MorphinePhase 4SALMON-RARPNCT02924974
Spinal Morphine in Robotic Assisted Radical Prostatectomy
A Phase 4 study testing Morphine and Lidocaine in people with Morphine and Injections, Spinal, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Morphine, Injections, Spinal, Prostatectomy
- What is being tested?
- Morphine and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2016to 6 Aug 2018
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for Robot-Assisted Radical Prostatectomy
Who cannot join
- Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders)
- Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol)
- Conversion to an open procedure
- Post-operative ICU-admission
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy
Read the detailed description
This study is a randomized controlled trial. It will randomize 160 patients who are scheduled for Robot-Assisted Radical Prostatectomy. The intervention group will receive a single spinal injection of a bupivacaine (12,5 mg)/morphine(300 mcg) mixture. Controlgroup will receive a subcutaneous injection of lidocaïne for placebo purposes and an intravenous loading dose of morphine at the end of surgery.
Both groups will receive general anesthesia during surgery in a standardized fashion.
After the surgery, both groups will receive a Patient-Controlled Analgesia pump for post-operative pain control.
Primary outcome is patient satisfaction as measured by the Quality-of-Recovery-15 questionnaire. This questionnaire will be taken at baseline, day 2 and 1 week after surgery.
Secundary outcomes are morphine use per PCA, duration of hospital stay, side-effects and ease of surgery.
- Conditions
- Morphine, Injections, Spinal, Prostatectomy, Patient Satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | subcutaneous lidocaïne and intravenous loading dose of morphine Receives: Drug: Lidocaine |
| Intervention | Experimental | Spinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Quality of Recovery-15 questionnaire
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startSep 2016
- Primary completion25 May 2018
- Study completion6 Aug 2018
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 MorphineStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seppe Koopman, MD, PhD, Study chair, Maasstad ZiekenhuisAart Jan W Teunissen, MD, Study chair, Maasstad ZiekenhuisMark V Koning, MD, DESA, Principal investigator, Maasstad Ziekenhuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924974
- Sponsor's protocol ID
- L2015108
- Acronym
- SALMON-RARP
- Status last verified
- Mar 2018
- First submitted
- 29 Sep 2016
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Koning MV, de Vlieger R, Teunissen AJW, Gan M, Ruijgrok EJ, de Graaff JC, Koopman JSHA, Stolker RJ. The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial. Anaesthesia. 2020 May;75(5):599-608. doi: 10.1111/anae.14922. Epub 2019 Dec 17.
PubMed 31845316
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Morphine in Robotic Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02924974
- Acronym / sponsor ID
- SALMON-RARP / L2015108
- Conditions
- Morphine, Injections, Spinal, Prostatectomy, Patient Satisfaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 6 Aug 2018 (actual)
- First posted
- 5 Oct 2016 (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.
This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy
Detailed description
This study is a randomized controlled trial. It will randomize 160 patients who are scheduled for Robot-Assisted Radical Prostatectomy. The intervention group will receive a single spinal injection of a bupivacaine (12,5 mg)/morphine(300 mcg) mixture. Controlgroup will receive a subcutaneous injection of lidocaïne for placebo purposes and an intravenous loading dose of morphine at the end of surgery.
Both groups will receive general anesthesia during surgery in a standardized fashion.
After the surgery, both groups will receive a Patient-Controlled Analgesia pump for post-operative pain control.
Primary outcome is patient satisfaction as measured by the Quality-of-Recovery-15 questionnaire. This questionnaire will be taken at baseline, day 2 and 1 week after surgery.
Secundary outcomes are morphine use per PCA, duration of hospital stay, side-effects and ease of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: Lidocainesubcutaneous lidocaïne and intravenous loading dose of morphine |
| Intervention | Experimental | Drug: MorphineSpinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for Robot-Assisted Radical Prostatectomy
Key exclusion criteria (4 listed)
- Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders)
- Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol)
- Conversion to an open procedure
- Post-operative ICU-admission
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 |
|---|---|---|
| Morphinemixed with bupivacaine | Drug | Intervention |
| Lidocainesham procedure (s.c. lidocaïne) | Drug | Control |
Primary outcome
Patient satisfaction
Time frame: day 1
Quality of Recovery-15 questionnaire
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 7 Aug 2018.
- Derived from this study: PubMed 31845316Koning MV, de Vlieger R, Teunissen AJW, Gan M, Ruijgrok EJ, de Graaff JC, Koopman JSHA, Stolker RJ. The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial. Anaesthesia. 2020 May;75(5):599-608. doi: 10.1111/anae.14922. Epub 2019 Dec 17.
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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.
Seppe Koopman, MD, PhD study chair
Maasstad Ziekenhuis
Aart Jan W Teunissen, MD study chair
Maasstad Ziekenhuis
Mark V Koning, MD, DESA principal investigator
Maasstad Ziekenhuis
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 Morphine and Lidocaine in people with Morphine and Injections, Spinal, run by Maasstad Hospital at 1 site in Netherlands.
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 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 7 Aug 2018. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Patient satisfaction (time frame: day 1). 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 NCT02924974, 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 7 Aug 2018.