NCT07048522

Perioperative Intravenous Nimodipine Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Ioannina · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The role of perioperative IV administration of nimodipine, an L-type calcium channel antagonist which is capable of crossing the blood-brain barrier, on peri-operative opioid and anesthetics requirements, pain intensity, opioid-related side effects and early postoperative bowel mobility in patients undergoing surgical treatment for bowel cancer with open radical colectomy remains scarcely explored. A prospective double-blind, randomized controlled trial investigating the effect of perioperative IV administration of nimodipine in patients undergoing open colectomy for cancer treatment is therefore conducted.

Detailed description

Background with aim: Acute postoperative pain is still of major clinical concern for a large number of patients undergoing surgery worldwide. Despite advances in pain management strategies, many patients continue to suffer from moderate-to-severe pain during the early postoperative period, while opioids are still largely over-prescribed. Not effectively and especially unrelieved pain can result in decreased patient satisfaction, increased morbidity, prolonged hospital length-of-stay and increased risk of persistent pain. Furthermore, effective treatment of acute postoperative pain using opioid analgesics remains the core treatment for postoperative pain. Although the potential benefits of opioid therapy for acute pain lead to a short-term pain control there are several potential severe side-effects associated with opioid use which may outweigh the benefits including sedation, nausea, vomiting, constipation especially in bowel surgery, and the risk of long-term use. Although various non-opioid drugs have been investigated over the past decades, information regarding L-type calcium channel blockers in acute postoperative pain is limited. In this respect, the perioperative use of nimodipine, a drug which furthermore crosses the blood-brain barrier and has direct effects on the Central Nernous System (CNS) could potentiate the effects of opioid analgesia and intraoperative anesthetic requirements, providing improved analgesia and potentially reduce for opioids in the perioperative period. Therefore, the investigators decided to carry out the present study with the aim to examine the analgesic efficacy and safety of perioperatively administered IV nimodipine in patients undergoing open colectomy on perioperative opioid and anesthetic consumption, pain intensity, opioid-related side effects and early postoperative bowel mobility. Method: A power analysis based on a previous preliminary study using IV nimodipine for medium risk general surgery (open cholecystectomy) showed that 9 patients would provide a power greater than 0.9 (α = 0.05) for detection of differences of pain scores and cumulative opioid consumption over time (up to 48 h). Therefore, 40 patients undergoing open colectomy will be included in this prospective, randomized, double-blind, controlled trial with two arms: an intervention arm (IV nimodipine 4 mg/h starting 1h prior to surgery until one h after the start of surgery, followed by 2 mg/h until 24 h post-operation) and a control arm (isotonic saline 20 ml/ h 1h prior to and until one h after start of surgery, followed by 10 ml/h until 24 h post-operation). The study is approved by the local hospital scientific board (#18-4\_2024-12-05). Hypothesis: The investigators hypothesize that perioperative intravenous administration of nimodipine, an L-type calcium channel antagonist, will be effective in reducing intraoperative anesthetic requirements, as well as intra- and postoperative opioid requirements, as well as postoperative pain intensity and opioid-related side effects.

Conditions

• Colectomy
• Open Surgery
• Pain
• Pain, Postoperative
• Pain, Acute

Interventions

Type	Name	Description
DRUG	Nimodipine	A continuous dose of 4 mg/h (20 ml/h) of nimodipine solution will be administered continuously 1 h prior to start of operation until 1 h after start of the procedure. • The nimodipine dose will be then reduced to 2 mg/h (10 ml/h) until 24 hrs after the end of the procedure.
DRUG	Isotonic Saline	A continuous dose of 20 ml/h of normal saline solution will be administered continuously one (1) h prior to start of operation until 1 h after start of the procedure. The normal saline dose will be then reduced to 10 ml/h until 24 h after the end of the procedure.

Timeline

• Start date: 2025-05-19
• Primary completion: 2026-05-19
• Completion: 2027-02-15
• First posted: 2025-07-02
• Last updated: 2025-07-02

Locations

1 site across 1 country: Greece