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This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVB group | Active Comparator | paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL |
|
| MTP block group | Experimental | MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL |
|
| control group | Sham Comparator | local anesthetic infiltration subcutaneous 1% lidocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PVB group | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia during the first 24 hours. | Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative quality of recovery during the first 24 hours. | Measured by the Quality of recovery (QoR-15 scale). | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ioana Costache, MD | Contact | (613) 737-8187 | icostache@toh.ca |
| Name | Affiliation | Role |
|---|---|---|
| Ioana Costache, MD | Ottawa Hospital, Ottawa Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Recruiting | Ottawa | Ontario | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
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Quadruple (participant, care provider, investigator, outcomes assessor)
|
| MTP block group | Procedure | 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 Group | Procedure | 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). |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |