Postoperative PainNCT02840526
Thoracic Paravertebral Block in Pain Management After Renal Surgery
A study testing Paravertebral blockade (PVB), Sopodorm and Propofol WZF in people with Postoperative Pain, run by Silesian University of Medicine at 1 site in Poland.
Trial summary
Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative pain management after open renal resection surgery. Design, setting, participants: It was a prospective, randomised, open label study held in a university hospital between 08.2013-12.2014. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Paravertebral blockade (PVB), Sopodorm and Propofol WZF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePoland
- Study dates
- May 2013to Dec 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75
- Scheduled for elective open nephrectomy or NSS
- Gave written consent
- BMI 19-30
- ASA status I-III
Who cannot join
- Presence of chronic pain
- Chronic mental conditions (depression)
- Contraindications for PVB
- Chest or spine deformations
- Infection in planned site of PVB
- Allergies for drugs used in the study
- Cancer invading chest wall
Trial locations and contacts
1 site in 1 country.
Poland1 site
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM Zabrze
Zabrze, Silesian Voivodeship, 41-800
About this study
Official title: Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery
Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative pain management after open renal resection surgery.
Design, setting, participants: It was a prospective, randomised, open label study held in a university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and randomised into two groups - group PVB (n=27) and group GEN (n=31).
Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by general anaesthesia. GEN group received standard general anaesthesia. Both groups were treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS, oxycodone requirement in time points, total oxycodone requirement, and sedation levels throughout the first 48h. The investigators measured opioid related adverse events 24 and 48 h postoperatively and patients satisfaction 48h postoperatively.
Read the detailed description
In PVB group before the induction of general anaesthesia a single shot thoracic paravertebral blockade was performed. ThPVB was performed on Th7-Th10 level, approximately 2,5 - 3 cm lateral from the top of the spinous process with prior ultrasound control of the depth of the transverse process and the pleura. To make the procedure safer the investigators used peripheral nerve stimulation with an isolated 10 cm needle with a start current of 2,5 mA. The needle was inserted until visible muscle activity from intercostal muscles appeared, with a current of 0,5-0,3mA (paravertebral space identification). Next 0,3 ml kg-1 0,5% plain bupivacaine was injected after negative aspiration for air and blood. The efficacy of the blockade was checked after 20 minutes with cold saline.
In both groups, PVB and GEN general anaesthesia was induced with midazolam 0,1 mgkg-1, propofol 2 mgkg-1, cis-atracurium 0,15 mgkg-1 and fentanyl 1,5 µgkg-1. Patients were intubated with a standard single lumen tracheal tube. Anaesthesia was maintained with 1 MAC (Minimal Alveolar Concentration) sevoflurane. For surgical analgesia the investigators used fractional doses of fentanyl 1-3 mg kg-1 if HR (heart rate) or MBP (mean blood pressure) raised above 20% of basal values. Waking up from anaesthesia was in a post-anaesthesia care unit.
Postoperative pain management schedule was identical in both groups. After the surgery, if pain appeared, the patient was given oxycodone i.v. titrated to achieve acceptable analgesia level or until side effects appeared. Every patient received a PCA (Patient controlled analgesia) device with a 1 mgml-1 concentration oxycodone solution with a programmed single bolus dose of 1 mg and a lockout time of 5 minutes. Additionally, patients were given 1g i.v. paracetamol every 6 hours and 100 mg of i.v. ketoprofen every 12 hours.
For 48 h postoperatively, the investigators monitored HR, SBP (systolic blood pressure) , DBP (diastolic blood pressure), sedation level in Ramsay scale, pain intensity at rest in VAS (visual analogue score) scale, oxycodone requirement in pre-selected time points and total oxycodone requirement. The investigators also recorded opioid-related adverse events 24 and 48 h postoperatively in OBAS scale and patients' satisfaction regarding postoperative analgesia 48 h postoperatively in Likert scale.
