Side Effects of a Single Shot Intrathecal Morphine in Clinical Practice, a Retrospective Analysis

NCT07238179 | Active Not Recruiting

• 1 other identifier: s70568
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

ITM has the potential to be a powerful tool for multimodal postoperative pain management, understanding, preventing and managing its side effects is crucial for upturn of patient safety and comfort. This retrospective audit will therefore be focused on the most reported side effects in daily clinical practice in patients having received ITM. The results of this study may lead to new insights into the clinically relevant risk-benefit balance of ITM and will contribute to the optimisation of its use in clinical practice.

Conditions

Morphine; Morphine Adverse Reaction; Morphine Induced Pruritis; Nausea and Vomiting, Postoperative; Analgesia; Spinal Analgesia

Outcome Measures

Primary Outcomes (1)

• Incidence of respiratory depression in the first 24 hours postoperatively

  Incidence of respiratory depression defined as followed: * Prolonged intubation and ventilation (\>2 hours) despite adequate reversal of neuromuscular block. OR * Support of ventilation following extubation with either non-invasive or invasive ventilation. OR * Primary respiratory acidosis (in an extubated patient). OR * Reporting of bradypnea, respiratory rate \< 8/min.

  24 hours postoperatively

Secondary Outcomes (3)

• Number of patients reporting pruritus within the first 24 hours postoperatively

  First 24 hours postoperatively

• Number of patients reporting clinically relevant postoperative nausea and vomiting within the first 24 hours postoperatively

  First 24 hours postoperatively

• Incidence of patient requiring urinary retention bladder catheterization during their stay on the post-anesthesia care unit or up to 24 hours postoperatively.

  First 24 hours postoperatively

Study Arms (1)

Intrathecal morphine

Drug: Intrathecal Morphine

Interventions

Intrathecal Morphine DRUG

The administration of intrathecal morphine (2µg/kg, with a maximum of 150-200µg) according to standard practice in a variety of surgical procedures. In addition, patients of 2 RCT using 4 or 5µg/kg (max 400 or 500µg), will also be included.

Intrathecal morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient receiving intrathecal morphine and combined with general anesthesia.

You may qualify if:

• Patients undergoing surgery and receiving general anaesthesia with preoperative administration of a single shot of ITM.

You may not qualify if:

• Patients who are less than 18 years old.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Danny F Hoogma, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 20, 2025
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication until 3 years later
• Access Criteria: Contact the PI

Locations

BE (1)