Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study

Conditions
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Postoperative Pain, Acute

Intervention / Treatment
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* Drug: Ketorolac
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br>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. | Other: Control<br>* After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected<br>* Other names: Saline without drugs;|
| Active Comparator: ketorolac<br>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. | Drug: Ketorolac<br>* After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 30 mg ketorolac tromethamine diluted in normal saline in a total volume of 50 ml will be injected<br>* Other names: Biorolac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative analgesic duration | the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient | within 24 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at rest | 0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain. | at 2, 4, 6, 12, 24 hours after 24 hours after surgery | 
| Postoperative pain at movement | 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. | at 2, 4, 6, 12, 24 hours after 24 hours after surgery | 
| Total postoperative analgesic consumption | total amount of fentanyl as requested by the patient | within the first 24 hours after surgery | 
| time to sensory recovery from spinal anesthesia | time to receovery of pin brick sensation at S1 | through the intraoperative or postoperative care unit | 
| time to motor recovery from spinal anesthesia | time to modified Bromage score 0 | through the intraoperative or postoperative care unit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries