Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair

Postoperative Pain Clinical Trial

Official title:

Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01530815
• Other study ID #: LapHernia_SBCH
• Status: Recruiting
• Phase: N/A
• First received: February 8, 2012
• Last updated: February 9, 2012
• Start date: August 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2012
• Source: Chang, Steve S., M.D.
• Contact: Steve Chang, MD
• Phone: 805-637-0217
• Email: s1chang[@]sbch.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

Description:

The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study

2. Age 18 or older

3. Patient must agree to complete pain journal postoperatively

4. Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal

Exclusion Criteria:

1. Any surgical procedure occurring besides the study procedure

2. Any allergy or sensitivity to bupivicaine or its derivatives

3. Less than 18 years of age

4. Patient unable to self report in pain journal due to cognitive disabilities

5. Discharged less than 4 hours post-surgery

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia, Ventral
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivicaine Infusion
Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall

Locations

Country	Name	City	State
United States	Santa Barbara Cottage Hospital	Santa Barbara	California

Sponsors (1)

Lead Sponsor	Collaborator
Chang, Steve S., M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	We will measure pain based on pain journal and usage of postoperative pain medication	24 hours	No