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| Name | Class |
|---|---|
| Ministere de la Sante et des Services Sociaux | OTHER |
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The pectoral block is a recently developed regional anesthetic technique that can be used for the treatment of postoperative pain after breast surgery. Injection of local anesthetic between the major and the minor pectoral muscles is defined as the pectoral (PEC) 1 block. This block has not been well characterized in terms of its blocking effects on motor and sensitive nerves (medial and lateral pectoral nerves and intercostal nerves). This clinical trial is divided into two sections: a volunteer study and a patient study.
For the volunteer study, the aim is to assess the sensory territory affected by injection of local anesthetics through a PEC 1 block and to assess motor function in terms of strength of adduction of the affected limb using a dynamometer.
In a prospective, randomized, controlled and double blind study, the aim is to assess the postoperative pain relieving properties of the PEC 1 block in patients undergoing bilateral breast augmentation surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | PEC 1 block with injection of 0.4 mL/kg of normal saline under echoguidance. |
|
| Treatment group | Active Comparator | PEC 1 block with injection of 0.4 mL/kg of 0.25% bupivacaine with 1/400 000 epinephrine under echoguidance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEC 1 block | Procedure | Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score at rest | Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) | Within the first 10 min after arrival to the postanesthesia care unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score on movement | Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) | Within the first 10 min after arrival to the postanesthesia care unit (PACU) |
| Postoperative pain score at rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHUM | Montreal | Quebec | H2W 1T8 | Canada | ||
| CISSS des Laurentides |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29600482 | Derived | Desroches J, Belliveau M, Bilodeau C, Landry M, Roy M, Beaulieu P. Pectoral nerves I block is associated with a significant motor blockade with no dermatomal sensory changes: a prospective volunteer randomized-controlled double-blind study. Can J Anaesth. 2018 Jul;65(7):806-812. doi: 10.1007/s12630-018-1122-2. Epub 2018 Mar 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 14, 2022 | |
| Reset | Sep 21, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 14, 2022 | Sep 21, 2023 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine with epinephrine | Drug | Treatment group |
|
| Normal saline | Drug | Placebo group |
|
Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo) |
| 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU |
| Incidence of nausea and/or vomiting | Presence or absence of nausea and/or vomiting | 15 min, 30 min, 60 min, 12h and 24 h after time of arrival in the PACU and immediately after discharge from PACU |
| Surgical bleeding | Presence or not of surgical bleeding from wounds, drains eventually leading to surgical exploration | After surgery for 24 hours |
| Hematoma | Presence or absence of hematoma at PEC 1 block injection | After surgery for 24 hours |
| Postoperative well-being | Analgesic intake | At 24 hours after surgery |
| Saint-Jérôme |
| Quebec |
| Canada |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |