Acute Postoperative PainPhase 4NCT02483221
Postoperative Pain Therapy With Hydromorphone TCI-PCA vs. Morphine PCA
A Phase 4 study testing Hydromorphone and Morphine in people with Acute Postoperative Pain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Acute Postoperative Pain
- What is being tested?
- Hydromorphone and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to 1 Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
Who cannot join
- Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
- Administration of hydromorphone or morphine in the period between screening and surgery
- Severe hepatic or renal impairment in medical history
- BMI>= 35 ASA>= 4
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology, University Hospital Erlangen
Erlangen, Bavaria, 91054
About this study
Official title: Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery
- Conditions
- Acute Postoperative Pain
- Being tested
- Hydromorphone, Morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydromorphoneDrug
Hydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed.
MorphineDrug
Morphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed.
| Study group | Role | What they receive |
|---|---|---|
| TCI-PCA | Active comparator | Not described Receives: Drug: Hydromorphone |
| PCA | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Score
Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Measured: up to 17 hours after extubation
Secondary outcomes (3)
Modified Observer's Assessment of Alertness/Sedation Scale
Comparison of opioid induced sedation level between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Measured: up to 17 hours after extubation
Postoperative Nausea and Vomiting
Comparison of opioid associated nausea and vomiting between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Measured: day of surgery
Respiratory Frequency
Comparison of opioid induced respiratory depression between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
Measured: up to 17 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startApr 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Christian Jeleazcov, MD, MS, Principal investigator, Department of Anesthesiology, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483221
- Sponsor's protocol ID
- TCI-PCA-002
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2015
- Last updated
- 31 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ihmsen H, Schuttler J, Jeleazcov C. Pharmacokinetics of Morphine and Morphine-6-Glucuronide During Postoperative Pain Therapy in Cardiac Surgery Patients. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):249-263. doi: 10.1007/s13318-020-00663-z. Epub 2021 Feb 5.
PubMed 33547559
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Postoperative Pain Therapy With Hydromorphone Using Patient-Controlled Target-Controlled Infusion (TCI-PCA) vs. Patient-Controlled Analgesia (PCA) With Morphine After Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02483221
- Acronym / sponsor ID
- TCI-PCA-002
- Conditions
- Acute Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Apr 2015
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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.
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCI-PCA | Active comparator | Drug: Hydromorphone |
| PCA | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
Key exclusion criteria (4 listed)
- Administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery
- Administration of hydromorphone or morphine in the period between screening and surgery
- Severe hepatic or renal impairment in medical history
- BMI>= 35 ASA>= 4
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 |
|---|---|---|
| HydromorphoneHydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed. | Drug | TCI-PCA |
| MorphineMorphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed. | Drug | PCA |
Primary outcome
Numerical Rating Score
Time frame: up to 17 hours after extubation
Comparison of pain analgetic efficacy between hydromorphone TCI-PCA and conventional morphine PCA during the early postoperative stage
3 secondary outcomes
Modified Observer's Assessment of Alertness/Sedation Scale
Time frame: up to 17 hours after extubation
Postoperative Nausea and Vomiting
Time frame: day of surgery
Respiratory Frequency
Time frame: up to 17 hours after extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Derived from this study: PubMed 33547559Ihmsen H, Schuttler J, Jeleazcov C. Pharmacokinetics of Morphine and Morphine-6-Glucuronide During Postoperative Pain Therapy in Cardiac Surgery Patients. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):249-263. doi: 10.1007/s13318-020-00663-z. Epub 2021 Feb 5.
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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.
Christian Jeleazcov, MD, MS principal investigator
Department of Anesthesiology, University Hospital Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone and Morphine in people with Acute Postoperative Pain, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2017. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Rating Score (time frame: up to 17 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483221, which also lists 1 linked publication.
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 31 Jul 2017.