Actively Recruiting
Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Controlled Study
Led by Mansoura University · Updated on 2026-02-17
76
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intravenous ketorolac as a regional analgesic during lower limb orthopedic surgeries performed with a tourniquet and spinal anesthesia. The study aims to compare the effects of ketorolac injected directly into the isolated limb versus ketorolac given intravenously before tourniquet inflation, focusing on how long the postoperative pain relief lasts. Participants will be randomly assigned to one of two groups: one receiving ketorolac injected into the isolated limb after tourniquet inflation and a saline injection into the general circulation, and the other receiving saline in the isolated limb with ketorolac given intravenously before tourniquet pressure. All patients will also receive standard spinal anesthesia and postoperative pain medications such as paracetamol and diclofenac. During the study, participants will be monitored for pain levels at rest and during movement at several time points within 24 hours after surgery. Researchers will also record the total amount of pain medication used, as well as how quickly sensory and motor function recover from spinal anesthesia. The primary outcome is the duration of pain relief after surgery, with safety and recovery closely observed throughout the postoperative period.
CONDITIONS
Brief Title
Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- American Society of Anesthesiologists physical status I or II
- Scheduled for elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia
- Age between 19 and 60 years
You will not qualify if you...
- Pregnant females
- Body mass index of 35 kg/m2 or higher
- Allergy to ketorolac
- History of renal disease, asthma, vascular disease such as Raynaud's syndrome, or hematological anemias
- History of gastrointestinal tract inflammation, bleeding, ulceration, or perforation
- Edema in the operated limb grade 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive spinal anesthesia and are randomized to receive either ketorolac or placebo via intravenous regional analgesia during lower limb surgery with a tourniquet.
1 surgery visit (in-person)
Duration - 24 hours after surgery
Participants are monitored for postoperative pain, sensory and motor recovery, and analgesic consumption for 24 hours after surgery.
Assessments at 2, 4, 6, 12, and 24 hours post-surgery
Trial Site Locations
Total: 1 location
1
Mansoura University Hospitals
Al Mansurah, Egypt
Actively Recruiting
Research Team
M
Maha AboZeid, MD
M
Moataz M Emara, MD, EDAIC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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