Postoperative Pain, AcuteK-IVRAgNCT05543785
Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries
A study testing Ketorolac in people with Postoperative Pain, Acute, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical status I or II
- Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospitals
Al Mansurah
Maha A Abozeid, MD, 00201019216192, Mahazed@mans.edu.eg
Moataz M Emara, Md, EDAIC, +201064048848, mm.emara@mans.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Ketorolac, Control
- Keywords
- ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Also called ketolac, Toradol, Biorolac
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
ControlOther
Also called Saline without drugs
After confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected
| Study group | Role | What they receive |
|---|---|---|
| control | Placebo comparator | 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. Receives: Other: Control |
| ketorolac | Active comparator | 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. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative analgesic duration
the time measured from the onset of spinal anesthesia to the first request of analgesia by the patient
Measured: within 24 hours after the surgery
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: within the first 24 hours after surgery
time to sensory recovery from spinal anesthesia
time to receovery of pin brick sensation at S1
Measured: through the intraoperative or postoperative care unit
time to motor recovery from spinal anesthesia
time to modified Bromage score 0
Measured: through the intraoperative or postoperative care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start1 Nov 2022
- Primary completion30 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
- Investigators
- Maha AboZeid, MD, Study director, Mansoura University, Faculty of Medicine -
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543785
- Sponsor's protocol ID
- R.22.09.1832
- Acronym
- K-IVRAg
- Status last verified
- Feb 2026
- First submitted
- 14 Sep 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac for Intravenous Regional Analgesia in Lower Limb Orthopedic Surgeries Under Spinal Anesthesia: A Randomized Control Study
- ClinicalTrials.gov ID
- NCT05543785
- Acronym / sponsor ID
- K-IVRAg / R.22.09.1832
- Conditions
- Postoperative Pain, Acute
- Keywords
- ketorolac, randomized controlled trial, intravenous regional anesthesia, lower limb, orthopedic surgeries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Placebo comparator | Other: Controlwill 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. |
| ketorolac | Active comparator | Drug: Ketorolacwill 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. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical status I or II
- Elective unilateral lower limb orthopedic surgery with tourniquet under spinal anesthesia
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetorolacAlso: ketolac, Toradol, BiorolacAfter 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 | Drug | ketorolac |
| ControlAlso: Saline without drugsAfter confirmation of circulatory isolation of the operated limb by the inflated tourniquet, 50 ml normal saline without drugs will be injected | Other | control |
Primary outcome
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
5 secondary outcomes
Postoperative pain at rest
Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery
Postoperative pain at movement
Time frame: at 2, 4, 6, 12, 24 hours after 24 hours after surgery
Total postoperative analgesic consumption
Time frame: within the first 24 hours after surgery
time to sensory recovery from spinal anesthesia
Time frame: through the intraoperative or postoperative care unit
time to motor recovery from spinal anesthesia
Time frame: through the intraoperative or postoperative care unit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maha AboZeid, MD study director
Mansoura University, Faculty of Medicine -
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac in people with Postoperative Pain, Acute, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha AboZeid, MD (02-01019216192, mahazed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The postoperative analgesic duration (time frame: within 24 hours after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.