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NCT Number: NCT05543785

Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

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.

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Key information

Conditions

Postoperative Pain, Acute Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: ketolac, Toradol, Biorolac

Control

Other

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

Other names: Saline without drugs

Primary outcomes

  1. The postoperative analgesic duration

    Time frame: within 24 hours after the surgery

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

Secondary outcomes

  1. Postoperative pain at rest

    Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery

    0-10 centimetres visual analog scale (VAS) for pain, where zero is equal to no pain and ten indicates the worst possible pain.

  2. Postoperative pain at movement

    Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery

    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.

  3. Total postoperative analgesic consumption

    Time frame: within the first 24 hours after surgery

    total amount of fentanyl as requested by the patient

  4. time to sensory recovery from spinal anesthesia

    Time frame: through the intraoperative or postoperative care unit

    time to receovery of pin brick sensation at S1

  5. time to motor recovery from spinal anesthesia

    Time frame: through the intraoperative or postoperative care unit

    time to modified Bromage score 0

Other outcomes

  1. superficial vnous thrombophilibitis

    Time frame: intraoperative period

    redness or warmth noted at the proximal course of the injected vein before sterilization for surgery and at the end of surgery

  2. postoperative bleeding tendency

    Time frame: over the first 24 hours after surgery

    the amount of the wound drain

  3. wound healing

    Time frame: postoperative till the time to remove all wound sutures

    time to all wound sutures removed

Study contacts

Contact information is provided by the study sponsor or research team.

Maha AboZeid, MD

CONTACT

[email protected]

02-01019216192

Moataz M Emara, MD, EDAIC

CONTACT

[email protected]

01064048848 ext. +20

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: K-IVRAg

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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