Trial Outcomes & Findings for Exparel Interscalene vs Indwelling Catheter (NCT NCT03827213)
NCT ID: NCT03827213
Last Updated: 2023-03-07
Results Overview
Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.
TERMINATED
PHASE2
23 participants
24 Hours post-surgery
2023-03-07
Participant Flow
Participant milestones
| Measure |
Single Shot Interscalene Nerve Block
This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
|
Indwelling Interscalene Catheter
This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump was set at a rate of 4 mL/hr.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Shot Interscalene Nerve Block
n=11 Participants
This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
|
Indwelling Interscalene Catheter
n=12 Participants
This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump was set at a rate of 4 mL/hr.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=23 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=11 Participants
|
4 Participants
n=12 Participants
|
7 Participants
n=23 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=11 Participants
|
8 Participants
n=12 Participants
|
16 Participants
n=23 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=11 Participants
|
7 Participants
n=12 Participants
|
12 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=11 Participants
|
5 Participants
n=12 Participants
|
11 Participants
n=23 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
12 participants
n=12 Participants
|
23 participants
n=23 Participants
|
PRIMARY outcome
Timeframe: 24 Hours post-surgeryPopulation: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Duration of Surgery (Approximately 3 hours)Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 hour post-surgeryPopulation: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During time in PACU (up to 5 hours)Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 hours post-surgeryPopulation: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At Discharge (up to 3 days)Population: Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.
Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.
Outcome measures
Outcome data not reported
Adverse Events
Single Shot Interscalene Nerve Block
Indwelling Interscalene Catheter
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Shot Interscalene Nerve Block
n=11 participants at risk
This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
|
Indwelling Interscalene Catheter
n=12 participants at risk
This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump was set at a rate of 4 mL/hr.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Postoperative Respiratory Complications
|
0.00%
0/11 • Up to 72 hours
|
16.7%
2/12 • Number of events 2 • Up to 72 hours
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • Up to 72 hours
|
0.00%
0/12 • Up to 72 hours
|
|
Nervous system disorders
Dizziness
|
9.1%
1/11 • Number of events 1 • Up to 72 hours
|
0.00%
0/12 • Up to 72 hours
|
|
Cardiac disorders
Angina
|
9.1%
1/11 • Number of events 1 • Up to 72 hours
|
0.00%
0/12 • Up to 72 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place