Cesarean Delivery, Ketorolac, Postoperative Analgesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGKetorolac 30 mg
administered intravenously as 30 mg diluted in 10 mL of normal saline and injected over more than 15 seconds
DRUGKetorolac 15mg
administered intravenously as either 15 mg diluted in 10 mL of normal saline and injected over more than 15 seconds.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* full-term, singleton, pregnant women, * aged 18-35 years, * scheduled for elective cesarean delivery under spinal anesthesia
Exclusion criteria
* American Society of Anesthesiologists (ASA) physical class III or more * multiple gestation. Patients with a history of allergy to any of the study drugs, * renal impairment, * gastrointestinal bleeding or ulceration * inflammatory bowel disease, * chronic pain or regular opioid use. * Inability to comprehend the numeric pain scale (NRS) or the ObsQoR-11 score * requirement for conversion to general anesthesia after spinal anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numeric rating scale at rest | 6 hours postoperatively | the patient rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| numeric rating scale at rest | at 30 minutes, 12-, 18-, and 24 hours postoperatively | person rates their pain on a scale of 0 to 10, with 0 being "no pain" and 10 being the "worst pain imaginable" |
| numeric rating scale during movement | at 30 minutes, 6-, 12-, 18-, and 24 hours postoperatively | 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 |
| total nalbuphine consumption | from 0.5 hour postoperatively to 24 hour postoperatively | mg |
| time to first analgesic requirement | time from immediately postoperatively to time of first analgesic requirement during the first 24 hours | hours |
| ObsQoR-11 score | 24 hour postoperatively | 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 |
| patient's satisfaction | 24 hour postoperatively | 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 |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORahmed hasanin
Cairo University Kasr Alainy Faculty of Medicine
Outcome results
None listed