AnalgesiaNCT03110120
Interest of Serratus Plane Block in Postoperative Analgesia for Robot-assisted Surgery
A study testing 0.5% levobupivacaine injectable solution with 10 ml of physiological saline and 0.5% levobupivacaine injectable solution with physiological saline in people with Analgesia and Robotic Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia, Robotic Surgery
- What is being tested?
- 0.5% levobupivacaine injectable solution with 10 ml of physiological saline and 0.5% levobupivacaine injectable solution with physiological saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- May 2015to Jun 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery
Who cannot join
- non robot-assisted surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
The aim of the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.
Read the detailed description
In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.
- Conditions
- Analgesia, Robotic Surgery
- Being tested
- 0.5% levobupivacaine injectable solution with 10 ml of physiological saline, 0.5% levobupivacaine injectable solution with physiological saline
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5% levobupivacaine injectable solution with 10 ml of physiological salineDrug
Also called serratus plane block
Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with 10 ml of physiological salineDrug
Also called local anesthesia
local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
0.5% levobupivacaine injectable solution with physiological salineDrug
Also called local serratus
Serratus plane block realized with 20 ml of injectable solution of physiological saline
0.5% levobupivacaine injectable solution with physiological salineDrug
Also called local control
local infiltration of the wound with 20 ml of injectable solution of physiological saline
| Study group | Role | What they receive |
|---|---|---|
| serratus | Active comparator | Serratus plane block and local control Receives: Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline |
| local | Sham comparator | serratus control and local anesthesia Receives: Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline; Drug: 0.5% levobupivacaine injectable solution with physiological saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
D0 pain intensity
Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)
Measured: 1 day
Secondary outcomes (3)
D1 pain intensity
Self reported pain intensity the days after surgery. Each item is scored 0 - 100 (0 - no pain, 100 - pain as bad as can be)
Measured: 3 days
morphine consumption
Consumption of morphine the day and 4 days after surgery as recorded on the PCA.
Measured: 5 days
persistence of a chronic pain
Phone call 3 month after surgery to evaluate the persistence of pain
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startMay 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Watremez, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110120
- Sponsor's protocol ID
- 2015/07JAN/008
- Status last verified
- Apr 2017
- First submitted
- 8 Mar 2017
- Last updated
- 10 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Serratus Plane Block in Postoperative Analgesia for Patients Undergoing Robot-assisted Mitral Valve Repair, MIDCAB or Partial Lung Resection
- ClinicalTrials.gov ID
- NCT03110120
- Acronym / sponsor ID
- 2015/07JAN/008
- Conditions
- Analgesia, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 12 Apr 2017 (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 the study is to compare the analgesia provided by the serratus plane block with local infiltration of the orifices of the trocars after thoracic robot-assisted surgery.
Detailed description
In our hospital, the current practice to provide post operative analgesia for patients scheduled for robot-assisted mitral repair or oncological thoracic surgery is to dispense local anesthetics at the orifices of the trocars at the end of the surgery and to give a Patient Controlled Analgesia (PCA). Some of these patients are not comfortable and we observe a large percentage of chronic pain. Recently we tried to use the Serratus plane block realised before the beginning of the surgery, and it seemed that patients were more comfortable with a lower consumption of morphine. So we decided to perform a double blind, randomized study in this population of patients to compare the analgesia provided by the serratus plane block realized before the beginning of the surgery and the local infiltration of the wound at the end of the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Compare the efficacy of the serratus plane block with local infiltration after thoracic robot-assisted surgery
| Arm | Type | Receives |
|---|---|---|
| serratus | Active comparator | Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline, Drug: 0.5% levobupivacaine injectable solution with physiological salineSerratus plane block and local control |
| local | Sham comparator | Drug: 0.5% levobupivacaine injectable solution with 10 ml of physiological saline, Drug: 0.5% levobupivacaine injectable solution with physiological salineserratus control and local anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mitral repair, coronary artery revascularization or thoracic surgery scheduled robot-assisted surgery
Key exclusion criteria (1 listed)
- non robot-assisted surgery
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 |
|---|---|---|
| 0.5% levobupivacaine injectable solution with 10 ml of physiological salineAlso: serratus plane blockSerratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline | Drug | serratus |
| 0.5% levobupivacaine injectable solution with 10 ml of physiological salineAlso: local anesthesialocal infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline | Drug | local |
| 0.5% levobupivacaine injectable solution with physiological salineAlso: local serratusSerratus plane block realized with 20 ml of injectable solution of physiological saline | Drug | local |
| 0.5% levobupivacaine injectable solution with physiological salineAlso: local controllocal infiltration of the wound with 20 ml of injectable solution of physiological saline | Drug | serratus |
Primary outcome
D0 pain intensity
Time frame: 1 day
Self reported pain intensity the day of surgery. Each item is scored 0-100 (0 - no pain, 100 - pain as bad as can be)
3 secondary outcomes
D1 pain intensity
Time frame: 3 days
morphine consumption
Time frame: 5 days
persistence of a chronic pain
Time frame: 3 months
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 10 Oct 2017.
- 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.
Christine Watremez, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5% levobupivacaine injectable solution with 10 ml of physiological saline and 0.5% levobupivacaine injectable solution with physiological saline in people with Analgesia and Robotic Surgery, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 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 10 Oct 2017. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
D0 pain intensity (time frame: 1 day). 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 10 Oct 2017.