Renal Cell CarcinomaEMPONNCT01997788
The Intrathecal Morphine for Nephrectomy
A study testing The intrathecal morphine injection and Demerol on demand in people with Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- The intrathecal morphine injection and Demerol on demand
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2013to Oct 2013
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for the open nephrectomy
Who cannot join
- Patients with renal insufficiency
- Patients with coagulopathy
- History of any neurologic disorder
- History of recent infection in 2 weeks
- History of drug abuse
- Patients who cannot understand the usage of th intravenous patient-controlled analgesia
- Patients using opioids due to the chronic pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.
Read the detailed description
The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.
- Conditions
- Renal Cell Carcinoma
- Being tested
- The intrathecal morphine injection, The intravenous patient-controlled analgesia, Demerol on demand
- Keywords
- Injection, Spinal, Morphine, Analgesia, Patient-Controlled, Pain, Postoperative, Combined Modality Therapy, Nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The intrathecal morphine injectionDrug
A single injection of morphine intrathecally
The intravenous patient-controlled analgesiaDrug
The intravenous injection of morphine using the patient-controlled analgesia machine
Demerol on demandDrug
Demerol 25 mg intravenously when pain scores more than 5.
| Study group | Role | What they receive |
|---|---|---|
| The ITM group | Experimental | The postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. Receives: Drug: The intrathecal morphine injection; Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand |
| The IV-PCA group | Placebo comparator | The postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. Receives: Drug: The intravenous patient-controlled analgesia; Drug: Demerol on demand |
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of pain at 24 hours after surgery
The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.
Measured: at postoperatively 24 hours
Secondary outcomes (3)
The consumption of analgesics
The total amount of opioids (IV morphine) used for 24 hours after surgery will be recorded and compared.
Measured: at postoperatively 24 hours
The consumption of intraoperative opioids
The total amount of intraoperative opioids (IV remifentanil) will be recorded and compared.
Measured: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
The side effects of opioids after surgery
Any side effects of opioids including nausea, vomiting, dizziness, sedation, headache, pruritus and respiratory depression will be recorded.
Measured: During 72 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startAug 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deok Man Hong, Seoul National University Hospital
- Investigators
- Deok-Man Hong, PhD, Study director, Seoul National University of Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997788
- Sponsor's protocol ID
- ITMPKidney
- Acronym
- EMPON
- Status last verified
- Jul 2015
- First submitted
- 10 Sep 2013
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- The Efficacy of Intrathecal Morphine in Patients Undergoing Open Nephrectomy
- ClinicalTrials.gov ID
- NCT01997788
- Acronym / sponsor ID
- EMPON / ITMPKidney
- Conditions
- Renal Cell Carcinoma
- Keywords
- Injection, Spinal, Morphine, Analgesia, Patient-Controlled, Pain, Postoperative, Combined Modality Therapy, Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Nov 2013 (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.
To evaluate the efficacy and the safety of the intrathecal morphine injection in the open nephrectomy.
Detailed description
The open nephrectomy is the treatment of choice for live donor kidney transplantation and renal cell carcinoma. The incision for the nephrectomy causes severe postoperative pain. A single dose of intrathecal morphine(ITM) has been used for the postoperative pain of prostatectomy, transurethral resection of the prostate and hepatectomy. The effect of ITM for open nephrectomy has not been studied. Therefore, this prospective, randomized study will evaluate the efficacy and safety of a single 50 mcg dose of ITM added to intravenous patient controlled analgesia(IV-PCA), comparing to IV-PCA alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The ITM group | Experimental | Drug: The intrathecal morphine injection, Drug: The intravenous patient-controlled analgesia, Drug: Demerol on demandThe postoperative pain management includes both the intrathecal morphine injection and the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. |
| The IV-PCA group | Placebo comparator | Drug: The intravenous patient-controlled analgesia, Drug: Demerol on demandThe postoperative pain management includes only the intravenous patient-controlled analgesia. Demerol on demand will be injected intravenously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for the open nephrectomy
Key exclusion criteria (7 listed)
- Patients with renal insufficiency
- Patients with coagulopathy
- History of any neurologic disorder
- History of recent infection in 2 weeks
- History of drug abuse
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 |
|---|---|---|
| The intrathecal morphine injectionA single injection of morphine intrathecally | Drug | The ITM group |
| The intravenous patient-controlled analgesiaThe intravenous injection of morphine using the patient-controlled analgesia machine | Drug | The ITM group, The IV-PCA group |
| Demerol on demandDemerol 25 mg intravenously when pain scores more than 5. | Drug | The ITM group, The IV-PCA group |
Primary outcome
The evaluation of pain at 24 hours after surgery
Time frame: at postoperatively 24 hours
The doctor blinded to the investigation will visit patients. The pain will be assessed at rest and at coughing using visual analogue scale.
3 secondary outcomes
The consumption of analgesics
Time frame: at postoperatively 24 hours
The consumption of intraoperative opioids
Time frame: From the induction of anesthesia till the emergence of anesthesia, an expected average of 4 hours
The side effects of opioids after surgery
Time frame: During 72 hours after the end of surgery
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.
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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.
Deok-Man Hong, PhD study director
Seoul National University of Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The intrathecal morphine injection and Demerol on demand in people with Renal Cell Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 7 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 1 site in South Korea. 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.
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?
The evaluation of pain at 24 hours after surgery (time frame: at postoperatively 24 hours). 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 3 Jul 2015.