Pre- and Postoperative AnalgesiaPhase 2/3ASANCT02030717
Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
A Phase 2/3 study testing klonidin and epidural anesthesia in people with Pre- and Postoperative Analgesia and Spinal Anesthesia, run by Umeå University at 1 site in Sweden.
Trial summary
The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pre- and Postoperative Analgesia, Spinal Anesthesia, Renal Cell Carcinoma
- What is being tested?
- klonidin and epidural anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to May 2015
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma
Who cannot join
- patients in ASA score IV-V,
- patients with advanced tumour thrombus in vena cava inferior,
- patients with high risk for bleeding
- patients with previous chronic pain symptoms
- patients having drug abuse
- patients having cognitive deficiencies or dementia disease
Show all 9Show fewer
- patients with any contraindication of either spinal or epidural anesthesia
- patients younger than 18 years and pregnant woman
- patients having a weight less than 45 kg or weight over 120 kg
Trial locations and contacts
1 site in 1 country.
About this study
The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.
- Being tested
- klonidin, epidural anesthesia
- Keywords
- Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
klonidinDrug
Also called Brand name: Duraclon - FDA Apl No (NDA) 020615.
spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age
epidural anesthesiaDrug
epidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml
| Study group | Role | What they receive |
|---|---|---|
| Spinal anesthesia | Experimental | The drugs used in the spinal injection are: 12 mg bupivacain, 160 ug morfin och klonidin( < 60 years 75 ug, 60 - 85 years old 60 ug and older than 85 years 45 ug) Receives: Drug: klonidin |
| Epidural anesthesia | Active comparator | Epidural anesthesia patients group gets an epidural catheter at level Th 8- 10 with per- and postoperative infusion with a routine mixture of: bupivacain 1 mg/ml, fentanyl 1 ug/ml, and adrenalin 1 ug/ml) until termination. Receives: Drug: epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative mobilisation index
Using a number of variables an index of mobilisation has been created; eg pain (10 graded scale), malaise, intravenous substitution, eating in dining room, Walking outside ward room, passage of stool, carrying urinary bladder catheter, can mobilise out of bed without help
Measured: within the first 30 days (plus or minus 5 days) after surgery
Secondary outcomes (1)
time of hospitalization
time in hospital after surgery until discharge
Measured: within the first 15 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Pre- and Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Umeå
- Responsible party
- Sponsor
- Investigators
- Borje Ljungberg, MD, PhD, Study chair, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030717
- Sponsor's protocol ID
- Dnr 151:2010/81099
- Other IDs
- 2008-001491-77, 2008
- Acronym
- ASA
- Status last verified
- Jun 2015
- First submitted
- 7 Jan 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thurm M, Hultin M, Johansson G, Dahlin BI, Winso O, Ljungberg B. Spinal anaesthesia with clonidine: pain relief and earlier mobilisation after open nephrectomy - a randomised clinical trial. J Int Med Res. 2022 Sep;50(9):3000605221126883. doi: 10.1177/03000605221126883.
PubMed 36177827
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Spinal Anesthesia Compared With Traditional Epidural Anesthesia Concerning Peroperative and Postoperative Pain After Open Nephrectomy in Patients With Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02030717
- Acronym / sponsor ID
- ASA / Dnr 151:2010/81099
- Keywords
- Spinal anesthesia, Epidural anesthesia, Klonidin, renal cell carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Umeå
- Study start
- Feb 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 8 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.
The study aim to study whether spinal anesthesia (using: bupivacain, morfin och klonidin) can be better than epidural anesthesia during and after open surgery for renal cell carcinoma. Per- and postoperative pain after spinal anesthesia with klonidin can be reduced and, thus, shorten the hospital stay and rehabilitation of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal anesthesia | Experimental | Drug: klonidinThe drugs used in the spinal injection are: 12 mg bupivacain, 160 ug morfin och klonidin( < 60 years 75 ug, 60 - 85 years old 60 ug and older than 85 years 45 ug) |
| Epidural anesthesia | Active comparator | Drug: epidural anesthesiaEpidural anesthesia patients group gets an epidural catheter at level Th 8- 10 with per- and postoperative infusion with a routine mixture of: bupivacain 1 mg/ml, fentanyl 1 ug/ml, and adrenalin 1 ug/ml) until termination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients in ASA score I - III, planned to be treated with open radical nephrectomy or nephron-sparing surgery having renal cell carcinoma
Key exclusion criteria (9 listed)
- patients in ASA score IV-V,
- patients with advanced tumour thrombus in vena cava inferior,
- patients with high risk for bleeding
- patients with previous chronic pain symptoms
- patients having 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 |
|---|---|---|
| klonidinAlso: Brand name: Duraclon - FDA Apl No (NDA) 020615.spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age | Drug | Spinal anesthesia |
| epidural anesthesiaepidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml | Drug | Epidural anesthesia |
Primary outcome
postoperative mobilisation index
Time frame: within the first 30 days (plus or minus 5 days) after surgery
Using a number of variables an index of mobilisation has been created; eg pain (10 graded scale), malaise, intravenous substitution, eating in dining room, Walking outside ward room, passage of stool, carrying urinary bladder catheter, can mobilise out of bed without help
1 secondary outcome
time of hospitalization
Time frame: within the first 15 days after 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 4 Jun 2015.
- Derived from this study: PubMed 36177827Thurm M, Hultin M, Johansson G, Dahlin BI, Winso O, Ljungberg B. Spinal anaesthesia with clonidine: pain relief and earlier mobilisation after open nephrectomy - a randomised clinical trial. J Int Med Res. 2022 Sep;50(9):3000605221126883. doi: 10.1177/03000605221126883.
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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.
Borje Ljungberg, MD, PhD study chair
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing klonidin and epidural anesthesia in people with Pre- and Postoperative Analgesia and Spinal Anesthesia, run by Umeå University at 1 site in Sweden.
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 9 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 4 Jun 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 Sweden. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
postoperative mobilisation index (time frame: within the first 30 days (plus or minus 5 days) after surgery). 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 NCT02030717, 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 4 Jun 2015.