- Conditions
- Postoperative Pain
- Being tested
- Paravertebral blockade (PVB), Sopodorm, Propofol WZF, Nimbex, Fentanyl WZF
- Keywords
- PVB, PCA, nephrectomy, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paravertebral blockade (PVB)Procedure or surgery
preoperative ThPVB performed unilaterally at Th10 level
SopodormDrug
midazolam 0,1 mgkg-1 intravenously (anesthesia induction)
Propofol WZFDrug
propofol 2 mgkg-1intravenously (anesthesia induction)
NimbexDrug
cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)
Fentanyl WZFDrug
fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)
SevoraneDrug
sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance
IntubationDevice
Intratracheal intubation with a single lumen endotracheal tube
OxynormDrug
1 mgml-1 concentration oxycodone solution intravenously
Paracetamol KabiDrug
1g paracetamol intravenously every 6 hours
KetonalDrug
100 mg ketoprofen intravenously every 12 hours
Bupivacaine WZFDrug
0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)
| Study group | Role | What they receive |
|---|---|---|
| PVB group | Experimental | Thoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi Receives: Procedure: Paravertebral blockade (PVB); Drug: Sopodorm; Drug: Propofol WZF; Drug: Nimbex; Drug: Fentanyl WZF; Drug: Sevorane; Device: Intubation; Drug: Oxynorm; Drug: Paracetamol Kabi; Drug: Ketonal; Drug: Bupivacaine WZF |
| GEN group | Other | Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi Receives: Drug: Sopodorm; Drug: Propofol WZF; Drug: Nimbex; Drug: Fentanyl WZF; Drug: Sevorane; Device: Intubation; Drug: Oxynorm; Drug: Paracetamol Kabi; Drug: Ketonal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in total amount of oxycodone needed in 48 hours after surgery
Measured: 48 hours postoperatively
Secondary outcomes (4)
Difference in prevalence of opioid related adverse events in OBAS scale
Measured: 24 hours, 48 hours after surgery
Difference in pain level in VAS scale
Measured: 48 hours postoperatively
Difference in level of sedation assessed in Ramsay scale
Measured: 48 hours after surgery
Difference in patient satisfaction level assessed in Likert scale
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
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 Postoperative PainStudies 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
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maja Copik, Silesian University of Medicine
- Investigators
- Hanna Misiolek, MD PhD, Study chair, Medical School of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840526
- Sponsor's protocol ID
- SUM-PSK-1
- Status last verified
- Jul 2016
- First submitted
- 22 Nov 2013
- Last updated
- 21 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673.
PubMed 28731925
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thoracic Paravertebral Block in Postoperative Pain Management After Renal Surgery
- ClinicalTrials.gov ID
- NCT02840526
- Acronym / sponsor ID
- SUM-PSK-1
- Conditions
- Postoperative Pain
- Keywords
- PVB, PCA, nephrectomy, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Silesian University of MedicineUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Jul 2016 (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.
Objective: The objective of the study was to assess the usefulness of ThPVB in postoperative pain management after open renal resection surgery.
Design, setting, participants: It was a prospective, randomised, open label study held in a university hospital between 08.2013-12.2014. 58 Patients enrolled in the study were scheduled for elective open renal surgery (open nephrectomy or open nephron-sparing surgery) and randomised into two groups - group PVB (n=27) and group GEN (n=31).
Interventions: PVB group received preoperative ThPVB with 0,5% bupivacaine followed by general anaesthesia. GEN group received standard general anaesthesia. Both groups were treated postoperatively with oxycodone IV PCA (patient controlled analgesia) combined with non-opioid analgesics as rescue drugs. The investigators recorded pain severity in VAS, oxycodone requirement in time points, total oxycodone requirement, and sedation levels throughout the first 48h. The investigators measured opioid related adverse events 24 and 48 h postoperatively and patients satisfaction 48h postoperatively.
Detailed description
In PVB group before the induction of general anaesthesia a single shot thoracic paravertebral blockade was performed. ThPVB was performed on Th7-Th10 level, approximately 2,5 - 3 cm lateral from the top of the spinous process with prior ultrasound control of the depth of the transverse process and the pleura. To make the procedure safer the investigators used peripheral nerve stimulation with an isolated 10 cm needle with a start current of 2,5 mA. The needle was inserted until visible muscle activity from intercostal muscles appeared, with a current of 0,5-0,3mA (paravertebral space identification). Next 0,3 ml kg-1 0,5% plain bupivacaine was injected after negative aspiration for air and blood. The efficacy of the blockade was checked after 20 minutes with cold saline.
In both groups, PVB and GEN general anaesthesia was induced with midazolam 0,1 mgkg-1, propofol 2 mgkg-1, cis-atracurium 0,15 mgkg-1 and fentanyl 1,5 µgkg-1. Patients were intubated with a standard single lumen tracheal tube. Anaesthesia was maintained with 1 MAC (Minimal Alveolar Concentration) sevoflurane. For surgical analgesia the investigators used fractional doses of fentanyl 1-3 mg kg-1 if HR (heart rate) or MBP (mean blood pressure) raised above 20% of basal values. Waking up from anaesthesia was in a post-anaesthesia care unit.
