Using ketorolac for pain relief in lower limb surgeries
Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study
This study tests if giving ketorolac at different times can help people having lower limb surgeries feel less pain after their operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah) |
| Trial ID | NCT05543785 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of intravenous ketorolac as a regional analgesic in patients undergoing elective unilateral lower limb orthopedic surgeries with spinal anesthesia. Participants will be randomly assigned to receive either 30 mg of ketorolac administered intravenously after tourniquet inflation or 30 mg administered 10 minutes prior to tourniquet application. The primary outcome is to assess the duration of postoperative analgesia provided by this method compared to standard analgesic protocols. All patients will also receive standard postoperative analgesia with paracetamol and diclofenac.
Who should consider this trial
Good fit: Ideal candidates are patients classified as American Society of Anesthesiologists physical status I or II, scheduled for elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia.
Not a fit: Patients who are pregnant, have a high body mass index, or have specific medical conditions such as allergies to ketorolac or renal diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance postoperative pain management for patients undergoing lower limb surgeries.
How similar studies have performed: Previous studies have shown the effectiveness of intravenous ketorolac in similar settings, suggesting a promising approach for pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists physical status I or II * Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia Exclusion Criteria: * Pregnant females * Body mass index ≥ 35 kg/m2 * Allergy to ketorolac * Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias * Had any history of gastrointestinal tract inflammation, bleeding, ulceration, or perforation besides * Edema in the operated limb grade ≥ 3
Where this trial is running
Al Mansurah
- Mansoura University Hospitals — Al Mansurah, Egypt (Recruiting)
Study contacts
- Study coordinator: Maha AboZeid, MD
- Email: mahazed@mans.edu.eg
- Phone: 02-01019216192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.