Adding dexmedetomidine to spinal bupivacaine for pain relief during knee surgery
The Analgesic Effect of Intrathecal Dexmedetomidine With Bupivacaine, in Patients Undergoing Knee Orthopedic Surgery: A Randomized Double-Blinded Dose-Finding Trial
This trial tests whether small intrathecal doses of dexmedetomidine added to spinal bupivacaine can prolong pain relief after knee surgery in adult men.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07522736 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares three intrathecal doses of dexmedetomidine (4, 8, and 12 μg) given with hyperbaric bupivacaine for patients undergoing knee orthopedic surgery. The primary outcome is duration of analgesia and the secondary outcome is the profile of adverse effects. Male adults aged 18–65 with ASA physical status I–II are eligible and receive a single spinal anesthetic with the assigned adjunct dose. The study is conducted at a single center (Cairo University) and monitors postoperative pain duration and safety measures without increasing the local anesthetic dose.
Who should consider this trial
Good fit: Ideal candidates are male adults aged 18–65 with ASA I–II scheduled for knee orthopedic surgery who have no contraindications to regional anesthesia.
Not a fit: Patients who are female, outside the 18–65 age range, have contraindications to regional anesthesia, a history of hypersensitivity to the drugs, psychiatric disorders, or recent opioid/CNS depressant use are unlikely to qualify or benefit.
Why it matters
Potential benefit: If successful, adding intrathecal dexmedetomidine could provide longer-lasting spinal anesthesia and reduce the need for postoperative opioids.
How similar studies have performed: Previous clinical reports have shown that dexmedetomidine as an intrathecal adjunct can enhance and prolong analgesia, though optimal dosing strategies remain under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 18 to 65 years. * American Society of Anesthesiologists (ASA) physical status I-II. * Male patients scheduled for knee orthopedic surgery. Exclusion Criteria: * Patients with psychiatric disorders. * History of drug addiction. * Contraindication for regional anesthesia. * History of hypersensitivity to the study drugs. * Previous administration of opioids and/or other central nervous system depressants during current hospital admission.
Where this trial is running
Cairo
- Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed A Ismail, MSc
- Email: ahmed.ali39348@postgrad.kasralainy.edu.eg
- Phone: 00201115746779
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.