NephrectomyPhase 2NCT03428633
Thoracic Paravertebral Blocks in Open Nephrectomy
A Phase 2 study testing Ropivacaine and Morphine in people with Nephrectomy and Analgesia, run by Asklepieion Voulas General Hospital at 1 site in Greece.
Trial summary
60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be… Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Nephrectomy, Analgesia
- What is being tested?
- Ropivacaine and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 9 Mar 2018to 1 Feb 2023
- Phase
- Phase 2
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for open nephrectomy
Who cannot join
- Previous operation on same kidney
- Contraindication of paravertebral block or any of the agents used in the protocol
- BMI above 32
- Any concurrent malignancy not cured
- Serious psychiatric, mental and cognitive disorders
- Block failure
- Chronic pain
- Severe kidney disfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.
60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.
- Conditions
- Nephrectomy, Analgesia
- Being tested
- Ropivacaine, Morphine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Paravertebral block using ropivacaine preoperatively and postoperatively
MorphineDrug
Morphine intraoperatively and postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Thoracic paravertebral block using ropivacaine Receives: Drug: Ropivacaine |
| Group B | Active comparator | Morphine IV Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Measured: 48 hours
Oxidative stress - lactic acid (mmol/L)
Measured: 24 hours
Oxidative stress - superoxide dismutase (units/ml)
Measured: 24 hours
Oxidative stress - malondialdehyde (nmol/mg protein)
Measured: 24 hours
Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)
Measured: 24 hours
Secondary outcomes (5)
Complications
Measured: 48 hours
Patient satisfaction
Patients asked whether they would choose the same anaesthetic management in a future operation: Yes/No
Measured: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed
Measured: 7 days
Intestinal function
Time of first passing of rectal gas, reported by the patient
Measured: 7 days
Chronic pain
Using of Graded Chronic Pain Scale (GCPS) Grade 0: No pain in prior 6 months Grade 1: Low Intensity - Low Disability Grade II: High Intensity Characteristic Pain Intensity - Low Disability Grade III: High Disability - Moderately Limiting Grade IV: High Disability - Severely Limiting
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start9 Mar 2018
- Primary completion1 Feb 2021
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrectomyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asklepieion Voulas General Hospital
- Sponsor type
- Other government
- Collaborators
- Michail Tsagkaris, Chryssoula Staikou, Ioannis Karavokyros
- Responsible party
- Principal investigator, Alexandros Makris, Asklepieion Voulas General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428633
- Sponsor's protocol ID
- AsklepieionVGH
- Status last verified
- Oct 2023
- First submitted
- 1 Feb 2018
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Blocks in Open Nephrectomy. A Prospective, Randomized Study of Block Efficacy and Influence on Oxidative Stress and Patient Outcome.
- ClinicalTrials.gov ID
- NCT03428633
- Acronym / sponsor ID
- AsklepieionVGH
- Conditions
- Nephrectomy, Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asklepieion Voulas General HospitalOther government
- Collaborators
- Michail Tsagkaris, Chryssoula Staikou, Ioannis Karavokyros
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 9 Feb 2018 (actual)
- 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.
60 patients ASA I-III, undergoing open nephrectomy will be randomly assigned into one of two groups, namely group A (n=30), where a thoracic paravertebral block will be performed preoperatively and a paravertebral catheter for continuous and patient controlled bolus local anesthetic (ropivacaine) doses will be inserted and group B (n=30) where morphine IV will be administered at the beginning and the end of operation and postoperatively through patient controlled IV doses. NRS scores in static and dynamic conditions, complications, patient satisfaction, oxidative stress (through lactic acid, superoxide dismutase, malondialdehyde) and NGAL pre- and postoperatively, will be recorded.
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 |
|---|---|---|
| Group A | Active comparator | Drug: RopivacaineThoracic paravertebral block using ropivacaine |
| Group B | Active comparator | Drug: MorphineMorphine IV |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Physical status according to American Society of Anesthesiologists (ASA) I-III
- Patients scheduled for open nephrectomy
Key exclusion criteria (8 listed)
- Previous operation on same kidney
- Contraindication of paravertebral block or any of the agents used in the protocol
- BMI above 32
- Any concurrent malignancy not cured
- Serious psychiatric, mental and cognitive disorders
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 |
|---|---|---|
| RopivacaineParavertebral block using ropivacaine preoperatively and postoperatively | Drug | Group A |
| MorphineMorphine intraoperatively and postoperatively | Drug | Group B |
Primary outcome
Postoperative pain
Time frame: 48 hours
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Oxidative stress - lactic acid (mmol/L)
Time frame: 24 hours
Oxidative stress - superoxide dismutase (units/ml)
Time frame: 24 hours
Oxidative stress - malondialdehyde (nmol/mg protein)
Time frame: 24 hours
Oxidative stress - neutrophil gelatinase-associated lipocalin (NGAL) (ng/ml)
Time frame: 24 hours
5 secondary outcomes
Complications
Time frame: 48 hours
Patient satisfaction
Time frame: 48 hours
Patient mobilization
Time frame: 7 days
Intestinal function
Time frame: 7 days
Chronic pain
Time frame: 6 months
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 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivacaine and Morphine in people with Nephrectomy and Analgesia, run by Asklepieion Voulas General Hospital at 1 site in Greece.
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 8 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 13 Oct 2023. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 pain (time frame: 48 hours). The study lists 5 primary outcomes in all. 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 13 Oct 2023.