CompletedNot Applicable

Epidural Nalbuphine Versus Dexmedetomidine as Adjuvants to Bupivacaine in Lower Limb Surgeries

Egypt23 participantsStarted 2021-10-01

Plain-language summary

Combined spinal epidural anesthesia (CSE) with bupivacaine alone is not sufficient to cover pain sequel during lower limb surgeries. Previous studies used addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia giving a good result in pain control. In this study the investigators will evaluate and compare the addition of either Nalbuphine or dexmedetomidine to bupivacaine in epidural anesthesia to evaluate the analgesic efficacy of either drug.

Who can participate

Age range

21 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patient acceptance. * BMI 25-29.9 kg/m2. * ASA I and ASA II. * Scheduled for elective lower limb orthopedic surgeries under (CSE) block. Exclusion Criteria: * Patient with known allergy to study drugs, * Patients suffering from severe chronic diseases (cardiac, renal, hepatic and neurological or diabetes), * Patients with infection at the site of spinal-epidural block, * Drug addict patients, * Patients on long term steroid therapy, * Patients with abnormalities in vertebral spine, * Mentally retarded or uncooperative patients, * Patients receive anti-coagulant therapy or suspected coagulopathy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Duration of epidural analgesia

Timeframe: within 24 hour postoperative

Maximum level of sensory blockade

Timeframe: after 30 min of administering the local anesthetic in the epidural space

Trial details

NCT IDNCT05041270

SponsorZagazig University

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-04-30

View on ClinicalTrials.gov More Lower Limb Surgeries trials