MorphineNCT07238179
Side Effects of a Single Shot Intrathecal Morphine in Clinical Practice, a Retrospective Analysis
An observational study of Morphine and Morphine Adverse Reaction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Morphine, Morphine Adverse Reaction, Morphine Induced Pruritis
- What is being tested?
- Intrathecal Morphine
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2021to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any patient receiving intrathecal morphine and combined with general anesthesia.
Who may be able to join
- Patients undergoing surgery and receiving general anaesthesia with preoperative administration of a single shot of ITM.
Who cannot join
- Patients who are less than 18 years old.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Most patients undergoing invasive procedures experience postoperative pain. The definition of pain is described as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Postoperative incisional pain is a unique and common form of acute pain. Recent studies demonstrate that about 50-70% of patients experience moderate to severe pain after surgery indicating that postoperative pain remains poorly treated.
Mismanagement of acute postoperative pain compromises patient recovery by increasing morbidity and delaying recovery. Therefore, adequate pain treatment is crucial. Steps for formulating a multimodal regimen consider both non pharmacologic and pharmacologic therapies. Opioids are considered a staple in the management of acute postoperative pain. Opioid analgesics embody a wide range of medicinal products that share the ability to relieve acute severe pain by acting on the opioid receptors. There has been a significant increase in the number of opioid analgesics, and they differ in their chemical composition and route of administration (oral, intravenous, subcutaneous, intramuscular, topical, transmucosal, transdermal, neuraxial). Despite their effectiveness in pain relief, opioids are also associated with side effects, including physical dependence and respiratory depression. Consequently, researchers have been exploring alternative methods of opioid administration to minimise the risk of these side effects, one of which is intrathecal opioid delivery.
Since their introduction in the 1970s, intrathecal opioids have been extensively utilised and have gained significant popularity for their efficacy in the management of postoperative pain. Intrathecal morphine (ITM) refers to the single injection of morphine into the subarachnoid space between two lumbar vertebrae. It can be used in combination with general anaesthesia, as adjuncts to intrathecal local anaesthetics or alone. It is rather easy to administer and when used as a single shot technique, it can provide long-lasting effective postoperative analgesia. Moreover, it can decrease systemic opioid consumption and potentially facilitates enhanced recovery due to optimised pain management and faster mobilisation.
Despite its potential, the use of ITM is restrained in daily clinical practice due to the concerns about the potential side effects, including postoperative nausea and vomiting (PONV), pruritus, urinary retention, sedation and respiratory depression. Especially the latter is a reason for clinicians to be reluctant to the use of ITM. At present, data regarding the incidence and severity of side effects following ITM is relatively limited. Respiratory depression is one of the most serious side effects and appears to be dose dependent. Since lower doses of ITM are currently being used, it occurs less frequently than in the past. Respiratory depression has no clear definition in the literature and can be caused by several factors, which makes it challenging to investigate. Studies report an incidence ranging from 0 to 3.4%, depending on the dose of ITM. A single shot up to 150µg seems to be safe and the risk of respiratory depression equals that of systemic opioids in this dosage. A higher amount of ITM may increase the risk of respiratory depression, without necessarily improving analgesia.
- Conditions
- Morphine, Morphine Adverse Reaction, Morphine Induced Pruritis, Nausea and Vomiting, Postoperative, Analgesia, Spinal Analgesia
- Being tested
- Intrathecal Morphine
- Medical subject headings
- Postoperative Nausea and Vomiting, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal MorphineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine | Not described Receives: Drug: Intrathecal Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours postoperatively
Secondary outcomes (3)
Number of patients reporting pruritus within the first 24 hours postoperatively
Based on the electronic health records we will identify whether there is a reporting of patients experiencing pruritus or received treatment for pruritus (administration of antihistamines).
Measured: First 24 hours postoperatively
Number of patients reporting clinically relevant postoperative nausea and vomiting within the first 24 hours postoperatively
Based on the electronic health record, we will identify patients with PONV numeric rating scale (NRS) score >3 (on a scale from 0-10) and/or receiving additional treatment with anti-emetics.
Measured: 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.
