Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

Mansoura University76 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Postoperative Pain, Acute

KetorolacDRUG

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

ControlOTHER

After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected

Eligibility

Sex: ALLMin age: 19 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The postoperative analgesic duration

the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient

Time frame: within 24 hours after the surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: within the first 24 hours after surgery

time to sensory recovery from spinal anesthesia

time to receovery of pin brick sensation at S1

Time frame: through the intraoperative or postoperative care unit

time to motor recovery from spinal anesthesia

time to modified Bromage score 0