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

Primary Purpose

Postoperative Pain, Acute

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ketorolac
Control
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain, Acute focused on measuring ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mansoura University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

control

ketorolac

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The postoperative analgesic duration
the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient

Secondary Outcome Measures

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.
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.
Total postoperative analgesic consumption
total amount of fentanyl as requested by the patient
time to sensory recovery from spinal anesthesia
time to receovery of pin brick sensation at S1
time to motor recovery from spinal anesthesia
time to modified Bromage score 0

Full Information

First Posted
September 14, 2022
Last Updated
March 13, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05543785
Brief Title
Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries
Acronym
K-IVRAg
Official Title
Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Acute
Keywords
ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
An anesthetist, not involved in the study, was responsible for randomization list construction, in blocks, opening the sealed envelopes and so, the preparation of the study drugs. The patient and the data collectors (anesthesia resident) does not know the group assignment.
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
ketorolac
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
ketolac, Toradol, Biorolac
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Saline without drugs
Intervention Description
After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected
Primary Outcome Measure Information:
Title
The postoperative analgesic duration
Description
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 Outcome Measure Information:
Title
Postoperative pain at rest
Description
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
Title
Postoperative pain at movement
Description
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
Title
Total postoperative analgesic consumption
Description
total amount of fentanyl as requested by the patient
Time Frame
within the first 24 hours after surgery
Title
time to sensory recovery from spinal anesthesia
Description
time to receovery of pin brick sensation at S1
Time Frame
through the intraoperative or postoperative care unit
Title
time to motor recovery from spinal anesthesia
Description
time to modified Bromage score 0
Time Frame
through the intraoperative or postoperative care unit
Other Pre-specified Outcome Measures:
Title
superficial vnous thrombophilibitis
Description
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
Title
postoperative bleeding tendency
Description
the amount of the wound drain
Time Frame
over the first 24 hours after surgery
Title
wound healing
Description
time to all wound sutures removed
Time Frame
postoperative till the time to remove all wound sutures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha AboZeid, MD
Phone
02-01019216192
Email
mahazed@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Moataz M Emara, MD, EDAIC
Phone
01064048848
Ext
+20
Email
mm.emara@mans.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha AboZeid, MD
Organizational Affiliation
Mansoura University, Faculty of Medicine -
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha A Abozeid, MD
Phone
00201019216192
Email
Mahazed@mans.edu.eg
First Name & Middle Initial & Last Name & Degree
Moataz M Emara, Md, EDAIC
Phone
+201064048848
Email
mm.emara@mans.edu.eg

12. IPD Sharing Statement

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Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

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