Lumbar Spinal StenosisNCT04403360
Erector Spinae Plane Block After Lumbar Spinal Stenosis Surgery
A study testing ESPB and Local infiltration by the surgeon in people with Lumbar Spinal Stenosis and Erector Spinae Plane Block, run by Clinique Saint Pierre Ottignies at 1 site in Belgium.
Trial summary
Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Erector Spinae Plane Block
- What is being tested?
- ESPB and Local infiltration by the surgeon
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 1 Apr 2021
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any lumbar spinae surgery on 2 or more lumbar levels
Who cannot join
- Contraindication to NSAID
- Allergy to any local anesthetics
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Clinique Saint Pierre
Ottignies, Brabant Wallon, 1340
Georges SAMOURI, MD, 003210437260, georges.samouri@cspo.be
Nicolas PARISI, MD, 003210437608, nicolas.parisi@cspo.be
About this study
Official title: Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial
Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.
- Conditions
- Lumbar Spinal Stenosis, Erector Spinae Plane Block
- Being tested
- ESPB, Local infiltration by the surgeon
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPBProcedure or surgery
Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
Local infiltration by the surgeonProcedure or surgery
Local infiltration of anesthetics at surgical site after skin incision
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae plane Block (ESPB) group | Experimental | The ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery. Receives: Procedure: ESPB |
| Local anesthesia infiltration by the surgeon | Active comparator | The surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight) Receives: Procedure: Local infiltration by the surgeon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24 h Piritramide consumption
Total consumption of Piritramide consumption after surgery
Measured: 24 hours
Secondary outcomes (1)
Quebec back pain disability scale (QBPDS)
A questionnaire developed to measure the level of functional disability for patients with low back pain
Measured: At 2 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Apr 2021 (estimated)
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 Lumbar Spinal StenosisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Pierre Ottignies
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georges Samouri, Clinique Saint Pierre Ottignies
- Investigators
- Georges SAMOURI, MD, Principal investigator, Clinique Saint Pierre Ottignies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403360
- Sponsor's protocol ID
- B707201837276
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be presented in future manuscripts.
Publications
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Erector Spinae Plane Block on the Postoperative Pain After Lumbar Spinal Stenosis Surgery: Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04403360
- Acronym / sponsor ID
- B707201837276
- Conditions
- Lumbar Spinal Stenosis, Erector Spinae Plane Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Clinique Saint Pierre OttigniesUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 27 May 2020 (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.
Lumbar spinae stenosis surgery is a frequent intervention resulting in important postoperative pain. Management of this postoperative pain is thus important. Different pain management therapies exist. The erector spinae plane (ESP) block was described in 2016. It involves the injection of local anesthetics into the interfascial plane, deep to erector spinae muscle, allowing the blockade of the dorsal and ventral rami of the thoracic spinal nerves. It was initially proposed for analgesia of costal fractures, pulmonary lobectomy and thoracic vertebrae. The ESP block (ESPB) could probably be extended to a large number of surgical procedures. ESPB has so far not been investigated in lumbar spinae stenosis surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae plane Block (ESPB) group | Experimental | Procedure: ESPBThe ultrasound-guided ESPB was realized at T12 level (levo bupivacaine 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight)after the induction of anesthesia but before the start of the surgery. |
| Local anesthesia infiltration by the surgeon | Active comparator | Procedure: Local infiltration by the surgeonThe surgeon infiltrates the surgical site after skin incision with local anesthetics (Levo Bupivacaïne 0.25% + epinephrine 1:200.000 4mg.kg-1 body weight) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any lumbar spinae surgery on 2 or more lumbar levels
Key exclusion criteria (2 listed)
- Contraindication to NSAID
- Allergy to any local anesthetics
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 |
|---|---|---|
| ESPBUltrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery | Procedure or surgery | Erector Spinae plane Block (ESPB) group |
| Local infiltration by the surgeonLocal infiltration of anesthetics at surgical site after skin incision | Procedure or surgery | Local anesthesia infiltration by the surgeon |
Primary outcome
Total 24 h Piritramide consumption
Time frame: 24 hours
Total consumption of Piritramide consumption after surgery
1 secondary outcome
Quebec back pain disability scale (QBPDS)
Time frame: At 2 months]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Results publication: PubMed 27501016Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
- Individual participant dataSharing planned: No. All data will be presented in future manuscripts.
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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.
Georges SAMOURI, MD principal investigator
Clinique Saint Pierre Ottignies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPB and Local infiltration by the surgeon in people with Lumbar Spinal Stenosis and Erector Spinae Plane Block, run by Clinique Saint Pierre Ottignies 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 2 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 27 May 2020. 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. 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 Georges SAMOURI, MD (003210437260, georges.samouri@cspo.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24 h Piritramide consumption (time frame: 24 hours). 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 NCT04403360, 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 27 May 2020.