Breast Cancer Patients Undergoing Mastectomy With Immediate ReconstructionESPNCT05590559
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial
A study testing Morphine and Ultrasound-guided erector spinae plane block in people with Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
The objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction
- What is being tested?
- Morphine and Ultrasound-guided erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2021to 31 Dec 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (18 years of age or older)
- ASA I-III
- Patients scheduled for elective unilateral mastectomy followed by direct reconstruction
- Ability to give written and oral informed consent
Who cannot join
- Patient refusal
- Non-elective surgery
- Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease )
- Allergy to amide-linked local anesthetics
- Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block)
- Severe spinal malformations or history of extensive spine surgery - A history of spinal cord injury
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- Known psychiatric disorder
- Chronic pain patients or patients already using opioids pre-operatively
- Infection of the skin at the site of needle puncture area - Inability to give oral and written informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
NKI-AvL
Amsterdam, North Holland, 1066CX
Sandra Broens, +31205122506, s.broens@nki.nl
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial. A Single-centre Randomized Controlled Non-inferiority Trial With a Parallel Group Design
The objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction.
Read the detailed description
n breast cancer treatment, surgery plays a central role in combination with chemotherapy, radiation and immunotherapy. Surgery may vary from conservative breast sparing interventions to large radical mastectomies with axillary lymph node dissection that require reconstructive (prosthetic) surgery. In many instances, reconstruction is not performed immediately, but immediate reconstruction is possible and offers many advantages to patients.
The Antoni van Leeuwenhoek hospital performs a large proportion (77%) of mastectomies with immediate reconstruction in the Netherlands. The combination of mastectomy with immediate reconstruction in one operation offers an extra challenge with regards to pain control. Post-operative pain is often treated with opioids, which has systemic side effects (nausea and vomiting). Opioids also inhibit cell-mediated immunity, which is a principal defense against cancer. Regional anesthetic techniques are often performed to reduce opioid consumption and enhance postoperative recovery. The current standard for regional anesthesia for breast surgery is the paravertebral block (PVB). This technique has the potential for severe complications such as epidural hematoma, hemo- or pneumothorax. The erector spinae plane block (ESP) was first described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, the ESP block has relatively few contraindications and has therefore been suggested as an alternative to PVB when contra-indications, such as a bleeding diathesis, are present.Multiple studies have shown a decrease in opioid consumption in patients undergoing mastectomy, when ESP was compared to placebo. ESP has also been shown to be non-inferior to PVB for pain relief in patients undergoing thoracotomy. To date, only two studies have compared ESP to PVB for breast surgery, with conflicting results. In this study, we would like to investigate whether ESP can be considered non-inferior to PVB with regards to pain relief and use of opioids.
- Being tested
- Morphine, Ultrasound-guided erector spinae plane block
- Keywords
- Ultrasound-guided erector spinae plane block, paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Opiates
Ultrasound-guided erector spinae plane blockOther
PVB
| Study group | Role | What they receive |
|---|---|---|
| paravertebral block | Active comparator | Not described Receives: Drug: Morphine |
| Ultrasound-guided erector spinae plane block | Experimental | Not described Receives: Other: Ultrasound-guided erector spinae plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room
Measured: 1 day
Difference in the ratio of the means of cumulative opioid dose (administered during admission in the recovery room)
Measured: 1 day
Secondary outcomes (7)
Success rate as defined by satisfactory spread of local anaesthetic agents on ultrasound
Measured: 1 month
Ease of procedure (self-reported by anaesthetist on scale of 1-5)
Measured: 1 month
Total opioid dose administered on day 0 and on day 1 (iv, subcutaneous or oral - converted to morphine equivalent dose (MEQ)
Measured: 1 day after dose administration
Highest pain score on day 0 and 1
Measured: 1 day
Time to readiness for discharge from the recovery room
Measured: 1 day
Complications of block (such as block failure, epidural hematoma, hemo- or pneumothorax and symptoms of toxicity of local anesthetics)
Measured: 1 day
Patient satisfaction on a scale of 0 (extremely unsatisfied) tot 10 (extremely satisfied)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Patients Undergoing Mastectomy With Immediate ReconstructionStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590559
- Sponsor's protocol ID
- N20ESP
- Acronym
- ESP
- Status last verified
- Oct 2022
- First submitted
- 18 Oct 2022
- Last updated
- 21 Oct 2022
- 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 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block in Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction - a Non-inferiority Trial. A Single-centre Randomized Controlled Non-inferiority Trial With a Parallel Group Design
- ClinicalTrials.gov ID
- NCT05590559
- Acronym / sponsor ID
- ESP / N20ESP
- Keywords
- Ultrasound-guided erector spinae plane block, paravertebral block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 21 Oct 2022 (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 objective of this study is to assess the non-inferiority of analgesic efficacy of ESP vs PVB for patients undergoing unilateral mastectomy followed by immediate reconstruction.
Detailed description
n breast cancer treatment, surgery plays a central role in combination with chemotherapy, radiation and immunotherapy. Surgery may vary from conservative breast sparing interventions to large radical mastectomies with axillary lymph node dissection that require reconstructive (prosthetic) surgery. In many instances, reconstruction is not performed immediately, but immediate reconstruction is possible and offers many advantages to patients.
The Antoni van Leeuwenhoek hospital performs a large proportion (77%) of mastectomies with immediate reconstruction in the Netherlands. The combination of mastectomy with immediate reconstruction in one operation offers an extra challenge with regards to pain control. Post-operative pain is often treated with opioids, which has systemic side effects (nausea and vomiting). Opioids also inhibit cell-mediated immunity, which is a principal defense against cancer. Regional anesthetic techniques are often performed to reduce opioid consumption and enhance postoperative recovery. The current standard for regional anesthesia for breast surgery is the paravertebral block (PVB). This technique has the potential for severe complications such as epidural hematoma, hemo- or pneumothorax. The erector spinae plane block (ESP) was first described in 2016 as a novel regional anesthetic technique for acute and chronic thoracic pain. The site of injection is distant from the pleura, major blood vessels, and spinal cord; hence, the ESP block has relatively few contraindications and has therefore been suggested as an alternative to PVB when contra-indications, such as a bleeding diathesis, are present.Multiple studies have shown a decrease in opioid consumption in patients undergoing mastectomy, when ESP was compared to placebo. ESP has also been shown to be non-inferior to PVB for pain relief in patients undergoing thoracotomy. To date, only two studies have compared ESP to PVB for breast surgery, with conflicting results. In this study, we would like to investigate whether ESP can be considered non-inferior to PVB with regards to pain relief and use of opioids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paravertebral block | Active comparator | Drug: Morphine |
| Ultrasound-guided erector spinae plane block | Experimental | Other: Ultrasound-guided erector spinae plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (18 years of age or older)
- ASA I-III
- Patients scheduled for elective unilateral mastectomy followed by direct reconstruction
- Ability to give written and oral informed consent
Key exclusion criteria (9 listed)
- Patient refusal
- Non-elective surgery
- Any contraindication to paravertebral block (including bleeding diathesis, coagulopathy, severe pulmonary disease )
- Allergy to amide-linked local anesthetics
- Cardiac conductivity disorders (e:g: 2nd and 3rd AV-block)
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 |
|---|---|---|
| MorphineOpiates | Drug | paravertebral block |
| Ultrasound-guided erector spinae plane blockPVB | Other | Ultrasound-guided erector spinae plane block |
Primary outcome
Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room
Time frame: 1 day
Difference in the ratio of the means of cumulative opioid dose (administered during admission in the recovery room)
Time frame: 1 day
7 secondary outcomes
Success rate as defined by satisfactory spread of local anaesthetic agents on ultrasound
Time frame: 1 month
Ease of procedure (self-reported by anaesthetist on scale of 1-5)
Time frame: 1 month
Total opioid dose administered on day 0 and on day 1 (iv, subcutaneous or oral - converted to morphine equivalent dose (MEQ)
Time frame: 1 day after dose administration
Highest pain score on day 0 and 1
Time frame: 1 day
Time to readiness for discharge from the recovery room
Time frame: 1 day
Complications of block (such as block failure, epidural hematoma, hemo- or pneumothorax and symptoms of toxicity of local anesthetics)
Time frame: 1 day
Patient satisfaction on a scale of 0 (extremely unsatisfied) tot 10 (extremely satisfied)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
Related trials for Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine and Ultrasound-guided erector spinae plane block in people with Breast Cancer Patients Undergoing Mastectomy With Immediate Reconstruction, run by The Netherlands Cancer Institute 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 9 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 21 Oct 2022. 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. 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 Sandra Broens, PhD (+31(0)205122506, s.broens@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference of highest numerical rating score (NRS - a linear 11 point scale for self-reported pain) during admission in the recovery room (time frame: 1 day). The study lists 2 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 21 Oct 2022.