Actively Recruiting
Perioperative Nimodipine for Pain Management and Reduction of Anesthetic Use in Open Colectomy: A Double-blind Randomized Controlled Trial
Led by University of Ioannina · Updated on 2025-07-02
40
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effect of perioperative intravenous nimodipine, a drug that blocks L-type calcium channels and can cross the blood-brain barrier, on pain management and anesthetic requirements in patients undergoing open colectomy for bowel cancer. The trial aims to understand how nimodipine influences opioid use, pain intensity, opioid-related side effects, and early bowel function after surgery. This prospective, double-blind, randomized controlled trial addresses the need for better pain control strategies during and after surgery while minimizing opioid-related complications. Participants are randomly assigned to receive either nimodipine or isotonic saline during the perioperative period. Nimodipine is given continuously at 4 mg/h starting one hour before surgery until one hour after surgery begins, then reduced to 2 mg/h until 24 hours after surgery ends. The control group receives a matching saline infusion at equivalent rates and timing. Both treatments are prepared in blinded syringes to maintain trial integrity. Throughout the study, patients' opioid and anesthetic consumption during surgery and up to 72 hours postoperatively are recorded. Pain intensity, side effects such as sedation, itching, nausea, vomiting, and bowel function recovery are monitored closely. Hospital stay length is also tracked. The study lasts from pre-surgery through 30 days post-surgery, with a focus on detailed pain and medication assessments in the first three days following surgery.
CONDITIONS
Brief Title
Perioperative Intravenous Nimodipine Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients scheduled for open surgical treatment of bowel cancer at the General Hospital of Patra
You will not qualify if you...
- Age under 18 years or over 75 years
- American Society of Anesthesiologists (ASA) physical status greater than III
- Allergy to nimodipine
- Inability to provide informed consent
- Known severe renal insufficiency
- Known severe bradyarrhythmia
- Daily opioid consumption in the 7 days before surgery
- Pain intensity greater than 5 on more than half of the days in the past month assessed by Numerical Rating Scale (0-10)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 1 hour before surgery until 24 hours after surgery
Participants receive a continuous intravenous infusion of nimodipine or placebo starting 1 hour prior to surgery, continuing during surgery, and up to 24 hours post-operation to manage pain and reduce anesthetic use.
1 surgical visit and continuous monitoring during hospital stay
Duration - Up to 72 hours postoperatively
Participants are monitored for pain intensity, opioid use, opioid-related side effects, bowel mobility, and length of hospital stay up to 72 hours post-surgery.
Regular assessments during hospital stay up to 3 days
Trial Site Locations
Total: 1 location
1
St. Andrews General Hospital of Patras, GREECE
Pátrai, Achaea, Greece, 263 32
Actively Recruiting
Research Team
M
Maria-Theodora Filou, MD
O
Ourania Patroni, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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