Trial Outcomes & Findings for Enhanced Recovery Strategies in Elective Breast Surgery (NCT NCT03187080)
NCT ID: NCT03187080
Last Updated: 2024-08-23
Results Overview
Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
113 participants
Primary outcome timeframe
Postoperative day 1
Results posted on
2024-08-23
Participant Flow
Participants were enrolled from October 2017 to June 2021. Research was put on Divisional Hold in January 2022. May 2024 determination was made to close the study.
Participant milestones
| Measure |
Group 1 Arm A
Breast reduction with Paravertebral block using local anesthetic.
Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline: Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia.
Paravertebral block using local anesthetic: Use of local anesthetic (0.25% bupivacaine) that is \*NOT\* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline: Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline: Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia.
Paravertebral block using local anesthetic: Use of local anesthetic (0.25% bupivacaine) that is \*NOT\* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline: Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia.
|
Group 3 Arm A
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
Enhanced recovery after breast surgery (ERABS) strategies: For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies:
* Standardized written information given preoperatively.
* Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
* Use paravertebral block to augment postoperative pain control.
* Standardized multimodal analgesic regimen
* Antiemetics
* Easily accessible call-in or walk-in postop care/support
The proposed strategies differ from standard of care in the following ways:
* PVB is less commonly used in elective surgery.
* Patients do not eat or drink after midnight.
* There is no standardized preoperative information packet.
* Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
Enhanced recovery after breast surgery (ERABS) strategies: For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies:
* Standardized written information given preoperatively.
* Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
* Use paravertebral block to augment postoperative pain control.
* Standardized multimodal analgesic regimen
* Antiemetics
* Easily accessible call-in or walk-in postop care/support
The proposed strategies differ from standard of care in the following ways:
* PVB is less commonly used in elective surgery.
* Patients do not eat or drink after midnight.
* There is no standardized preoperative information packet.
* Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
65
|
0
|
0
|
0
|
16
|
0
|
32
|
0
|
|
Overall Study
COMPLETED
|
65
|
0
|
0
|
0
|
16
|
0
|
32
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 21.7 • n=65 Participants
|
—
|
—
|
—
|
31.0 years
STANDARD_DEVIATION 17.5 • n=16 Participants
|
—
|
26.6 years
STANDARD_DEVIATION 20.1 • n=32 Participants
|
—
|
34.9 years
STANDARD_DEVIATION 18.5 • n=113 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=65 Participants
|
—
|
—
|
—
|
16 Participants
n=16 Participants
|
—
|
32 Participants
n=32 Participants
|
—
|
113 Participants
n=113 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=65 Participants
|
—
|
—
|
—
|
0 Participants
n=16 Participants
|
—
|
0 Participants
n=32 Participants
|
—
|
0 Participants
n=113 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
65 participants
n=65 Participants
|
—
|
—
|
—
|
16 participants
n=16 Participants
|
—
|
32 participants
n=32 Participants
|
—
|
113 participants
n=113 Participants
|
|
Body Mass Index (BMI)
|
32.6 kg/m^2
STANDARD_DEVIATION 4.7 • n=65 Participants
|
—
|
—
|
—
|
32.8 kg/m^2
STANDARD_DEVIATION 5.4 • n=16 Participants
|
—
|
24.4 kg/m^2
STANDARD_DEVIATION 2.8 • n=32 Participants
|
—
|
30.3 kg/m^2
STANDARD_DEVIATION 5.7 • n=113 Participants
|
PRIMARY outcome
Timeframe: Postoperative day 1Population: Study was terminated early, participants not enrolled in all planned arms.
Our primary outcome of interest is self-reported pain (0-10 visual analog scale) on post-operative day 1 (POD1). Higher scores indicates higher levels of pain.
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Numerical Pain Scores, Rated by Patient on 0-10 Scale
|
5.8 score on a scale
Standard Deviation 2.3
|
—
|
—
|
—
|
5.9 score on a scale
Standard Deviation 1.9
|
—
|
6.7 score on a scale
Standard Deviation 1.8
|
—
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Pain scores in Post Anesthesia Care Unit (PACU) / recovery area. Pain scored from 0-10 where higher scores indicates higher levels of pain.
