ClinConnect ClinConnect Logo
Search / Trial NCT06935708

Intrathecal Morphine Versus Epidural Analgesia for Open Colon Surgery

Launched by MERI MIRCETA · Apr 18, 2025

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Postoperative Pain Analgesia Epidural Intrathecal Morphine Laparotomy

ClinConnect Summary

This clinical trial is studying two different ways to manage pain after open surgery for colorectal cancer. Researchers want to compare intrathecal morphine, which is a single injection in the spine, to continuous epidural analgesia, where a tube delivers pain relief medicine through the spine. They hope to find out which method helps patients feel less pain while resting and moving after surgery. The trial will look at how effective each method is, as well as any side effects, such as low blood pressure or the need for extra pain medications.

To be eligible for this trial, participants should be between 18 and 80 years old and undergoing abdominal surgery for colorectal cancer. They should generally be in good health, without serious blood clotting issues or other medical conditions that might complicate the pain management methods. Participants can expect to be closely monitored during their recovery, with the aim of finding the best way to keep patients comfortable and help them heal after surgery. Overall, the study aims to improve pain management for patients, making their recovery smoother.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female patients with colorectal carcinoma undergoing laparoscopic abdominal surgery aged 18-80 years, ASA classification I-III, Body Mass Index (BMI) 15-35 kg/m2.
  • Exclusion Criteria:
  • abnormal coagulation function, defined as prothrombin time or activated partial prothrombin time above standard laboratory values or an international normalised ratio (INR) ≥1.4; or receiving ongoing therapeutic anticoagulation,
  • thrombocytopenia, defined as a platelet count \<80×10 9 L-1,
  • pre-existing skin infection at the neuraxial anesthesia puncture site,
  • pre-existing neurologic deficit, including peripheral neuropathy,
  • patients with dementia or other medical condition that includes communication difficulties,
  • patients with bradycardia (pulse \<50/min) or with conduction block (2nd or 3rd degree)
  • history of opioid abuse,
  • allergies to any of the drugs used in the study.
  • Additionally, patients converted from laparoscopy to laparotomy due to technical surgical issues, patients with postoperative surgical complications (need for revision) or if epidural catheter placement/spinal anesthesia is unsuccessful even after an attempt by a senior anesthesiologist will also be excluded.

About Meri Mirceta

Meri Mirceta is a dedicated clinical trial sponsor focused on advancing innovative therapeutic solutions across various medical fields. With a commitment to enhancing patient outcomes, the organization collaborates with leading researchers and healthcare professionals to design and conduct rigorous clinical studies. Meri Mirceta emphasizes ethical practices, regulatory compliance, and robust data management, ensuring that each trial contributes valuable insights to the scientific community. By prioritizing patient safety and efficacy, Meri Mirceta aims to accelerate the development of transformative treatments that address unmet medical needs.

Locations

Split, , Croatia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported