Perioperative IV nimodipine for people undergoing open colectomy for bowel cancer
Perioperative Nimodipine for Intra- and Postoperative Pain Management and Reduction of Anesthetic Requirements in Patients Undergoing Open Colectomy: a Prospective, Double-blind, Randomized Controlled Trial
This trial tests whether giving intravenous nimodipine around the time of open colectomy can reduce opioid use, lower pain, and speed early bowel recovery for people having surgery for bowel cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Ioannina Academic / other |
| Locations | 1 site (Pátrai, Achaea) |
| Trial ID | NCT07048522 on ClinicalTrials.gov |
What this trial studies
This is a prospective double-blind, randomized controlled trial at a single center comparing perioperative IV nimodipine to isotonic saline in patients having open radical colectomy for bowel cancer. Patients receive the study drug around the time of surgery and are followed for opioid and anesthetic requirements, pain intensity, opioid-related side effects, and early postoperative bowel mobility. Key eligibility includes adults 18–75 years with ASA status I–III who are not on daily opioids and have no severe renal insufficiency or significant bradyarrhythmia. The trial aims to determine whether nimodipine can enhance analgesia and reduce opioid exposure in the immediate postoperative period.
Who should consider this trial
Good fit: Adults aged 18–75 scheduled for open radical colectomy for bowel cancer with ASA physical status I–III, able to give informed consent, not on daily opioids, and without severe renal insufficiency or bradyarrhythmia.
Not a fit: Patients older than 75, with severe renal failure, significant bradyarrhythmias, or who use daily opioids before surgery are either ineligible or unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, nimodipine could reduce perioperative opioid needs, decrease opioid side effects (like nausea and constipation), improve pain control, and speed early return of bowel function after open colectomy.
How similar studies have performed: Evidence on L-type calcium channel blockers like nimodipine for acute postoperative pain is limited and inconclusive, so this approach is relatively novel in this setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra Exclusion Criteria: * Age \< 18 years, \> 75 years * American Society of Anesthesiologists (ASA) physical status \> III * Allergy to nimodipine * Inability to provide informed consent * Known severe renal insufficiency * Known severe bradyarrhythmia * Daily opioid consumption the last 7 days before surgery * Pain intensity assessed using the Numerical Rating Scale (NRS; 0-10), with scores greater than 5 reported on more than half of the days during the past month.
Where this trial is running
Pátrai, Achaea
- St. Andrews General Hospital of Patras, GREECE — Pátrai, Achaea, Greece (Recruiting)
Study contacts
- Principal investigator: Petros Tzimas, MD, PhD — University of Ioannina, Greece
- Study coordinator: Maria-Theodora Filou, MD
- Email: marilizafilou@gmail.com
- Phone: 00306948127570
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.