Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries (K-IVRAg)

Mansoura University

Status: Enrolling

Conditions: Postoperative Pain, Acute

Treatments: Other: Control; Drug: Ketorolac

Study type: Interventional

Funder types: Other

Identifiers

NCT05543785

R.22.09.1832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

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.

Treatment:

Other: Control

ketorolac

Active Comparator group

Description:

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.

Treatment:

Drug: Ketorolac