Trial Outcomes & Findings for Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy (NCT NCT01224145)
NCT ID: NCT01224145
Last Updated: 2020-11-04
Results Overview
Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
COMPLETED
PHASE2
10 participants
0 to 24 hours after surgery
2020-11-04
Participant Flow
Participant milestones
| Measure |
Drug: Bupivacaine Collagen Sponge
4, 5x5 bupivacaine collagen sponges
4, 5x5cm bupivacaine collagen sponges
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assess the Feasibility and Efficacy of the CollaRx® Bupivacaine Implant Laparoscopic Inguinal or Umbilical Herniorrhaphy
Baseline characteristics by cohort
| Measure |
Drug: Bupivacaine Collagen Sponge
n=10 Participants
4, 5x5 bupivacaine collagen sponges
4, 5x5cm bupivacaine collagen sponges
|
|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 9.76 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 24 hours after surgeryDosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=10 Participants
Bupivacaine Collagen Sponge
|
|---|---|
|
Total Use of Opioid Analgesia - Morphine Equivalence (mg)
|
19.3 Morphine Equivalence (mg)
Standard Deviation 15.5
|
PRIMARY outcome
Timeframe: 25-48 hoursDosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=10 Participants
Bupivacaine Collagen Sponge
|
|---|---|
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
|
5.3 Morphine Equivalence (mg)
Standard Deviation 7.3
|
PRIMARY outcome
Timeframe: 49-72 HoursDosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=10 Participants
Bupivacaine Collagen Sponge
|
|---|---|
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
|
2.0 Morphine Equivalence (mg)
Standard Deviation 3.3
|
PRIMARY outcome
Timeframe: 0-48 hours)Dosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=10 Participants
Bupivacaine Collagen Sponge
|
|---|---|
|
Total Use of Opioid Rescue Analgesia Morphine Equivalence (mg)
|
24.6 Morphine Equivalence (mg)
Standard Deviation 21.8
|
PRIMARY outcome
Timeframe: 0-72 hoursDosages of 1 to 2 mg per dose were titrated to patient comfort according to institutional standards and at the investigator's discretion. Once patients could tolerate oral medication, they were offered oral morphine (15 mg tablets) as rescue analgesia if necessary. The dose for patients who weighed less than 75kg was 15mg every 3 to 4 hours as needed for pain control. The dose for patients who weighed 75kg or more was 1-2 tablets (15-30 mg) every 3-4 hours for pain control. Morphine was the preferred rescue medication.
Outcome measures
| Measure |
Bupivacaine Collagen Sponge
n=10 Participants
Bupivacaine Collagen Sponge
|
|---|---|
|
Total Use of Opioid Rescue Analgesia - Morphine Equivalence (mg)
|
26.6 Morphine Equivalence (mg)
Standard Deviation 23.2
|
Adverse Events
Drug: Bupivacaine Collagen Sponge
Serious adverse events
| Measure |
Drug: Bupivacaine Collagen Sponge
n=10 participants at risk
4, 5x5 bupivacaine collagen sponges
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
10.0%
1/10 • Number of events 10
|
Other adverse events
| Measure |
Drug: Bupivacaine Collagen Sponge
n=10 participants at risk
4, 5x5 bupivacaine collagen sponges
|
|---|---|
|
Nervous system disorders
Headache
|
20.0%
2/10 • Number of events 2
|
|
Nervous system disorders
Paresthesia
|
10.0%
1/10 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Itching
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1
|
|
Reproductive system and breast disorders
Scrotal Swelling
|
10.0%
1/10 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Post-op Tremors
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Effusion at Hernia Site
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnea
|
10.0%
1/10 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
20.0%
2/10 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
10.0%
1/10 • Number of events 1
|
Additional Information
Charlene A. Tucker, MS Executive Director, Medical Writing and Document Management
Innocoll
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place