Ventral Hernia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREPain management following hernia repair
Continuous infusion of local anesthetic via pain pump following hernia repair
PROCEDUREPlacebo for pain management following hernia repair
Continuous infusion of placebo via pain pump following hernia repair
Sponsors
Kimberly-Clark Corporation
Endeavor Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\>18 years * ASA I,II,III * Scheduled for Laparoscopic Ventral Hernia Repair
Exclusion criteria
* ASA IV or greater * Needing emergency surgery * Known history of drug abuse * GI, liver, kidney or other condition which, per the surgeon's opinion, could interfere with the absorption, distribution, metabolism or excretion of any drug used during the duration of the study * Patients with a prior allergic reaction or dependency to morphine, demerol, dilaudid, fentanyl, marcaine(bupivicaine), lidocaine, or ropivicaine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | Verbal Rating Scale used twice a day, up to 7 days postoperatively | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Days With Post-Operative Narcotic Analgesic Use | Up to 3 weeks post surgery | Patients given a diary to record all narcotics taken post-op for pain control. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With PostOperative Pain Management | Satisfaction scores reported twice daily for up to the 7th day postoperatively | 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. |
Countries
United States
Participant flow
Pre-assignment details
Two subjects were enrolled and withdrawn prior to assignment of arm/group because their surgeries were converted from laparoscopic to open.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 17 |
| 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 | 12 |
| Total | 29 |
Baseline characteristics
| Characteristic | Placebo Continuous Infusion | Local Anesthetic Continuous Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 4 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 13 Participants | 21 Participants |
| Age, Continuous | 60.9 years STANDARD_DEVIATION 9.1 | 60.1 years STANDARD_DEVIATION 12.2 | 60.4 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 12 participants | 17 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 5 Participants | 6 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 12 |
| serious Total, serious adverse events | 0 / 17 | 0 / 12 |
Outcome results
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.
Time frame: Verbal Rating Scale used twice a day, up to 7 days postoperatively
Population: A verbal rating scale was used to collect self-reported outcomes; higher numbers indicated less pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic Continuous Infusion | Post-Operative Pain | 2.91 score on a scale | Standard Deviation 0.05 |
| Placebo Continuous Infusion | Post-Operative Pain | 2.1 score on a scale | Standard Deviation 0.05 |
Secondary
Number of Days With Post-Operative Narcotic Analgesic Use
Patients given a diary to record all narcotics taken post-op for pain control.
Time frame: Up to 3 weeks post surgery
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Local Anesthetic Continuous Infusion | Number of Days With Post-Operative Narcotic Analgesic Use | 1 Days |
| Placebo Continuous Infusion | Number of Days With Post-Operative Narcotic Analgesic Use | 3 Days |
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.
Time frame: Satisfaction scores reported twice daily for up to the 7th day postoperatively
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Local Anesthetic Continuous Infusion | Satisfaction With PostOperative Pain Management | 8.3 units on a scale | Standard Error 0.4 |
| Placebo Continuous Infusion | Satisfaction With PostOperative Pain Management | 9 units on a scale | Standard Error 0.5 |