Postoperative PainPhase 4NCT03415555
Postoperative Analgesia After Minithoracotomy
A Phase 4 study testing Erector Spinae Plane blockade, Oxycodone and general anesthesia in people with Postoperative Pain and Mitral Valve Disease, run by Medical University of Lublin at 1 site in Poland.
Trial summary
Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Mitral Valve Disease
- What is being tested?
- Erector Spinae Plane blockade, Oxycodone and general anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 sitePoland
- Study dates
- 7 Feb 2018to 18 Apr 2018
- Phase
- Phase 4
- 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
- Scheduled mitral valve replacement surgery
- obtained consent
Who cannot join
- allergy to oxycodone and local anesthetics
- depression, antidepressant drugs treatment
- epilepsy
- usage of painkiller before surgery
- addiction to alcohol or recreational drugs
- postoperative ventilation or ICU admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement
Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.
Read the detailed description
Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.
Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.
Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. This is standard protocol in our department.
Only patients who are successfully awakened after the procedure may participate in the study.
The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia.
The total consumption of oxycodone will be also monitored.
- Conditions
- Postoperative Pain, Mitral Valve Disease
- Being tested
- Erector Spinae Plane blockade, Oxycodone, general anesthesia, paracetamol
- Keywords
- Erector Spinae Plane blockade, patient control anlagesia, mitral valve replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane blockadeProcedure or surgery
Also called ESP
Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.
OxycodoneDrug
Also called PCA with oxycodone
Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.
general anesthesiaProcedure or surgery
Also called GA
Each patient will generally anesthetized and endotracheal tube will be inserted
paracetamolDrug
Paracetamol will be given i.v. every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| ESP | Experimental | Before the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. Receives: Procedure: Erector Spinae Plane blockade; Drug: Oxycodone; Procedure: general anesthesia; Drug: paracetamol |
| PCA | Experimental | Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm. Receives: Drug: Oxycodone; Procedure: general anesthesia; Drug: paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Patients' self-pain assessment with VAS (visual-analogue scale)
Measured: From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome).
Secondary outcomes (1)
Total consumption of oxycodone
The cumulative consumption of oxycodone during 24 hour from the end of anesthesia.
Measured: From the end of anesthesia till 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start7 Feb 2018
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rzeszow
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
- Investigators
- Mirosław Czuczwar, M.D., PhD, Study chair, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415555
- Sponsor's protocol ID
- KE-0254/26/2018
- Status last verified
- Nov 2023
- First submitted
- 23 Jan 2018
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane (ESP) Blockade in Patients Scheduled for Minimally Invasively Mitral Valve Replacement
- ClinicalTrials.gov ID
- NCT03415555
- Acronym / sponsor ID
- KE-0254/26/2018
- Conditions
- Postoperative Pain, Mitral Valve Disease
- Keywords
- Erector Spinae Plane blockade, patient control anlagesia, mitral valve replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- University of Rzeszow
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 30 Jan 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.
Patients scheduled for minimally invasive mitral valve replacement. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Half of the patients will be randomly allocated to Erector Spinae Plane (ESP) blockade group.
Detailed description
Only patients who are qualified for an elective procedure of mitral valve replacement may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: etomidate, remifentanil, rocuronium, scolina as required. The maintenance: sevoflurane, remifentanil, rocuronium. The emergence: oxygen, sugammadex or neostigmine a required.
Patients will be randomly allocated into one of two groups: PCA or ESP. Among the patients from ESP group will have ESP blockade before the induction of general anesthesia. ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.
Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. This is standard protocol in our department.
Only patients who are successfully awakened after the procedure may participate in the study.
The pain intensity will be assessed with visual-analogue scale (VAS) at 2, 4, 8, 12 and 24 hour after the end of anesthesia.
The total consumption of oxycodone will be also monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| ESP | Experimental | Procedure: Erector Spinae Plane blockade, Drug: Oxycodone, Procedure: general anesthesia, Drug: paracetamolBefore the induction of general anesthesia, Erector Spinae Plane (ESP) blockade will be done. Postoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. |
| PCA | Experimental | Drug: Oxycodone, Procedure: general anesthesia, Drug: paracetamolPostoperative analgesia is provided with intravenous oxycodone. Patient-controlled analgesia pump (PCA) will be used for this purpose. ESP will not be done in this arm. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled mitral valve replacement surgery
- obtained consent
Key exclusion criteria (6 listed)
- allergy to oxycodone and 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 |
|---|---|---|
| Erector Spinae Plane blockadeAlso: ESPBefore the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL. | Procedure or surgery | ESP |
| OxycodoneAlso: PCA with oxycodoneEach patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval. | Drug | ESP, PCA |
| general anesthesiaAlso: GAEach patient will generally anesthetized and endotracheal tube will be inserted | Procedure or surgery | ESP, PCA |
| paracetamolParacetamol will be given i.v. every 6 hours. | Drug | ESP, PCA |
Primary outcome
Pain intensity
Time frame: From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome).
Patients' self-pain assessment with VAS (visual-analogue scale)
1 secondary outcome
Total consumption of oxycodone
Time frame: From the end of anesthesia till 24 hour postoperatively
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 28 Nov 2023.
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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.
Mirosław Czuczwar, M.D., PhD study chair
Medical University of Lublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erector Spinae Plane blockade, Oxycodone and general anesthesia in people with Postoperative Pain and Mitral Valve Disease, run by Medical University of Lublin 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 2 inclusion and 6 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 28 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain intensity (time frame: From the end of anesthesia till 24 hour postoperatively. VAS range from 0 (no pain, good outcome) to 100 in millimeters (the worst pain ever, bad outcome).). 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 28 Nov 2023.