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Completed

NCT Number: NCT01804114

Continuous Local Anesthetic Infusion Following 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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pain management following hernia repair

Procedure

Continuous infusion of local anesthetic via pain pump following hernia repair

Other names: Placement of pain pump to manage post-operative hernia pain

Placebo for pain management following hernia repair

Procedure

Continuous infusion of placebo via pain pump following hernia repair

Other names: Placement of placebo pain pump

Primary outcomes

  1. Post-Operative Pain

    Time frame: 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 outcomes

  1. Number of Days With Post-Operative Narcotic Analgesic Use

    Time frame: Up to 3 weeks post surgery

    Patients given a diary to record all narcotics taken post-op for pain control.

Other outcomes

  1. Satisfaction With PostOperative Pain Management

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Collaborators

  • Kimberly-Clark Corporation

Registry information

Official study title

Continuous Preperitoneal Infusion of Local Anesthetic Via Pain Pump for Laparoscopic Ventral Hernia Repair

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 5, 2013
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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