Trial Outcomes & Findings for Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction (NCT NCT02161705)

Last Updated: 2020-04-16

Results Overview

To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander breast reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. Post-operative pain, pain medication/narcotic use, and assessment for adverse events (AEs)/serious adverse events (SAEs) will be assessed the Day of surgery through post-operative Day 7. A clinic visit occurs on Day 7 where additional data collected (updated medical history, pain medication/narcotic use, AEs/SAEs, and study questionnaires). Static pain refers to pain when the patient is at rest. Patients report pain on a scale of 0-10 were in 0 represents no pain and 10 the most severe pain they have experienced.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

18 participants

Primary outcome timeframe

Day of Surgery through Day 7

Results posted on

2020-04-16

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine Group Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg). Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block	Saline Group Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner. Saline: Up to 0.8 mL/kg of normal saline administered
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

3 patients in the Saline group did not fill out subjective pain score assessments.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Day of Surgery through Day 7

Population: 1 Patient in the saline group was lost to follow-up

Outcome measures

Outcome measures
Measure	Ropivacaine Group n=9 Participants Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg). Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block	Saline Group n=8 Participants Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner. Saline: Up to 0.8 mL/kg of normal saline administered
Postoperative Static Pain Score	1.5 units on a scale Interval 0.63 to 3.19	1 units on a scale Interval 0.09 to 2.5

SECONDARY outcome

Timeframe: Postoperative Day-30, Day-90 , 2-years, and 4-years (±14 days) after surgery.

Population: The minimum data needed to assess this outcome measure was not collected for any participant and thus could not be analyzed for any of the participants.

To determine if long-term changes in Quality of Life scores \[BREAST-Q scores\] differ between women undergoing mastectomy followed by immediate tissue expander reconstruction randomized either to ropivacaine- (treatment) or saline- (placebo) pre-operatively placed paravertebral blocks. The BREAST-Q score questionnaire items in each scale are arranged in a clinically relevant hierarchy (e.g., Satisfaction with Breasts scale ranges from "How satisfied are you with how you look in a mirror clothed?" to "How satisfied are you with how you look in the mirror unclothed?"). Scores will range from 0-100. Lower scores indicate lower quality of life and vice versa. This data will be collected via validated questionnaires through patient interviews at 1-month, 3-months, 2-years, and 4-years (±14 days) after surgery. Once enrolled in the study, participants will be encouraged to remain in the study for the 4 years following surgery in order to get final pain scores and quality-of-life/heal

Outcome measures

Outcome data not reported

Adverse Events

Ropivacaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline Group

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

Dr. Pathik Aravind

Johns Hopkins University School of Medicine

Phone: 4437879385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ropivacaine Group n=9 Participants Paravertebral block injections of study solution will occur using the landmark-based classic technique with a 22-gauge Tuohy needle to deliver 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg). Ropivacaine: 0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block	Saline Group n=9 Participants Paravertebral block injections of normal saline (up to 0.8 mL/kg) will occur using the landmark-based classic technique with a 22-gauge Tuohy needle. Immediately after completion of the injections, patients will be repositioned supine and general anesthesia induced in the standard manner. Saline: Up to 0.8 mL/kg of normal saline administered	Total n=18 Participants Total of all reporting groups
Moving Pain Score	0 units on a scale n=9 Participants	0 units on a scale n=9 Participants	0 units on a scale n=18 Participants
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=9 Participants	8 Participants n=9 Participants	17 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	1 Participants n=9 Participants	1 Participants n=18 Participants
Age, Continuous	50 Years n=9 Participants	54 Years n=9 Participants	53.5 Years n=18 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	9 Participants n=9 Participants	18 Participants n=18 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	2 Participants n=9 Participants	2 Participants n=18 Participants
Race (NIH/OMB) White	8 Participants n=9 Participants	7 Participants n=9 Participants	15 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=9 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	0 Participants n=9 Participants	1 Participants n=18 Participants
Region of Enrollment United States	9 participants n=9 Participants	9 participants n=9 Participants	18 participants n=18 Participants
Subjective Pain Score	3.38 units on a scale n=9 Participants • 3 patients in the Saline group did not fill out subjective pain score assessments.	3.69 units on a scale n=6 Participants • 3 patients in the Saline group did not fill out subjective pain score assessments.	3.38 units on a scale n=15 Participants • 3 patients in the Saline group did not fill out subjective pain score assessments.
Static Pain Score	0 units on a scale n=9 Participants	0 units on a scale n=9 Participants	0 units on a scale n=18 Participants