Trial Outcomes & Findings for Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy (NCT NCT00744848)
NCT ID: NCT00744848
Last Updated: 2013-08-06
Results Overview
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
204 participants
Primary outcome timeframe
through 96 hours
Results posted on
2013-08-06
Participant Flow
Participant milestones
| Measure |
Bupivacaine HCl
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
|
SKY0402
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
|---|---|---|
|
Overall Study
STARTED
|
103
|
101
|
|
Overall Study
COMPLETED
|
103
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
Baseline characteristics by cohort
| Measure |
Bupivacaine HCl
n=103 Participants
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
|
SKY0402
n=101 Participants
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
94 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
189 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age Continuous
|
49 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
50.2 years
STANDARD_DEVIATION 11 • n=7 Participants
|
49.6 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
103 participants
n=5 Participants
|
101 participants
n=7 Participants
|
204 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: through 96 hoursPopulation: Note: 204 randomized subjects received study drug and were included in the analyses.
To assess pain intensity at rest (NRS-R), the subject was to assume a resting position that did not exacerbate his or her postoperative pain. The subject was to rest in this position for at least 5 minutes before responding to the following question, "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain are you having right now?"
Outcome measures
| Measure |
Bupivacaine HCl
n=103 Participants
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
|
SKY0402
n=101 Participants
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
|---|---|---|
|
Area Under the Curve (AUC) of the Numeric Rating Scale at Rest (NRS-R) Pain Intensity Scores
|
359 Units on a scale*hours
Standard Deviation 194
|
396 Units on a scale*hours
Standard Deviation 213
|
SECONDARY outcome
Timeframe: through day 30Outcome measures
Outcome data not reported
Adverse Events
Bupivacaine HCl
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
SKY0402
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bupivacaine HCl
n=103 participants at risk
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
|
SKY0402
n=101 participants at risk
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
|---|---|---|
|
General disorders
Chronic Postop Pain
|
0.00%
0/103
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Fecal Impaction
|
0.00%
0/103
|
0.99%
1/101 • Number of events 1
|
|
Gastrointestinal disorders
Bleeding Ulcer
|
0.97%
1/103 • Number of events 1
|
0.00%
0/101
|
Other adverse events
| Measure |
Bupivacaine HCl
n=103 participants at risk
100 mg Bupivacaine HCl (e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402.
|
SKY0402
n=101 participants at risk
Single administration 300 mg SKY0402 in a 40-mL injection volume via local infiltration.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
31.1%
32/103
|
37.6%
38/101
|
|
Gastrointestinal disorders
Constipation
|
11.7%
12/103
|
15.8%
16/101
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
9/103
|
15.8%
16/101
|
|
Gastrointestinal disorders
Flatulence
|
1.9%
2/103
|
5.0%
5/101
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/103
|
5.0%
5/101
|
|
General disorders
Pyrexia
|
0.00%
0/103
|
7.9%
8/101
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
3.9%
4/103
|
5.0%
5/101
|
|
Nervous system disorders
Headache
|
6.8%
7/103
|
3.0%
3/101
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/103
|
5.0%
5/101
|
Additional Information
Executive Medical Director
Pacira Pharmaceuticals, Inc.
Phone: 203-837-6500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place