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Recruiting NCT05543785

NCT05543785 Ketorolac Intravenous Regional Analgesia in Lower Limb Surgeries

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Clinical Trial Summary
NCT ID NCT05543785
Status Recruiting
Phase
Sponsor Mansoura University
Condition Postoperative Pain, Acute
Study Type INTERVENTIONAL
Enrollment 76 participants
Start Date 2022-11-01
Primary Completion 2027-05-30

Eligibility & Interventions

Sex All sexes
Min Age 19 Years
Max Age 60 Years
Study Type INTERVENTIONAL
Interventions
KetorolacControl

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 76 participants in total. It began in 2022-11-01 with a primary completion date of 2027-05-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Maha AboZeid, MD

✉ mahazed@mans.edu.eg

📞 02-01019216192

Principal Investigator

Maha AboZeid, MD

STUDY DIRECTOR

Mansoura University, Faculty of Medicine -

Frequently Asked Questions

Who can join the NCT05543785 clinical trial?

This trial is open to participants of all sexes, aged 19 Years or older, up to 60 Years, studying Postoperative Pain, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT05543785 currently recruiting?

Yes, NCT05543785 is actively recruiting participants. Contact the research team at mahazed@mans.edu.eg for enrollment information.

Where is the NCT05543785 trial being conducted?

This trial is being conducted at Al Mansurah, Egypt.

Who is sponsoring the NCT05543785 clinical trial?

NCT05543785 is sponsored by Mansoura University. The principal investigator is Maha AboZeid, MD at Mansoura University, Faculty of Medicine -. The trial plans to enroll 76 participants.

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