N/A N=29 Randomized Double-blind Treatment

Continuous Local Anesthetic Infusion Following Hernia Repair

Ventral Hernia

Bottom Line

View on ClinicalTrials.gov: NCT01804114 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Post-Operative Pain — 2.91; 2.1 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pain management following hernia repair (Procedure); Placebo for pain management following hernia repair (Procedure)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Endeavor Health
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Post-Operative Pain	2.91; 2.1	—
SECONDARY Number of Days With Post-Operative Narcotic Analgesic Use	1; 3	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01804114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.