Continuous Local Anesthetic Infusion Following Hernia Repair

Ventral Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01804114
• Other study ID #: EH11-297
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2020
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Procedure:
• Pain management following hernia repair
Continuous infusion of local anesthetic via pain pump following hernia repair
• Placebo for pain management following hernia repair
Continuous infusion of placebo via pain pump following hernia repair

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
NorthShore University HealthSystem	Kimberly-Clark Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Satisfaction scores reported twice daily for up to the 7th day postoperatively
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.	Verbal Rating Scale used twice a day, up to 7 days postoperatively
Secondary	Number of Days With Post-Operative Narcotic Analgesic Use	Patients given a diary to record all narcotics taken post-op for pain control.	Up to 3 weeks post surgery