Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

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Description

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.

Targeted Conditions

Study Overview

Start Date
November 1, 2022
Completion Date
December 30, 2024
Enrollment
76
Date Posted
September 16, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Mansoura University Hospitals
Mansoura, Egypt

Eligibility

Minimum Age (years)
19
Maximum Age (years)
60
Eligibility Criteria
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 Contact Info

Study Contact Name
Maha AboZeid, MD; Moataz M Emara, MD, EDAIC
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT05543785