Pain, PostoperativeNCT03529201
QLB After Nephrectomy
A study testing QLB, PCA and GA in people with Pain, Postoperative and Chronic Postoperative Pain, run by Medical University of Lublin at 2 sites in Poland.
Trial summary
Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Chronic Postoperative Pain
- What is being tested?
- QLB, PCA and GA
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesPoland
- Study dates
- 7 May 2018to 25 Aug 2019
- 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
- obtained consent
- nephrectomy procedure
Who cannot join
- coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
Bialystok, 15-950
Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów
Rzeszów, 35-055
About this study
Official title: Effectiveness of Quadratus Lumborum Block After Nephrectomy
Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).
Read the detailed description
Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.
Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).
Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.
Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.
At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
- Conditions
- Pain, Postoperative, Chronic Postoperative Pain
- Being tested
- QLB, PCA, GA, Oxycodone, Sevoflurane
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLBProcedure or surgery
On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)
PCADevice
Patient-controlled analgesia
GAProcedure or surgery
General anesthesia
OxycodoneDrug
administered by PCA
SevofluraneDrug
Inhalational anesthetic during GA
FentanylDrug
painkiller during GA
RocuroniumDrug
muscle relaxant during GA
| Study group | Role | What they receive |
|---|---|---|
| QLB | Experimental | At the end of surgery, QLB with ropivacaine will be done on the side of the operation. Receives: Procedure: QLB; Device: PCA; Procedure: GA; Drug: Oxycodone; Drug: Sevoflurane; Drug: Fentanyl; Drug: Rocuronium |
| Control | Experimental | Standard care. No regional blocks. Receives: Device: PCA; Procedure: GA; Drug: Oxycodone; Drug: Sevoflurane; Drug: Fentanyl; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of oxycodone
Overall use of oxycodone administered by PCA pump will be assessed.
Measured: 24 hours after the end of surgery.
Secondary outcomes (2)
Pain intensity
Pain intensity measured on VAS scale at the 2, 4, 8, 12, 24 hours. VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all.
Measured: 24 hours after the end of surgery
Chronic pain
Chronic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain.
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start7 May 2018
- Primary completion28 Feb 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated to one of the study arms: QLB or control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów, Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529201
- Sponsor's protocol ID
- KE-0254/328/2017
- Status last verified
- Nov 2023
- First submitted
- 1 May 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Quadratus Lumborum Block After Nephrectomy
- ClinicalTrials.gov ID
- NCT03529201
- Acronym / sponsor ID
- KE-0254/328/2017
- Conditions
- Pain, Postoperative, Chronic Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Department of Anesthesiology and Intensive Care, F. Chopin Hospital in Rzeszów, Department of Anesthesiology and Intensive Care, J. Śniadecki Hospital in Białystok
- Study start
- 7 May 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 18 May 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.
Oxycodone consumption and postoperative pain intensity in patients undergoing nephrectomy procedures. Of all study participants, 50% will obtain quadratus lumborum block (QLB).
Detailed description
Patients undergoing nephrectomy procedures will be allocated to one of the study arms. At the end of an operation, still under general anesthesia, 50% patients will obtain QLB with ropivacaine.
Ultrasound-guided QLB will be performed on the side of surgery with 0.375% ropivacaine solution (0.2 mL per kg).
Every patient will get patient-controlled analgesia pump with oxycodone in the postoperative period.
Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of the operation. 24 -hours period.
At the 1, 3, 6 months patients will be interviewed by phone to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated to one of the study arms: QLB or control group.
| Arm | Type | Receives |
|---|---|---|
| QLB | Experimental | Procedure: QLB, Device: PCA, Procedure: GA, Drug: Oxycodone, Drug: Sevoflurane, Drug: Fentanyl, Drug: RocuroniumAt the end of surgery, QLB with ropivacaine will be done on the side of the operation. |
| Control | Experimental | Device: PCA, Procedure: GA, Drug: Oxycodone, Drug: Sevoflurane, Drug: Fentanyl, Drug: RocuroniumStandard care. No regional blocks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- obtained consent
- nephrectomy procedure
Key exclusion criteria (1 listed)
- coagulopathy allergy to local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs
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 |
|---|---|---|
| QLBOn the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg) | Procedure or surgery | QLB |
| PCAPatient-controlled analgesia | Device | Control, QLB |
| GAGeneral anesthesia | Procedure or surgery | Control, QLB |
| Oxycodoneadministered by PCA | Drug | Control, QLB |
| SevofluraneInhalational anesthetic during GA | Drug | Control, QLB |
| Fentanylpainkiller during GA | Drug | Control, QLB |
| Rocuroniummuscle relaxant during GA | Drug | Control, QLB |
Primary outcome
Total consumption of oxycodone
Time frame: 24 hours after the end of surgery.
Overall use of oxycodone administered by PCA pump will be assessed.
2 secondary outcomes
Pain intensity
Time frame: 24 hours after the end of surgery
Chronic pain
Time frame: 6 months after the 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 24 Nov 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QLB, PCA and GA in people with Pain, Postoperative and Chronic Postoperative Pain, run by Medical University of Lublin at 2 sites in Poland.
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 1 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 24 Nov 2023. 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 Poland. 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.
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?
Total consumption of oxycodone (time frame: 24 hours after the end of surgery.). 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 24 Nov 2023.