| Primary | Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year |
- The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.
- 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
| Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure. | Posted | | Median | Inter-Quartile Range | score on a scale | | At 1 year | | | | ID | Title | Description |
|---|
| OG000 | Preoperative PECS Blocks |
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
| | OG001 | Placebo PECS Blocks |
- A sham block (normal saline) will be placed preoperatively
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number.
- Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist.
|
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000(0 to 1)
- OG0010(0 to 0.8)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | Kruskal-Wallis | | 0.68 | | | | | | | | | | | | | | Superiority | | |
|
| Primary | Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year |
- The participant is asked to rate their pain by circling the one number that best describes their pain on the average.
- 0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
| Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure. | Posted | | Median | Inter-Quartile Range | score on a scale | | At 1 year | | | | ID | Title | Description |
|---|
| OG000 | Preoperative PECS Blocks |
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
| | OG001 | Placebo PECS Blocks | |
|
| Primary | Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year |
- The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.
- 0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.
- The scores for each subsection will be averaged.
| Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure. | Posted | | Median | Inter-Quartile Range | score on a scale | | At 1 year | | | | ID | Title | Description |
|---|
| OG000 | Preoperative PECS Blocks |
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
|
|
| Secondary | Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure |
- The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
- The higher the score the better quality of life.
- Scores are standardized to a mean of 50 with a range of -0.809-70.71.
| Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure. | Posted | | Median | Inter-Quartile Range | score on a scale | | At baseline and 1 year post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Preoperative PECS Blocks |
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
|
|
| Secondary | Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure |
- The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
- The higher the score the better quality of life.
- Scores are standardized to a mean of 50 with a range of -1.465-77.09.
| Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure. | Posted | | Median | Inter-Quartile Range | score on a scale | | At baseline and 1 year post-surgery | | | | ID | Title | Description |
|---|
| OG000 | Preoperative PECS Blocks |
- PECS I & II block will be administered preoperatively
- For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL)
- To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
- Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist
|
|