Trial Outcomes & Findings for PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery (NCT NCT03084536)
NCT ID: NCT03084536
Last Updated: 2024-12-24
Results Overview
* 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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
134 participants
Primary outcome timeframe
At 1 year
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
Not Randomized to an Arm
-Participants were removed from the study prior to being randomized into an Arm.
|
|---|---|---|---|
|
Overall Study
STARTED
|
53
|
54
|
27
|
|
Overall Study
COMPLETED
|
53
|
54
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
27
|
Reasons for withdrawal
| Measure |
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
|
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.
|
Not Randomized to an Arm
-Participants were removed from the study prior to being randomized into an Arm.
|
|---|---|---|---|
|
Overall Study
Determined to be ineligible
|
0
|
0
|
16
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
3
|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Withdrawn due to time of surgery being moved up.
|
0
|
0
|
1
|
Baseline Characteristics
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Baseline characteristics by cohort
| Measure |
Preoperative PECS Blocks
n=53 Participants
* 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
|
Placebo PECS Blocks
n=54 Participants
* 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.
|
Not Randomized to an Arm
n=27 Participants
-Participants were removed from the study prior to being randomized into an Arm.
|
Total
n=134 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.91 years
n=5 Participants
|
62.27 years
n=7 Participants
|
65.46 years
n=5 Participants
|
61.36 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
112 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=5 Participants
|
54 participants
n=7 Participants
|
27 participants
n=5 Participants
|
134 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 1 yearPopulation: Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.
* 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.
Outcome measures
| Measure |
Preoperative PECS Blocks
n=29 Participants
* 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
|
Placebo PECS Blocks
n=32 Participants
* 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.
|
|---|---|---|
|
Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
|
0 score on a scale
Interval 0.0 to 1.0
|
0 score on a scale
Interval 0.0 to 0.8
|
PRIMARY outcome
Timeframe: At 1 yearPopulation: Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.
* 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.
Outcome measures
| Measure |
Preoperative PECS Blocks
n=29 Participants
* 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
|
Placebo PECS Blocks
n=32 Participants
* 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.
|
|---|---|---|
|
Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
|
0 score on a scale
Interval 0.0 to 0.2
|
0 score on a scale
Interval 0.0 to 0.2
|
PRIMARY outcome
Timeframe: At 1 yearPopulation: Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.
* 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.
Outcome measures
| Measure |
Preoperative PECS Blocks
n=28 Participants
* 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
|
Placebo PECS Blocks
n=32 Participants
* 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.
|
|---|---|---|
|
Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: At baseline and 1 year post-surgeryPopulation: Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome 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.
Outcome measures
| Measure |
Preoperative PECS Blocks
n=11 Participants
* 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
|
Placebo PECS Blocks
n=15 Participants
* 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.
|
|---|---|---|
|
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
|
-3.1 score on a scale
Interval -18.0 to 1.9
|
-0.8 score on a scale
Interval -10.3 to 7.8
|
SECONDARY outcome
Timeframe: At baseline and 1 year post-surgeryPopulation: Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome 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.
Outcome measures
| Measure |
Preoperative PECS Blocks
n=11 Participants
* 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
|
Placebo PECS Blocks
n=15 Participants
* 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.
|
|---|---|---|
|
Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
|
0 score on a scale
Interval -5.5 to 7.6
|
1.9 score on a scale
Interval -5.8 to 11.3
|
Adverse Events
Preoperative PECS Blocks
Serious events: 0 serious events
Other events: 5 other events
Deaths: 1 deaths
Placebo PECS Blocks
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Not Randomized to an Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preoperative PECS Blocks
n=53 participants at risk
* 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
|
Placebo PECS Blocks
n=54 participants at risk
* 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.
|
Not Randomized to an Arm
-Participants were removed from the study prior to being randomized into an Arm and did not receive any treatment on the study.
|
|---|---|---|---|
|
Vascular disorders
Hematoma
|
3.8%
2/53 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
0.00%
0/54 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
—
0/0 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
|
General disorders
Swelling
|
1.9%
1/53 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
0.00%
0/54 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
—
0/0 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
|
Injury, poisoning and procedural complications
Seroma
|
3.8%
2/53 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
0.00%
0/54 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
—
0/0 • -Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
|
Additional Information
Ryan C. Guffey, M.D.
Washington University School of Medicine
Phone: 314-286-2883
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place