Trial Outcomes & Findings for Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy (NCT NCT02104414)
NCT ID: NCT02104414
Last Updated: 2018-12-04
Results Overview
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
11 participants
Primary outcome timeframe
up to 4 days
Results posted on
2018-12-04
Participant Flow
Participant milestones
| Measure |
Exparel
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
30mL Normal Saline
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
2
|
|
Overall Study
COMPLETED
|
5
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Baseline characteristics by cohort
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 14.61 • n=93 Participants
|
40.75 years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
51.5 years
STANDARD_DEVIATION 9.19 • n=27 Participants
|
44.54 years
STANDARD_DEVIATION 10.36 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: up to 4 daysThe primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Outcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Post Operative Pain Control
Day 2
|
3 score on a scale
Interval 0.0 to 10.0
|
4.5 score on a scale
Interval 0.0 to 10.0
|
4 score on a scale
Interval 0.0 to 10.0
|
|
Post Operative Pain Control
Day 3
|
2.25 score on a scale
Interval 0.0 to 10.0
|
5.0 score on a scale
Interval 0.0 to 10.0
|
3 score on a scale
Interval 0.0 to 10.0
|
|
Post Operative Pain Control
Hour 1
|
0 score on a scale
Interval 0.0 to 10.0
|
1.33 score on a scale
Interval 0.0 to 10.0
|
7 score on a scale
Interval 0.0 to 10.0
|
|
Post Operative Pain Control
Hour 2
|
0 score on a scale
Interval 0.0 to 10.0
|
1.0 score on a scale
Interval 0.0 to 10.0
|
2.5 score on a scale
Interval 0.0 to 10.0
|
|
Post Operative Pain Control
Day 1
|
5.75 score on a scale
Interval 0.0 to 10.0
|
6.5 score on a scale
Interval 0.0 to 10.0
|
5.5 score on a scale
Interval 0.0 to 10.0
|
|
Post Operative Pain Control
Day 4
|
2.67 score on a scale
Interval 0.0 to 10.0
|
3.0 score on a scale
Interval 0.0 to 10.0
|
2 score on a scale
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: up to 4 daysNumber of postoperative opioid consumption - oxycodone tablets (5mg each)
Outcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Number of Oxycodone Tablets Taken
Hour 1
|
0 tablets
Standard Deviation 0
|
0 tablets
Standard Deviation 0
|
0 tablets
Standard Deviation 0
|
|
Number of Oxycodone Tablets Taken
Hour 2
|
0 tablets
Standard Deviation 0
|
0 tablets
Standard Deviation 0
|
0 tablets
Standard Deviation 0
|
|
Number of Oxycodone Tablets Taken
Day 1
|
2.2 tablets
Standard Deviation 2.28
|
2.67 tablets
Standard Deviation 1.53
|
1.5 tablets
Standard Deviation 0.71
|
|
Number of Oxycodone Tablets Taken
Day 2
|
2 tablets
Standard Deviation 1.58
|
1.67 tablets
Standard Deviation 0.58
|
2.5 tablets
Standard Deviation 0.71
|
|
Number of Oxycodone Tablets Taken
Day 3
|
1.4 tablets
Standard Deviation 1.52
|
1.5 tablets
Standard Deviation 0.78
|
2.5 tablets
Standard Deviation 0.71
|
|
Number of Oxycodone Tablets Taken
Day 4
|
2 tablets
Standard Deviation 1.63
|
1 tablets
Standard Deviation 0
|
1.5 tablets
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: 1 hour and 2 hours post opOutcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Postoperative Opioid Consumption - Hydromorphone I.V
Hour 1
|
0.35 mg
Standard Deviation 0.47
|
0 mg
Standard Deviation 0
|
0.8 mg
Standard Deviation 0.42
|
|
Postoperative Opioid Consumption - Hydromorphone I.V
Hour 2
|
0.5 mg
Standard Deviation 0.6
|
0 mg
Standard Deviation 0
|
0.6 mg
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: up to 4 daysNumber of participants with postoperative nausea and vomiting episodes
Outcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Number of Participants With Postoperative Nausea and Vomiting
Hour 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Postoperative Nausea and Vomiting
Hour 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Postoperative Nausea and Vomiting
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Postoperative Nausea and Vomiting
Day 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Postoperative Nausea and Vomiting
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Postoperative Nausea and Vomiting
Day 4
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 daysNumber of participants with pain during postoperative bowel movements
Outcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Number of Participants With Pain During Bowel Movements
Day 1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Pain During Bowel Movements
Day 2
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Pain During Bowel Movements
Day 3
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Pain During Bowel Movements
Day 4
|
5 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 4 daysOutcome measures
| Measure |
Exparel
n=5 Participants
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
|
Bupivacaine HCl With Epinephrine
n=4 Participants
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
|
Normal Saline
n=2 Participants
30mL Normal Saline
|
|---|---|---|---|
|
Number of Participants With Urinary Retention
Day 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinary Retention
Day 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinary Retention
Day 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Urinary Retention
Day 4
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Exparel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine HCl With Epinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place