Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries
- Conditions
- Postoperative Pain, Acute
- Interventions
- Other: Control
- Registration Number
- NCT05543785
- Lead Sponsor
- Mansoura University
- Brief Summary
Tourniquet, a compressing device, otherwise its use in intravenous regional anesthesia, is commonly used in particular orthopedic surgeries. From the previous documented effectiveness and safety of intravenous (IV) administration of ketorolac in the circulatory-isolated limb as a part of intravenous regional anesthesia; we hypothesized that in orthopedic surgeries done with tourniquet, intravenous (IV) administration of ketorolac after tourniquet inflation, will act as intravenous regional analgesia. So, it will prolong the postoperative analgesic duration as a primary outcome.
- Detailed Description
This is a randomized controlled trial that tests the effecacy of the intravenous regional ketorolac in lower limb orthopedic surgeries with spinal anesthesia. The investigators will compare the effect of 30 mg ketorolac without local anesthetic in the injected intravenously in an isolated lower limb (with torniquet) versus intravenous 30 mg ketorolac administered 10 minutes before toniquet pressuerization on the postoperative analgesia.
All patients will receive spinal anesthesia aiming for at least T12-L1 level. Postoperative standard analgesia will be paracetamol and diclofenac, given for both groups.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- American Society of Anesthesiologists physical status I or II
- Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ketorolac Ketorolac will receive 15 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml in the intravenous regional cannula in the surgical limb with torniquet. And receive intravenous 10 ml saline in the peripheral general circulation. control Control will receive 50 ml normal saline in the intravenous regional cannula in the surgical limb with torniquet. And receive intravenous 30 mg ketorolac diluted in 10 ml saline in the peripheral general circulation.
- Primary Outcome Measures
Name Time Method The postoperative analgesic duration within 24 hours after the surgery the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient
- Secondary Outcome Measures
Name Time Method time to sensory recovery from spinal anesthesia through the intraoperative or postoperative care unit time to receovery of pin brick sensation at S1
time to motor recovery from spinal anesthesia through the intraoperative or postoperative care unit time to modified Bromage score 0
Postoperative pain at rest at 2, 4, 6, 12, 24 hours after 24 hours after surgery 0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain.
Postoperative pain at movement at 2, 4, 6, 12, 24 hours after 24 hours after surgery 0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain. Movement will be standardized as 10 cm elevation of the surgical limb off the bed.
Total postoperative analgesic consumption within the first 24 hours after surgery total amount of fentanyl as requested by the patient
Trial Locations
- Locations (1)
Mansoura University Hospitals
🇪🇬Mansoura, Egypt