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Extensive protocol revisions initiated.
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| Name | Class |
|---|---|
| Duke University | OTHER |
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The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
The pectoralis block, including pecs I and II block, is a novel technique first described in 2011 as an alternative to paravertebral blockade for analgesia following breast surgery. The concept involves injecting local anesthetic near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). This is a prospective, double-blinded, randomized controlled trial in subjects undergoing mastectomy under general anesthesia. The research goal is to determine the efficacy of the pectoralis block compared to placebo in improving quality of recovery following mastectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pectoralis Block with Ropivacaine | Active Comparator | General anesthesia + pectoralis block with ropivacaine injection 30ml of 0.25% (75mg) |
|
| Pectoralis Block with normal saline | Placebo Comparator | General anesthesia + Pectoralis block with 30ml of normal saline injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pectoralis block | Procedure | Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II). |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery-27 score at baseline | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery at baseline | Baseline |
| Quality of Recovery-27 score at post operative day 1 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 1 | Post operative day 1 |
| Quality of Recovery-27 scores at post operative day 7 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 7 | Post operative day 7 |
| Quality of Recovery-27 scores at post operative day 30 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 30 | Post operative day 30 |
| Quality of Recovery-27 scores at post operative day 90 | Quality of Recovery-27 score, a validated tool to assess quality of postoperative recovery, at baseline and post operative day 90 | Post operative day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Numerical Rating Scale-11 (NRS-11) at rest | Comparison of patient reported pain assessment while at rest using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma Shastri, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Participants will be assigned to one of two of the following groups for the duration of the study.
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Participants, care providers, investigators, and observers who record central measurements will be blinded to group allocation.
| Normal saline injection | Drug | Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior |
|
| Ropivacaine Injection | Drug | Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior |
|
| Comparison of Numerical Rating Scale-11 (NRS-11) with movement | Comparison of patient reported pain assessment while with movement using the NRS-11 Scale at arrival in PACU, 15 minutes, 30 minutes, 1 hour and 2 hours after arrival in PACU, and postoperative days 1, 7, 30, and 90. The NRS-11 is a 11 point scale when 0 is no pain and 10 is severe pain. | 90 days |
| Duration of postoperative analgesia | Duration of postoperative analgesia as measured by time in minutes to first intravenous or oral opioid postoperatively. | Up to 24 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |