Breast CancerNCT03713255
Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial
A study testing PVB group and MTP block group in people with Breast Cancer and Acute Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Acute Pain, Anesthesia
- What is being tested?
- PVB group and MTP block group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2020to 31 Dec 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English or French Speaking
- Scheduled for major breast surgery
- ASA physical status classification I-III
- BMI <30kg/m2
Who cannot join
- Prior ipsilateral breast surgery
- Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
- Contraindications to regional anesthesia
- Patient refusal of regional technique
- Chronic pain disorder
- Chronic opioid use
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Ioana Costache, MD
About this study
Official title: Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial
This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.
Read the detailed description
Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.
- Conditions
- Breast Cancer, Acute Pain, Anesthesia
- Being tested
- PVB group, MTP block group, Control Group
- Keywords
- Regional Anesthesia, Paravertebral Block, Breast Cancer Surgery, MTP block
- Medical subject headings
- Breast Neoplasms, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVB groupProcedure or surgery
Patients in this group will receive preoperative ultrasound-guided thoracic paravertebral block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
MTP block groupProcedure or surgery
Patients in this group will receive preoperative ultrasound-guided mid-point transverse process to pleura block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Control GroupProcedure or surgery
Patients in this group will receive preoperative ultrasound-guided sham block with subcutaneous local anesthetic injection using lidocaine 1%, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
| Study group | Role | What they receive |
|---|---|---|
| PVB group | Active comparator | paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL Receives: Procedure: PVB group |
| MTP block group | Experimental | MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL Receives: Procedure: MTP block group |
| control group | Sham comparator | local anesthetic infiltration subcutaneous 1% lidocaine Receives: Procedure: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia during the first 24 hours.
Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.
Measured: 48 hours
Secondary outcomes (1)
Post-operative quality of recovery during the first 24 hours.
Measured by the Quality of recovery (QoR-15 scale).
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Jan 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research 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
- Model description
- Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ioana Costache, MD, Principal investigator, Ottawa Hospital, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713255
- Sponsor's protocol ID
- 20180259-01H
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2018
- Last updated
- 3 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03713255
- Acronym / sponsor ID
- 20180259-01H
- Conditions
- Breast Cancer, Acute Pain, Anesthesia
- Keywords
- Regional Anesthesia, Paravertebral Block, Breast Cancer Surgery, MTP block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 Oct 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.
This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.
Detailed description
Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| PVB group | Active comparator | Procedure: PVB groupparavertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL |
| MTP block group | Experimental | Procedure: MTP block groupMTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL |
| control group | Sham comparator | Procedure: Control Grouplocal anesthetic infiltration subcutaneous 1% lidocaine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English or French Speaking
- Scheduled for major breast surgery
- ASA physical status classification I-III
- BMI <30kg/m2
Key exclusion criteria (7 listed)
- Prior ipsilateral breast surgery
- Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
- Contraindications to regional anesthesia
- Patient refusal of regional technique
- Chronic pain disorder
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 |
|---|---|---|
| PVB groupPatients in this group will receive preoperative ultrasound-guided thoracic paravertebral block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain). | Procedure or surgery | PVB group |
| MTP block groupPatients in this group will receive preoperative ultrasound-guided mid-point transverse process to pleura block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain). | Procedure or surgery | MTP block group |
| Control GroupPatients in this group will receive preoperative ultrasound-guided sham block with subcutaneous local anesthetic injection using lidocaine 1%, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain). | Procedure or surgery | control group |
Primary outcome
Postoperative analgesia during the first 24 hours.
Time frame: 48 hours
Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.
1 secondary outcome
Post-operative quality of recovery during the first 24 hours.
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ioana Costache, MD principal investigator
Ottawa Hospital, Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVB group and MTP block group in people with Breast Cancer and Acute Pain, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 7 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 3 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioana Costache, MD ((613) 737-8187, icostache@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative analgesia during the first 24 hours. (time frame: 48 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 3 Oct 2022.