Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-25 @ 4:03 PM
Study NCT ID:
NCT07244757
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control
Sponsor:
Cairo University
Organization:
Study Overview
Official Title:
Comparison of Two Dosing Regimens of Intravenous Ketorolac for Post-Cesarean Pain Control: A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ketorolac, an intravenous NSAID widely used in perioperative pain management, has been shown to reduce pain scores and opioid requirements following cesarean delivery. However, its optimal dosing regimen remains uncertain, with previous studies using doses ranging from 15 mg to 60 mg. A retrospective analysis found no significant difference between 15 mg and 30 mg doses when combined with neuraxial opioids, possibly due to overlapping multimodal analgesia components. To date, no study has directly compared 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.
Detailed Description:
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol orally then every 6 h postoperatively (initially intravenously, then orally once oral intake is permitted) Upon arrival to the operating room, routine monitors (ECG, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and pre-medication drugs will be delivered (metoclopramide 10 mg). Lactated Ringer's co-load will be rapidly infused at a rate of 15 mL.Kg-1 over 10 minutes \[10\]. Spinal anesthesia will be achieved by injecting 10 mg hyperbaric bupivacaine 0.5% plus 25 mcg fentanyl in L3-L4 or L4-L5 interspace. Prophylactic vasopressor will be administered in all patients, either ephedrine bolus (9 mg) or norepinephrine infusion (0.08 mcg/kg/min) according to the preference of the attending physician.
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 by the obstetrician in charge using a sterile needle along the line of the wound in 3 to 4 separate portions, 15 mL of 0.25% bupivacaine on each side (30 mL total volume).
Postoperatively, pain assessments using the NRS will be performed at rest and during movement (change position from supine to sitting or ambulation) at 0.5, 6, 12, 18, and 24 h after leaving the operating room. If the NRS score 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.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting.
At the end of the 24-h postoperatively, the quality of recovery will be assessed using the ObsQoR-11 score.
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 by the obstetrician in charge using a sterile needle along the line of the wound in 3 to 4 separate portions, 15 mL of 0.25% bupivacaine on each side (30 mL total volume).
Postoperatively, pain assessments using the NRS will be performed at rest and during movement (change position from supine to sitting or ambulation) at 0.5, 6, 12, 18, and 24 h after leaving the operating room. If the NRS score 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.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting.
At the end of the 24-h postoperatively, the quality of recovery will be assessed using the ObsQoR-11 score.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: