Continuous Local Anesthetic Infusion Following Hernia Repair
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2012 |
| End Date: | October 2015 |
Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair
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.
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.
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.
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.
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