Postoperative pain management schedule was identical in both groups. After the surgery, if pain appeared, the patient was given oxycodone i.v. titrated to achieve acceptable analgesia level or until side effects appeared. Every patient received a PCA (Patient controlled analgesia) device with a 1 mgml-1 concentration oxycodone solution with a programmed single bolus dose of 1 mg and a lockout time of 5 minutes. Additionally, patients were given 1g i.v. paracetamol every 6 hours and 100 mg of i.v. ketoprofen every 12 hours.
For 48 h postoperatively, the investigators monitored HR, SBP (systolic blood pressure) , DBP (diastolic blood pressure), sedation level in Ramsay scale, pain intensity at rest in VAS (visual analogue score) scale, oxycodone requirement in pre-selected time points and total oxycodone requirement. The investigators also recorded opioid-related adverse events 24 and 48 h postoperatively in OBAS scale and patients' satisfaction regarding postoperative analgesia 48 h postoperatively in Likert scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB group | Experimental | Procedure: Paravertebral blockade (PVB), Drug: Sopodorm, Drug: Propofol WZF, Drug: Nimbex, Drug: Fentanyl WZF, Drug: Sevorane, Device: Intubation, Drug: Oxynorm, Drug: Paracetamol Kabi, Drug: Ketonal, Drug: Bupivacaine WZFThoracic paravertebral blockade PVB (preoperatively) Bupivacaine WZF Sopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi |
| GEN group | Other | Drug: Sopodorm, Drug: Propofol WZF, Drug: Nimbex, Drug: Fentanyl WZF, Drug: Sevorane, Device: Intubation, Drug: Oxynorm, Drug: Paracetamol Kabi, Drug: KetonalSopodorm Propofol WZF Fentanyl WZF Nimbex Sevorane Intubation Oxynorm Ketonal Paracetamol Kabi |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75
- Scheduled for elective open nephrectomy or NSS
- Gave written consent
- BMI 19-30
- ASA status I-III
Key exclusion criteria (7 listed)
- Presence of chronic pain
- Chronic mental conditions (depression)
- Contraindications for PVB
- Chest or spine deformations
- Infection in planned site of PVB
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 blockade (PVB)preoperative ThPVB performed unilaterally at Th10 level | Procedure or surgery | PVB group |
| Sopodormmidazolam 0,1 mgkg-1 intravenously (anesthesia induction) | Drug | GEN group, PVB group |
| Propofol WZFpropofol 2 mgkg-1intravenously (anesthesia induction) | Drug | GEN group, PVB group |
| Nimbexcis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction) | Drug | GEN group, PVB group |
| Fentanyl WZFfentanyl 1,5 µgkg-1 intravenously (anesthesia induction) | Drug | GEN group, PVB group |
| Sevoranesevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance | Drug | GEN group, PVB group |
| IntubationIntratracheal intubation with a single lumen endotracheal tube | Device | GEN group, PVB group |
| Oxynorm1 mgml-1 concentration oxycodone solution intravenously | Drug | GEN group, PVB group |
| Paracetamol Kabi1g paracetamol intravenously every 6 hours | Drug | GEN group, PVB group |
| Ketonal100 mg ketoprofen intravenously every 12 hours | Drug | GEN group, PVB group |
| Bupivacaine WZF0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade) | Drug | PVB group |
Primary outcome
Difference in total amount of oxycodone needed in 48 hours after surgery
Time frame: 48 hours postoperatively
4 secondary outcomes
Difference in prevalence of opioid related adverse events in OBAS scale
Time frame: 24 hours, 48 hours after surgery
Difference in pain level in VAS scale
Time frame: 48 hours postoperatively
Difference in level of sedation assessed in Ramsay scale
Time frame: 48 hours after surgery
Difference in patient satisfaction level assessed in Likert scale
Time frame: 48 hours 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 21 Jul 2016.
- Derived from this study: PubMed 28731925Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673.
- 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.
Hanna Misiolek, MD PhD study chair
Medical School of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paravertebral blockade (PVB), Sopodorm and Propofol WZF in people with Postoperative Pain, run by Silesian University of Medicine at 1 site 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 5 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 21 Jul 2016. 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 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?
Difference in total amount of oxycodone needed in 48 hours after surgery (time frame: 48 hours postoperatively). 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 NCT02840526, 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 21 Jul 2016.