Pain, Postoperative; Anesthesia, RegionalNCT04406012
Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients
A study testing paravertebral block in people with Pain, Postoperative; Anesthesia, Regional, run by Eskisehir Osmangazi University.
Trial summary
The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative; Anesthesia, Regional
- What is being tested?
- paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2016to 1 Jul 2016
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
ASA I, II, III patients aged 18-65 who consented to undergo unilateral percutaneous nephrolithotomy were eligible for the study. 53 patients were eligible and assesed.Informed consent was signed by all patients. Patients under 18 years of age, pregnant, with known hypersensitivity to local anesthetics, bleeding diathesis, depression and / or anxiety disorder, obesity (BMI> 35kg / m2), history of pneumothorax, phrenic nerve paralysis, severe aortic stenosis were excluded. Also who did not want to participate the study.
About this study
Official title: Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study
The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.
Read the detailed description
Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS> 4 received additional analgesics.
- Being tested
- paravertebral block
- Keywords
- Pain management, Analgesia, paravertebral block, nephrolithotomy
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
paravertebral block group
| Study group | Role | What they receive |
|---|---|---|
| block group | Active comparator | Paravertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist. Receives: Procedure: paravertebral block |
| Control group | No intervention | Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score >4, tramadol 1 mg kg-1 was administered intravenously. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient VAS scores
0=no pain, 10=incredible pain
Measured: 24 hours
Secondary outcomes (1)
Patient Satisfaction scores
0=not satisfied, 5=very good satisfied
Measured: at the end of the 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start16 Feb 2016
- Primary completion16 Jun 2016
- Study completion1 Jul 2016
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 Pain, Postoperative; Anesthesia, RegionalStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paravertebral block group and Control group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Kırıkkale University
- Responsible party
- Principal investigator, Ferda YAMAN, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406012
- Sponsor's protocol ID
- Eskisehir University
- Other IDs
- Kırıkkale University
- Status last verified
- Sep 2020
- First submitted
- 23 May 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: when the article published
Publications
Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.
PubMed 32993528
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound Guided Paravertebral Block in Percutaneous Nephrolithotomy Patients: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04406012
- Acronym / sponsor ID
- Eskisehir University
- Keywords
- Pain management, Analgesia, paravertebral block, nephrolithotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- Kırıkkale University
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 16 Jun 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 28 May 2020 (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.
The aim of this study is to investigate the analgesic effects of thoracal paravertebral block in the patients undergoing percutaneous nephrolitotomy. Paravertebral block was applied to the study group. Conventional analgesia methods were applied to the control group.
Detailed description
Randomization was divided into two groups by using closed envelope method. Postoperative pain scores at rest at 1, 2, 4, 6, 8, 10, 12, and 24 hours with VAS (0 = no pain, very severe pain = 10) using Visual Analogue Scale was made. VAS at rest and movement (coughing and taking a deep Breath) were evaluated. Patients with VAS> 4 received additional analgesics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Paravertebral block group and Control group
| Arm | Type | Receives |
|---|---|---|
| block group | Active comparator | Procedure: paravertebral blockParavertebral group at Thoracic 9-10 vertebrae level with an in-plane technique advanced ultrasound guided 10 ml bupivacaine hydrochloride (Marcaine 0.5%, Astra Zeneca) in 20 ml volume was enjected in the paravertebral area with real-time visualisation It was observed that the local anesthetic drug spread on the pleura and the pleura was pushed. All blocks were performed by the same experienced anaesthesiologist. |
| Control group | No intervention | –Conventional analgesia methods were applied to the control group. Control group was relieved by dexketoprofen 50mg intravenously. If the patient was not relieved with dexketoprofen and VAS score >4, tramadol 1 mg kg-1 was administered intravenously. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| paravertebral blockparavertebral block group | Procedure or surgery | block group |
Primary outcome
Patient VAS scores
Time frame: 24 hours
0=no pain, 10=incredible pain
1 secondary outcome
Patient Satisfaction scores
Time frame: at the end of the 24 hours
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 29 Sep 2020.
- Derived from this study: PubMed 32993528Yaman F, Tuglu D. Analgesic efficacy of ultrasound guided paravertebral block in percutaneous nephrolithotomy patients: a randomized controlled clinical study. BMC Anesthesiol. 2020 Sep 29;20(1):250. doi: 10.1186/s12871-020-01169-6.
- Individual participant dataSharing planned: No. when the article published
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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.
Questions about this trial
What is this clinical trial studying?
A study testing paravertebral block in people with Pain, Postoperative; Anesthesia, Regional, run by Eskisehir Osmangazi University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Patient VAS scores (time frame: 24 hours). 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 NCT04406012, 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 29 Sep 2020.