Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

ConditionPostoperative Pain, Acute

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age19-60

SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists physical status I or II

Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia

Disqualifiers

Pregnant females

Body mass index ≥ 35 kg/m2

Allergy to ketorolac

Had renal, asthmatic, vascular (Raynaud's syndrome) disease, hematological anemias

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: controlPlacebo comparator 1 intervention

Group B: ketorolacActive comparator 1 intervention

Trial 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

Other outcomes

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

Time frame

intraoperative period

postoperative bleeding tendency

the amount of the wound drain

Time frame

over the first 24 hours after surgery

wound healing

time to all wound sutures removed

Time frame

postoperative till the time to remove all wound sutures

Sponsors and contacts

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Mansoura University

Lead sponsor

Source ClinicalTrials.gov

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