Postoperative PainNCT04751552
Erector Spinae Block for Thoracoscopic Surgery
A study testing Erector Spinae Plane Block (for postoperative pain relief) in people with Postoperative Pain and Thoracic Neoplasms, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Thoracic Neoplasms
- What is being tested?
- Erector Spinae Plane Block (for postoperative pain relief)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Oct 2020to 2 Sep 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 thoracoscopic pulmonary sleeve resection or lobectomy
- Age 18 years or older
- American Society of Anesthesiologists (ASA) health status class I-III
- Informed consent
Who cannot join
- Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
- Contraindication for NSAIDs
- Chronic opioid use
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.
This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.
Read the detailed description
Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.
Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).
Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.
- Conditions
- Postoperative Pain, Thoracic Neoplasms
- Being tested
- Erector Spinae Plane Block (for postoperative pain relief)
- Keywords
- Thoracoscopy, Pain, Regional anaesthesia
- Medical subject headings
- Pain, Postoperative, Thoracic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane Block (for postoperative pain relief)Procedure or surgery
A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.
| Study group | Role | What they receive |
|---|---|---|
| Levobupivacaine group | Active comparator | Patients receive an ESPB with the local anaesthetic levobupivacaine Receives: Procedure: Erector Spinae Plane Block (for postoperative pain relief) |
| Placebo group | Placebo comparator | Patients receive an ESPB with 0,9% saline Receives: Procedure: Erector Spinae Plane Block (for postoperative pain relief) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
Pain level 2 hours after surgery
Measured: 2 hours postoperatively
Pain intensity (NRS) 4 hours after surgery.
Pain level 4 hours after surgery
Measured: 4 hours postoperatively
Pain intensity (NRS) 8 hours after surgery.
Pain level 8 hours after surgery
Measured: 8 hours postoperatively
Pain intensity (NRS) 12 hours after surgery.
Pain level twelve hours after surgery
Measured: 12 hours postoperatively
Secondary outcomes (6)
Pain intensity (NRS) at 8.00 o'clock on the first postoperative day
Pain level at 8.00 o'clock on the first postoperative day
Measured: At 8 o'clock AM on the first postoperative day
Pain intensity (NRS) at 20.00 o'clock on the first postoperative day
Pain level at 20.00 o'clock on the first postoperative day
Measured: At 8 o'clock PM on the first postoperative day
Opioid consumption
Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device
Measured: First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
length of stay in recovery ward (minutes)
length of stay in recovery ward (minutes) after surgery
Measured: First 48 hours after surgery
Patient satisfaction of pain therapy
Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied)
Measured: Measurement in the morning of the second postoperative day
Presence of side effects
Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))
Measured: First 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start21 Oct 2020
- Primary completion1 Sep 2023
- Study completion2 Sep 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled double blind trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Timmerman, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751552
- Sponsor's protocol ID
- L20.047
- Status last verified
- Sep 2023
- First submitted
- 14 Oct 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant participant data underlying the final results and conclusions of the study.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04751552
- Acronym / sponsor ID
- L20.047
- Conditions
- Postoperative Pain, Thoracic Neoplasms
- Keywords
- Thoracoscopy, Pain, Regional anaesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 12 Feb 2021 (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.
This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.
Detailed description
Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.
Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).
Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled double blind trial
| Arm | Type | Receives |
|---|---|---|
| Levobupivacaine group | Active comparator | Procedure: Erector Spinae Plane Block (for postoperative pain relief)Patients receive an ESPB with the local anaesthetic levobupivacaine |
| Placebo group | Placebo comparator | Procedure: Erector Spinae Plane Block (for postoperative pain relief)Patients receive an ESPB with 0,9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy
- Age 18 years or older
Key exclusion criteria (4 listed)
- Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
- Contraindication for NSAIDs
- Chronic opioid use
- Pregnancy
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 Block (for postoperative pain relief)A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5. | Procedure or surgery | Levobupivacaine group, Placebo group |
Primary outcome
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
Time frame: 2 hours postoperatively
Pain level 2 hours after surgery
Pain intensity (NRS) 4 hours after surgery.
Time frame: 4 hours postoperatively
Pain level 4 hours after surgery
Pain intensity (NRS) 8 hours after surgery.
Time frame: 8 hours postoperatively
Pain level 8 hours after surgery
Pain intensity (NRS) 12 hours after surgery.
Time frame: 12 hours postoperatively
Pain level twelve hours after surgery
6 secondary outcomes
Pain intensity (NRS) at 8.00 o'clock on the first postoperative day
Time frame: At 8 o'clock AM on the first postoperative day
Pain intensity (NRS) at 20.00 o'clock on the first postoperative day
Time frame: At 8 o'clock PM on the first postoperative day
Opioid consumption
Time frame: First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
length of stay in recovery ward (minutes)
Time frame: First 48 hours after surgery
Patient satisfaction of pain therapy
Time frame: Measurement in the morning of the second postoperative day
Presence of side effects
Time frame: First 48 hours
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 13 Sep 2023.
- Individual participant dataSharing planned: Yes. Relevant participant data underlying the final results and conclusions of the study.
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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 (for postoperative pain relief) in people with Postoperative Pain and Thoracic Neoplasms, run by St. Antonius Hospital at 1 site in Netherlands.
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 4 inclusion and 4 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 13 Sep 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 Netherlands. 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?
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery. (time frame: 2 hours postoperatively). The study lists 4 primary outcomes in all. 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 13 Sep 2023.