A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

Laparoscopic Appendectomy Clinical Trial

Official title:

A Randomized Double Blinded Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine: Does it Reduce Post-operative Opioid Use Following Laparoscopic Appendectomy?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004222
• Other study ID #: Appendectomy Study
• Status: Completed
• Phase: N/A
• First received: December 21, 2016
• Last updated: January 16, 2018
• Start date: July 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2018
• Source: Metro Health, Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to determine if spraying a local anesthetic to the cecum after a laparoscopic appendectomy decreases the amount of narcotics (pain medicine) needed after surgery and reduces the time to discharge from the hospital.

Description:

The purpose of this study is to determine the effectiveness of using intraperitoneal anesthetic during appendectomy. Subjects will be randomized to receive either 20 mL 0.5% bupivicaine or 20 mL of normal saline (placebo) instilled in the right lower quadrant at the cecum after appendix has been removed. Narcotic consumption will be tracked postoperatively. Hypothesis is that instilling local anesthetic at the cecum during a laparoscopic appendectomy will decrease the amount of narcotic a patient uses postoperatively. Secondarily, this study will attempt to determine if there is a decrease in length of stay for the subjects randomized to the anesthetic infiltration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients 18 years of age and older

• Laparoscopic appendectomy at Metro Health Hospital

Exclusion Criteria:

• Adults unable to consent Non-English speaking patients

• Suspected or known malignant disease

• Patients with known allergies to the local anesthetic

• Utilizes opioid pain medicine for a chronic condition

• Elective laparoscopic appendectomy

• Known allergy or contraindication to ketorolac

Related Conditions & MeSH terms

• Laparoscopic Appendectomy

Intervention

Drug:
• Bupivacaine
20 ml of 0.5% Bupivacaine
• Placebos

Locations

Country	Name	City	State
United States	Metro Health Hospital	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Metro Health, Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total narcotic use following surgery until the time of discharge from the hospital.		1, 2, 4 hours
Secondary	Time to Discharge		12 hours
Secondary	Pain Level Scores at 1, 2, 4, and 12 hours postoperatively		12 hours