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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Placebo Comparator | 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. |
|
| ketorolac | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac | Drug | 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| superficial vnous thrombophilibitis | redness or warmth noted at the proximal course of the injected vein before sterilization for surgery and at the end of surgery | intraoperative period |
| postoperative bleeding tendency |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha AboZeid, MD | Contact | 02-01019216192 | mahazed@mans.edu.eg | |
| Moataz M Emara, MD, EDAIC | Contact | 01064048848 | +20 | mm.emara@mans.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Maha AboZeid, MD | Mansoura University, Faculty of Medicine - | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals | Recruiting | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D020911 | Ketorolac Tromethamine |
| D012965 | Sodium Chloride |
| D004364 | Pharmaceutical Preparations |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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An anesthetist, not involved in the study, was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drugs. The patient and the data collectors (anesthesia resident) does not know the group assignment.
|
| Control | Other | After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected |
|
|
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 |
the amount of the wound drain
| over the first 24 hours after surgery |
| wound healing | time to all wound sutures removed | postoperative till the time to remove all wound sutures |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |