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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Other: Control; Drug: Ketorolac

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Moataz M Emara, MD, EDAIC; Phone Number: +20 01064048848; Email: mm.emara@mans.edu.eg
• Study Contact Backup: Name: Maha Abozeid, MD; Phone Number: 02-01019216192; Email: mahazed@mans.edu.eg

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Mansoura University Hospitals
    • Contact: Moataz M Emara, MD, EDAIC; Phone Number: +201064048848; Email: mm.emara@mans.edu.eg
    • Contact: Maha A Abozeid, MD; Phone Number: 00201019216192; Email: Mahazed@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control; 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.	Other: Control; 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
Active Comparator: ketorolac; 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.	Drug: Ketorolac; 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: Toradol; ketolac; Biorolac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Maha AboZeid, MD, Mansoura University, Faculty of Medicine -

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: September 14, 2022
• First Submitted That Met QC Criteria: September 15, 2022
• First Posted (Actual): September 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: randomized controlled trial; lower limb; ketorolac; orthopedic surgeries; intravenous regional anesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketorolac
• Other Study ID Numbers: R.22.09.1832

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No