Trial Outcomes & Findings for Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair (NCT NCT00485433)

Results Overview

The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

98 participants

Primary outcome timeframe

0 to 72 hours

Results posted on

2021-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivacaine HCl 105mg Bupivacaine HCl given during hernia repair	SKY0402 Low Dose SKY0402 low dose given during hernia repair	SKY0402 Middle Dose SKY0402 middle dose given during hernia repair	SKY0402 High Dose SKY0402 high dose given during hernia repair
Overall Study STARTED	24	25	24	25
Overall Study COMPLETED	24	25	24	25
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-ranging Study for Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine HCl 105mg n=24 Participants Bupivacaine HCl given during hernia repair	SKY0402 Low Dose n=25 Participants SKY0402 low dose given during hernia repair	SKY0402 Middle Dose n=24 Participants SKY0402 middle dose given during hernia repair	SKY0402 High Dose n=25 Participants SKY0402 high dose given during hernia repair	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=99 Participants	19 Participants n=107 Participants	18 Participants n=206 Participants	21 Participants n=7 Participants	79 Participants n=31 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants	6 Participants n=107 Participants	6 Participants n=206 Participants	4 Participants n=7 Participants	19 Participants n=31 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 16.9 • n=99 Participants	51.2 years STANDARD_DEVIATION 17.3 • n=107 Participants	54 years STANDARD_DEVIATION 15.1 • n=206 Participants	52.1 years STANDARD_DEVIATION 15.6 • n=7 Participants	51.1 years STANDARD_DEVIATION 16.2 • n=31 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants
Sex: Female, Male Male	24 Participants n=99 Participants	25 Participants n=107 Participants	24 Participants n=206 Participants	25 Participants n=7 Participants	98 Participants n=31 Participants
Region of Enrollment United States	24 participants n=99 Participants	25 participants n=107 Participants	24 participants n=206 Participants	25 participants n=7 Participants	98 participants n=31 Participants

PRIMARY outcome

Timeframe: 0 to 72 hours

The subject's pain intensity was to be assessed with activity (NRS-A), after the subject had moved himself from a supine position in bed to a sitting up position at the edge of the bed. The subject was to respond to the following question: "On a scale of 0 to 10, where 0=no pain and 10=worst possible pain, how much pain did you have while sitting up?"

Outcome measures

Outcome measures
Measure	Bupivacaine HCl 105mg n=24 Participants A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery	SKY0402 Low Dose n=25 Participants A single dose of SKY0402 105mg diluted to a 42-mL injection volume administered via local infiltration during surgery	SKY0402 Middle Dose n=24 Participants A single dose of SKY0402 180mg diluted to a 42-mL injection volume administered via local infiltration during surgery	SKY0402 High Dose n=25 Participants A single dose of SKY0402 345 mg diluted to a 42-mL injection volume administered via local infiltration during surgery
Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) With Activity (NRS-A) Pain Intensity Scores From 0 Through 72 Hours	298.1 Units on a scale*hours Standard Deviation 136.6	286.9 Units on a scale*hours Standard Deviation 146.4	274.6 Units on a scale*hours Standard Deviation 115.4	274.4 Units on a scale*hours Standard Deviation 253.4

SECONDARY outcome

Timeframe: Up to 30 days

Outcome measures

Outcome data not reported

Adverse Events

Bupivacaine HCl 105mg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

SKY0402 (All Doses)

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupivacaine HCl 105mg n=24 participants at risk Bupivacaine HCl given during hernia repair	SKY0402 (All Doses) n=74 participants at risk SKY0402 given during hernia repair
Injury, poisoning and procedural complications Scar	0.00% 0/24	1.4% 1/74 • Number of events 1

Other adverse events

Other adverse events
Measure	Bupivacaine HCl 105mg n=24 participants at risk Bupivacaine HCl given during hernia repair	SKY0402 (All Doses) n=74 participants at risk SKY0402 given during hernia repair
Gastrointestinal disorders Nausea	20.8% 5/24	8.1% 6/74
Gastrointestinal disorders Constipation	8.3% 2/24	9.5% 7/74
Nervous system disorders Dizziness	8.3% 2/24	8.1% 6/74
Nervous system disorders Hypoaesthesia	8.3% 2/24	1.4% 1/74 • Number of events 1
Cardiac disorders Bradycardia	0.00% 0/24	5.4% 4/74

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