Using the electronic health record we will identify the patients requiring bladder catheterization during their stay on the post-anesthesia care unit or on the normal ward up till 24 hours after surgery.
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Mar 2021
- Primary completion31 Dec 2025
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MorphineStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny F Hoogma, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238179
- Sponsor's protocol ID
- s70568
- Status last verified
- Apr 2026
- First submitted
- 24 Sep 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudoanonymised data will be available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side Effects of a Single Shot Intrathecal Morphine in Clinical Practice, a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07238179
- Acronym / sponsor ID
- s70568
- Conditions
- Morphine, Morphine Adverse Reaction, Morphine Induced Pruritis, Nausea and Vomiting, Postoperative, Analgesia, Spinal Analgesia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Most patients undergoing invasive procedures experience postoperative pain. The definition of pain is described as an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage. Postoperative incisional pain is a unique and common form of acute pain. Recent studies demonstrate that about 50-70% of patients experience moderate to severe pain after surgery indicating that postoperative pain remains poorly treated.
Mismanagement of acute postoperative pain compromises patient recovery by increasing morbidity and delaying recovery. Therefore, adequate pain treatment is crucial. Steps for formulating a multimodal regimen consider both non pharmacologic and pharmacologic therapies. Opioids are considered a staple in the management of acute postoperative pain. Opioid analgesics embody a wide range of medicinal products that share the ability to relieve acute severe pain by acting on the opioid receptors. There has been a significant increase in the number of opioid analgesics, and they differ in their chemical composition and route of administration (oral, intravenous, subcutaneous, intramuscular, topical, transmucosal, transdermal, neuraxial). Despite their effectiveness in pain relief, opioids are also associated with side effects, including physical dependence and respiratory depression. Consequently, researchers have been exploring alternative methods of opioid administration to minimise the risk of these side effects, one of which is intrathecal opioid delivery.
Since their introduction in the 1970s, intrathecal opioids have been extensively utilised and have gained significant popularity for their efficacy in the management of postoperative pain. Intrathecal morphine (ITM) refers to the single injection of morphine into the subarachnoid space between two lumbar vertebrae. It can be used in combination with general anaesthesia, as adjuncts to intrathecal local anaesthetics or alone. It is rather easy to administer and when used as a single shot technique, it can provide long-lasting effective postoperative analgesia. Moreover, it can decrease systemic opioid consumption and potentially facilitates enhanced recovery due to optimised pain management and faster mobilisation.
Despite its potential, the use of ITM is restrained in daily clinical practice due to the concerns about the potential side effects, including postoperative nausea and vomiting (PONV), pruritus, urinary retention, sedation and respiratory depression. Especially the latter is a reason for clinicians to be reluctant to the use of ITM. At present, data regarding the incidence and severity of side effects following ITM is relatively limited. Respiratory depression is one of the most serious side effects and appears to be dose dependent. Since lower doses of ITM are currently being used, it occurs less frequently than in the past. Respiratory depression has no clear definition in the literature and can be caused by several factors, which makes it challenging to investigate. Studies report an incidence ranging from 0 to 3.4%, depending on the dose of ITM. A single shot up to 150µg seems to be safe and the risk of respiratory depression equals that of systemic opioids in this dosage. A higher amount of ITM may increase the risk of respiratory depression, without necessarily improving analgesia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine | – | Drug: Intrathecal Morphine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient receiving intrathecal morphine and combined with general anesthesia.
Key inclusion criteria (1 listed)
- Patients undergoing surgery and receiving general anaesthesia with preoperative administration of a single shot of ITM.
Key exclusion criteria (1 listed)
- Patients who are less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal MorphineThe 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. | Drug | Intrathecal morphine |
Primary outcome
Incidence of respiratory depression in the first 24 hours postoperatively
Time frame: 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.
3 secondary outcomes
Number of patients reporting pruritus within the first 24 hours postoperatively
Time frame: First 24 hours postoperatively
Number of patients reporting clinically relevant postoperative nausea and vomiting within the first 24 hours postoperatively
Time frame: 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.
Time frame: First 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. Pseudoanonymised data will be available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny F Hoogma, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morphine and Morphine Adverse Reaction, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory depression in the first 24 hours postoperatively (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.