Erector Spinae Plane BlockNCT03887260
Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/Nephron Sparing Surgery(NSS) Performed Via Lumbotomy
A study testing Morphine PCA pump, ESP block and Fentanyl in people with Erector Spinae Plane Block, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Erector Spinae Plane Block
- What is being tested?
- Morphine PCA pump, ESP block and Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2019to 1 Mar 2020
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw
- Pts consented for the study prior to surgery
- ASA 1-3
Who cannot join
- Pts without consent for trial
- Pts ASA 4-5
- Coagulation abnormalities
- Allergy to local anesthetics
- Skin lesions in the place of needle insertion
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Warsaw Clinical University Center
Warsaw, 02-005
Anna Roziewska, 48606932992, anna.roziewska@gmail.com
About this study
Official title: Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy
42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.
- Conditions
- Erector Spinae Plane Block
- Being tested
- Morphine PCA pump, ESP block, Fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine PCA pumpDrug
Morphine given postoperatively.
ESP blockProcedure or surgery
Also called ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000
Regional anaesthesia technique performed under ultrasound guidance before surgery
FentanylDrug
Also called Fentanyl administration during surgery
Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).
| Study group | Role | What they receive |
|---|---|---|
| GA group | Active comparator | Patients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively. Receives: Drug: Morphine PCA pump; Drug: Fentanyl |
| ESP group | Experimental | Patients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously. Receives: Drug: Morphine PCA pump; Procedure: ESP block; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Morphine Requirements
Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.
Measured: 24 hours post surgery
Secondary outcomes (2)
Intraoperative Fentanyl Requirements
Fentanyl consumption in both groups will be recorded ( ug of fentanyl given intraoperatively divided by patients weight in kg and minutes of surgery)
Measured: Time of surgery.
Postoperative Nausea and Vomiting (PONV) PONV PONV
Postoperative nausea and vomiting will be recorded if occurred
Measured: 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Mar 2019
- Primary completion20 Jul 2019 (estimated)
- Study completion1 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erector Spinae Plane BlockStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Warsaw Clinical University Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887260
- Sponsor's protocol ID
- ESPblockLumbotomy
- Status last verified
- Jan 2019
- First submitted
- 11 Mar 2019
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness of Erector Spinae Plane Block in Peri-operative Analgesia for Nephrectomy/NSS Performed Via Lumbotomy
- ClinicalTrials.gov ID
- NCT03887260
- Acronym / sponsor ID
- ESPblockLumbotomy
- Conditions
- Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Warsaw Clinical University Center
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 20 Jul 2019 (estimated)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 22 Mar 2019 (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.
42 patients age of 20 to 85, (ASA) physical status I-III undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anesthesiology in Warsaw will be enrolled in the study. Patients will be randomised into 2 groups - patients from the first group will undergo General Anesthesia (GA) with intravenous analgesia peri-operatively, patients from the second group will receive GA plus the Erector Spinae Plane Block (ESP block) unilaterally performed under ultrasound guidance with catheter left on the side of surgery. Ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the Th7 spinous process. Three muscles will be identified superficial to the hyperechogenic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 18-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip gets in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. . Patients in this group will be anesthetized with 20ml 0,25% bupivacaine + Adrenaline 1:200 000 via interfascial catheter. ESP block will be performed at the level of Th7-8 after proper positioning he patient in the sitting position before GA then standard technique of catheter application will be applied. After the surgery the elastomeric pump will be attached to the catheter with 0,125% bupivacaine with Adrenaline 1:200 000. Anaesthesia will be standardised In the both groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GA group | Active comparator | Drug: Morphine PCA pump, Drug: FentanylPatients will receive general anaesthesia for nephrectomy/NSS procedures via lumbotomy. Analgesia will be provided by titration of fentanyl during surgery. An intravenous patient controlled morphine pump will be used postoperatively. |
| ESP group | Experimental | Drug: Morphine PCA pump, Procedure: ESP block, Drug: FentanylPatients will receive general anaesthesia with ESP block for nephrectomy/NSS procedures via lumbotomy. Catheter will be inserted in the erector spinae plane on the side of surgery. Postoperatively patients will get continuous infusion of 0,125% Bupivacaine+Adrenaline to the catheter for 24h and PCA morphine pump intravenously. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pts undergoing nephrectomy/NSS procedures via lumbotomy in 1st Department of Anaesthesiology in Warsaw
- Pts consented for the study prior to surgery
- ASA 1-3
Key exclusion criteria (5 listed)
- Pts without consent for trial
- Pts ASA 4-5
- Coagulation abnormalities
- Allergy to local anesthetics
- Skin lesions in the place of needle insertion
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 |
|---|---|---|
| Morphine PCA pumpMorphine given postoperatively. | Drug | ESP group, GA group |
| ESP blockAlso: ESP block performed with 0,25% Marcaine+Adrenaline 1:200 000Regional anaesthesia technique performed under ultrasound guidance before surgery | Procedure or surgery | ESP group |
| FentanylAlso: Fentanyl administration during surgeryFentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes). | Drug | ESP group, GA group |
Primary outcome
Postoperative Morphine Requirements
Time frame: 24 hours post surgery
Patient Controlled Analgesia (PCA) morphine consumption in both groups will be recorded.
2 secondary outcomes
Intraoperative Fentanyl Requirements
Time frame: Time of surgery.
Postoperative Nausea and Vomiting (PONV) PONV PONV
Time frame: 24 hours post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine PCA pump, ESP block and Fentanyl in people with Erector Spinae Plane Block, run by Medical University of Warsaw 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Roziewska (48 606932992, anna.roziewska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Morphine Requirements (time frame: 24 hours post 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 22 Mar 2019.