Postoperative PainPhase 4TCI-PCANCT02035709
Postoperative Pain Therapy With Hydromorphone Using TCI-PCA
A Phase 4 study testing Hydromorphone in people with Postoperative Pain, run by University of Erlangen-Nürnberg Medical School at 2 sites in Germany.
Trial summary
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2013to Apr 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age between 40 and 85 years, both genders
- 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 dosage for at least 14 days or if not used for premedication and surgery
- Administration of hydromorphone in the period between screening and surgery
- Severe hepatic or renal impairment in medical history
- BMI ≥35 kg/m²
- ASA ≥4
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Anesthesiology, University Hospital Erlangen
Erlangen, Bavaria, 91054
Department of Anesthesiology, University Hospital Erlangen
Erlangen, 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) After Elective Cardiac Surgery
Treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target concentrations in blood compared to conventional patient-controlled analgesia after planed cardiac surgery
- Conditions
- Postoperative Pain
- Being tested
- Hydromorphone
- Keywords
- Therapy
- 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 by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times and infusion speed.
| Study group | Role | What they receive |
|---|---|---|
| TCI-PCA | Active comparator | Intravenous Patient-Controlled Analgesia with Target-Controlled Infusion Receives: Drug: Hydromorphone |
| PCA | Active comparator | Intravenous Patient-Controlled Analgesia Receives: Drug: Hydromorphone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydromorphone Plasma Concentrations
Predictive accuracy of the "Erlanger pharmacokinetic model" of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage
Measured: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation
Secondary outcomes (1)
Numerical Rating Score
Comparison between hydromorphone TCI-PCA and conventional hydromorphone PCA during the early postoperative stage regarding analgetic efficiency
Measured: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 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 posted14 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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, Associate Professor, Principal investigator, Department of Anesthesiology, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02035709
- Sponsor's protocol ID
- TCI-PCA-001
- Other IDs
- 2013-002875-16
- Acronym
- TCI-PCA
- Status last verified
- Jul 2015
- First submitted
- 4 Dec 2013
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05.
PubMed 23958818Wehrfritz A, Ihmsen H, Fuchte T, Kim M, Kremer S, Weiss A, Schuttler J, Jeleazcov C. Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1168-1175. doi: 10.1097/EJA.0000000000001360.
PubMed 33009192Ihmsen H, Rohde D, Schuttler J, Jeleazcov C. External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy. Eur J Drug Metab Pharmacokinet. 2017 Feb;42(1):17-28. doi: 10.1007/s13318-015-0318-x.
PubMed 26797808
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. 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) After Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02035709
- Acronym / sponsor ID
- TCI-PCA / TCI-PCA-001
- Conditions
- Postoperative Pain
- Keywords
- Therapy
- 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
- Dec 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Jan 2014 (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 concentrations in blood compared to conventional patient-controlled analgesia after planed 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: HydromorphoneIntravenous Patient-Controlled Analgesia with Target-Controlled Infusion |
| PCA | Active comparator | Drug: HydromorphoneIntravenous Patient-Controlled Analgesia |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- Age between 40 and 85 years, both genders
- Scheduled for elective cardiac surgery involving thoracotomy and subsequent ICU stay
Key exclusion criteria (5 listed)
- Administration of other analgesics or sedatives, if not administered in stable dosage for at least 14 days or if not used for premedication and surgery
- Administration of hydromorphone in the period between screening and surgery
- Severe hepatic or renal impairment in medical history
- BMI ≥35 kg/m²
- 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 by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times and infusion speed. | Drug | PCA, TCI-PCA |
Primary outcome
Hydromorphone Plasma Concentrations
Time frame: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 17 hours after extubation
Predictive accuracy of the "Erlanger pharmacokinetic model" of hydromorphone administered via TCI, TCI-PCA and conventional PCA during the early postoperative stage
1 secondary outcome
Numerical Rating Score
Time frame: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 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 3 Jul 2015.
- Background: PubMed 23958818Jeleazcov C, Saari TI, Ihmsen H, Mell J, Frohlich K, Krajinovic L, Fechner J, Schuttler J. Population pharmacokinetic modeling of hydromorphone in cardiac surgery patients during postoperative pain therapy. Anesthesiology. 2014 Feb;120(2):378-91. doi: 10.1097/ALN.0b013e3182a76d05.
- Derived from this study: PubMed 33009192Wehrfritz A, Ihmsen H, Fuchte T, Kim M, Kremer S, Weiss A, Schuttler J, Jeleazcov C. Postoperative pain therapy with hydromorphone; comparison of patient-controlled analgesia with target-controlled infusion and standard patient-controlled analgesia: A randomised controlled trial. Eur J Anaesthesiol. 2020 Dec;37(12):1168-1175. doi: 10.1097/EJA.0000000000001360.
- Derived from this study: PubMed 26797808Ihmsen H, Rohde D, Schuttler J, Jeleazcov C. External Validation of a Recently Developed Population Pharmacokinetic Model for Hydromorphone During Postoperative Pain Therapy. Eur J Drug Metab Pharmacokinet. 2017 Feb;42(1):17-28. doi: 10.1007/s13318-015-0318-x.
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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, Associate Professor principal investigator
Department of Anesthesiology, University Hospital Erlangen
2 sites 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 in people with Postoperative Pain, run by University of Erlangen-Nürnberg Medical School at 2 sites 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 3 inclusion and 5 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 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hydromorphone Plasma Concentrations (time frame: Day 0 (Visit 2 on day of surgery): -1, 3, 30, 90, 91, 93, 95, 97, 100 min after start of hydromorphone infusion but before extubation; one sample each hour for the following 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 NCT02035709, which also lists 3 linked publications.
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 3 Jul 2015.