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we aim to compare the analgesic efficacy of two intravenous ketorolac dosing regimens as part of a multimodal analgesic protocol that includes local wound infiltration for postoperative pain management after elective cesarean delivery.
Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl Prophylactic vasopressor will be administered in all patients, Following delivery, all patients will receive a single dose of dexamethasone (8 mg) along with the first dose of intravenous ketorolac. Subsequent ketorolac doses will be administered every 8 hours.
After closing the fascia, the subcutaneous layer will be infiltrated with 30 mL of 0.25% bupivacaine.
Postoperatively, if the Numeric rating scale is > 3, intravenous nalbuphine 0.1 mg/kg titrated to response, with maximum single dose of 20 mg and maximum daily dose of 160 mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketorolac 30 | Active Comparator | patients will receive intravenous ketorolac at 30 mg/8 h postoperatively |
|
| ketorolac 15 mg | Active Comparator | patients will receive intravenous ketorolac at 15 mg/8 h postoperatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac 30 mg | Drug | administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| numeric rating scale at rest | the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" | 6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| numeric rating scale at rest | person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" | at 30 minutes, 12-, 18-, and 24 hours postoperatively |
| numeric rating scale during movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ahmed hasanin | Cairo University Kasr Alainy Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy Hospital | Cairo | 11562 | Egypt |
data used for analysis will be available from the PI upon reasonable requist
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketorolac 15mg | Drug | administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds. |
|
person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" during change position from supine to sitting or ambulation
| at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively |
| total nalbuphine consumption | mg | from 0.5 hour postoperatively to 24 hour postoperatively |
| time to first analgesic requirement | hours | time from immediately postoperatively to time of first analgesic requirement during the first 24 hours |
| ObsQoR-11 score | The ObsQoR-11 is an 11-item questionnaire to assess a patient's recovery after a C-section, with a total score ranging from 0 to 100, where 100 is the best possible recovery | 24 hour postoperatively |
| patient's satisfaction | At the end of the study the patient will be asked to rate her satisfaction with pain control using the NRS 10= strongly unsatisfied, 0= strongly satisfied | 24 hour postoperatively |
| D006571 | Heterocyclic Compounds |