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| Name | Class |
|---|---|
| Kimberly-Clark Corporation | INDUSTRY |
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The primary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower incidence of pain than those patients treated with a placebo, saline-filled pain pump.The secondary endpoint of this study will determine if subjects receiving a continuous infusion of local anesthetic following laparoscopic ventral hernia repair, with the pain pump installed as described to treat post surgical pain will have a lower utilization of narcotic analgesic medication than those patients treated with the placebo, saline-filled pain pump.
Patients will be screened to determine study eligibility using inclusion/exclusion criteria. Following the consent process, subjects will be randomly assigned to a treatment arm (anesthetic or placebo group). Baseline data will be collected prior surgical implantation of the pain pump delivery system. Both study and control groups will be able to receive supplemental medication for breakthrough pain as determined by the surgeon. Post-operative data will be collected up to three weeks following surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local anesthetic continuous infusion | Active Comparator | Pain management following hernia repair |
|
| Placebo continuous infusion | Placebo Comparator | Placebo pain management following hernia repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain management following hernia repair | Procedure | Continuous infusion of local anesthetic via pain pump following hernia repair |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post-Operative Pain | Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported. | Verbal Rating Scale used twice a day, up to 7 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Post-Operative Narcotic Analgesic Use | Patients given a diary to record all narcotics taken post-op for pain control. | Up to 3 weeks post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction With PostOperative Pain Management | Subjects report satisfaction with how pain is managed for the first 7 days postoperatively, on a Numerical Rating Scale of 1-10; higher scores indicate less pain and greater satisfaction. Two daily scores were averaged to compute a single value for each day. | Satisfaction scores reported twice daily for up to the 7th day postoperatively |
Inclusion Criteria:
>18 years
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Ujiki, MD | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States |
Two subjects were enrolled and withdrawn prior to assignment of arm/group because their surgeries were converted from laparoscopic to open.
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| ID | Title | Description |
|---|---|---|
| FG000 | Local Anesthetic Continuous Infusion | Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair |
| FG001 | Placebo Continuous Infusion | Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Local Anesthetic Continuous Infusion | Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair |
| BG001 | Placebo Continuous Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-Operative Pain | Patients will self-report pain assessments on questionnaires each of the first seven days post-operatively using the 4 Point Verbal Rating Scale; ranging from 1=Severe Pain, to 4=No Pain, higher scores indicating less pain, or a better outcome. Values for two daily scores were averaged for each participant, the average across 7 days is reported. | A verbal rating scale was used to collect self-reported outcomes; higher numbers indicated less pain. | Posted | Mean | Standard Deviation | score on a scale | Verbal Rating Scale used twice a day, up to 7 days postoperatively |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Local Anesthetic Continuous Infusion | Pain management following hernia repair Pain management following hernia repair: Continuous infusion of local anesthetic via pain pump following hernia repair |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Ujiki, MD | NSUHS | 8475701700 | rpulido@northshore.org |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo for pain management following hernia repair | Procedure | Continuous infusion of placebo via pain pump following hernia repair |
|
|
Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Placebo Continuous Infusion |
Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair |
|
|
| Secondary | Number of Days With Post-Operative Narcotic Analgesic Use | Patients given a diary to record all narcotics taken post-op for pain control. | Subjects recorded days of postoperative narcotics used after discharge (this supplemented pump infusion). Of the total 29 receiving continuous infusion, 13 anesthetic infusion subjects completed the Post Operative Narcotic Analgesic Use Diary, and 8 placebo subjects completed this diary. | Posted | Median | Inter-Quartile Range | Days | Up to 3 weeks post surgery |
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|
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| Other Pre-specified | Satisfaction With PostOperative Pain Management | Subjects report satisfaction with how pain is managed for the first 7 days postoperatively, on a Numerical Rating Scale of 1-10; higher scores indicate less pain and greater satisfaction. Two daily scores were averaged to compute a single value for each day. | Subjects reported satisfaction of postoperative pain management on a range of 1-10; higher scores indicate less pain and greater satisfaction. The outcome is an average of 7 days of self-reported scores. Of the 17 subjects receiving continuous infusion of local anesthetic, 11 completed this questionnaire, and 6 of the 12 placebo subjects completed this questionnaire. | Posted | Mean | Standard Error | units on a scale | Satisfaction scores reported twice daily for up to the 7th day postoperatively |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Placebo Continuous Infusion | Placebo pain management following hernia repair Placebo for pain management following hernia repair: Continuous infusion of placebo via pain pump following hernia repair | 0 | 12 | 0 | 12 |
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