Continuous Local Anesthetic Infusion Following Hernia Repair
- Conditions
- Ventral Hernia
- Interventions
- Procedure: Pain management following hernia repairProcedure: Placebo for pain management following hernia repair
- Registration Number
- NCT01804114
- Lead Sponsor
- NorthShore University HealthSystem
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
>18 years
- ASA I,II,III
- Scheduled for Laparoscopic Ventral Hernia Repair
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Local anesthetic continuous infusion Pain management following hernia repair Pain management following hernia repair Placebo continuous infusion Placebo for pain management following hernia repair Placebo pain management following hernia repair
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
NorthShore University HealthSystem
🇺🇸Evanston, Illinois, United States