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Numerical Pain Scores, Rated by Patient on 0-10 Scale
|
4.7 score on a scale
Standard Deviation 2.5
|
—
|
—
|
—
|
5.4 score on a scale
Standard Deviation 3.3
|
—
|
4.5 score on a scale
Standard Deviation 2.3
|
—
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Time spent in recovery after surgery in the PACU and Phase II (the area of recovery that patients transition to between PACU and discharge)
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Time Spent in Each Phase of Care Prior to Discharge
PACU
|
42 minutes
Standard Deviation 38
|
—
|
—
|
—
|
25 minutes
Standard Deviation 17
|
—
|
28 minutes
Standard Deviation 15
|
—
|
|
Time Spent in Each Phase of Care Prior to Discharge
Phase II
|
92 minutes
Standard Deviation 58
|
—
|
—
|
—
|
64 minutes
Standard Deviation 43
|
—
|
99 minutes
Standard Deviation 55
|
—
|
SECONDARY outcome
Timeframe: Day of surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Time between conclusion of surgery and discharge from the surgery center
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Time to Discharge to Home
|
127 minutes
Standard Deviation 78
|
—
|
—
|
—
|
127 minutes
Standard Deviation 67
|
—
|
89 minutes
Standard Deviation 56
|
—
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
Oxycodone
|
0 Participants
|
—
|
—
|
—
|
1 Participants
|
—
|
1 Participants
|
—
|
|
Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
Tylenol
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
—
|
4 Participants
|
—
|
|
Analgesic Requirements Reported as the Number of Participants Who Were Still Taking Medications Post-Operatively Day 7
Ibuprofen
|
2 Participants
|
—
|
—
|
—
|
2 Participants
|
—
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Occurrence of nausea and vomiting after surgery
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Post-operative Nausea and Vomiting (Subjective Report) Measured as the Mean Incidence Reported Post-Operatively Day 7
|
3.2 events per week
Standard Deviation 1.6
|
—
|
—
|
—
|
0.45 events per week
Standard Deviation 1.0
|
—
|
1.0 events per week
Standard Deviation 1.1
|
—
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Use of anti-nausea mediation postoperatively
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Anti-emetic Requirements Measured as Number of Participants Taking Anti-nausea Medication Post-Operatively Day 7
|
0 Participants
|
—
|
—
|
—
|
0 Participants
|
—
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: 1 week after surgeryPopulation: Study was terminated early, participants not enrolled in all planned arms.
Patients' assessment of quality of recovery using validated 'quality of recovery 40' survey. This survey is scored from 1-5 where higher scores indicate better quality of recovery.
Outcome measures
| Measure |
Group 1 Arm A
n=65 Participants
Breast reduction with Paravertebral block using local anesthetic.
|
Group 1 Arm B
Breast reduction with Sham paravertebral block using saline.
|
Group 2 Arm A
Breast augmentation with Paravertebral block using local anesthetic.
|
Group 2 Arm B
Breast augmentation with Sham paravertebral block using saline.
|
Group 3 Arm A
n=16 Participants
Breast reduction with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 3 Arm B
Breast reduction, standard perioperative management.
|
Group 4 Arm A
n=32 Participants
Breast augmentation with Enhanced recovery after breast surgery (ERABS) strategies.
|
Group 4 Arm B
Breast augmentation, standard perioperative management.
|
|---|---|---|---|---|---|---|---|---|
|
Patients' Assessment of Perceived Quality of Recovery Using Modified Quality of Recovery Survey (MQOR-40)
|
3.3 score on a scale
Standard Deviation 1.6
|
—
|
—
|
—
|
2.3 score on a scale
Standard Deviation 2.1
|
—
|
2.3 score on a scale
Standard Deviation 2.0
|
—
|
Adverse Events
Group 1 Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1 Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 Arm A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 Arm B
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Venkat Rao, MD, MBA
University of Wisconsin School of Medicine and Public Health
Phone: (608) 263-1223
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place