Pain, PostoperativeNCT03454191
Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
A study testing Erector spinae plane block and No injection in people with Pain, Postoperative, run by Eric Albrecht at 1 site in Switzerland.
Trial summary
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Erector spinae plane block and No injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2018to 1 Oct 2023
- 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
- Patients scheduled for thoracoscopy
- physical status I-III
Who cannot join
- allergy to local anaesthetics
- other contraindications to peripheral nerve blocks
- patients suffering from chronic pain condition
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne, Canton of Vaud, 1011
About this study
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.
- Conditions
- Pain, Postoperative
- Being tested
- Erector spinae plane block, No injection
- 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 blockProcedure or surgery
Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia
No injectionProcedure or surgery
No injection
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Experimental | Not described Receives: Procedure: Erector spinae plane block |
| Placebo | Placebo comparator | Not described Receives: Procedure: No injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
IV morphine consumption
mg
Measured: 24 postoperative hours
Secondary outcomes (5)
IV morphine consumption
mg
Measured: 2 postoperative hours
IV morphine consumption
mg
Measured: 48 postoperative hours
Pain scores
Visual analog scale, 0-10
Measured: 2, 24, 24 postoperative hours
Chronic pain scores
Visual analog scale, 0-10
Measured: 3 and 6 postoperative months
Forced vital capacity
L
Measured: 24 and 48 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start1 Feb 2018
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Why it stopped: Recruitment stopped due to lack of research assistant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric Albrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eric Albrecht, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454191
- Sponsor's protocol ID
- CER 2017-01772
- Status last verified
- Aug 2024
- First submitted
- 27 Feb 2018
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
- ClinicalTrials.gov ID
- NCT03454191
- Acronym / sponsor ID
- CER 2017-01772
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment stopped due to lack of research assistant
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eric AlbrechtUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 5 Mar 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.
The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Experimental | Procedure: Erector spinae plane block |
| Placebo | Placebo comparator | Procedure: No injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for thoracoscopy
- physical status I-III
Key exclusion criteria (3 listed)
- allergy to local anaesthetics
- other contraindications to peripheral nerve blocks
- patients suffering from chronic pain condition
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 blockInjection of local anaesthetics below the erector spinae muscle after induction of anaesthesia | Procedure or surgery | Erector spinae plane block |
| No injectionNo injection | Procedure or surgery | Placebo |
Primary outcome
IV morphine consumption
Time frame: 24 postoperative hours
mg
5 secondary outcomes
IV morphine consumption
Time frame: 2 postoperative hours
IV morphine consumption
Time frame: 48 postoperative hours
Pain scores
Time frame: 2, 24, 24 postoperative hours
Chronic pain scores
Time frame: 3 and 6 postoperative months
Forced vital capacity
Time frame: 24 and 48 postoperative hours
Results and safety
The study was stopped early (reason given: Recruitment stopped due to lack of research assistant). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block and No injection in people with Pain, Postoperative, run by Eric Albrecht at 1 site in Switzerland.
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 3 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: stopped early, as of the sponsor's last update on 22 Aug 2024. 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 Switzerland. 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 was stopped early (reason given: Recruitment stopped due to lack of research assistant). Results are not available in the source record.
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?
IV morphine consumption (time frame: 24 postoperative hours). 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 Aug 2024.