quality of postoperative analgesia | poor = 1, fair = 2, good = 3, excellent = 4 | during the first 24 postoperative hours |
| The side effects (nausea, vomiting, abdominal colic and lower limb weakness) | incidence | during the first 24 postoperative hours |
| the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome | during the first 24 postoperative hours |
| The level of sedation | using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation) | during the first 24 postoperative hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |