Using ketamine and dexamethasone to manage pain after back surgery
Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
This study is testing if giving ketamine and dexamethasone during and after back surgery can help patients manage their pain better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona) |
| Trial ID | NCT04751175 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of intravenous ketamine and dexamethasone in managing postoperative pain for patients undergoing lumbar arthrodesis. It is a Phase IV prospective randomized controlled trial conducted at a single center. The study aims to assess the analgesic effects of these medications administered perioperatively and to establish a protocol for perioperative analgesia. Participants will be monitored for pain incidence and overall pain management outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who are scheduled for lumbar arthrodesis and meet specific health criteria.
Not a fit: Patients with unstable coronary heart disease, glaucoma, or severe uncontrolled diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management for patients undergoing lumbar arthrodesis.
How similar studies have performed: Other studies have shown promising results with similar analgesic approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female * Age\> 18 years * ASA I-III. * Lumbar arthrodesis. * Patients who have signed the preoperative informed consent for participation in the study. Exclusion Criteria: * Unstable coronary heart disease * Glaucoma * History of allergy to ketamine, dexamethasone, or morphic chloride * Dementia or inability to understand IC and study * Pluricomplicated diabetes mellitus difficult to control * Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
Where this trial is running
Girona
- Hospital Dr Josep Trueta — Girona, Spain (Recruiting)
Study contacts
- Principal investigator: Emili Leon, MD — Hospital Dr Josep Trueta and Hospital Santa Caterina
- Study coordinator: Cristina Martinez, Sc
- Email: cmartinez@idibgi.org
- Phone: 972940200
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.