A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

Not Applicable

Completed

• Conditions: Laparoscopic Appendectomy
• Interventions: Drug: Placebos; Drug: Bupivacaine

• Registration Number: NCT03004222
• Lead Sponsor: Metro Health, Michigan

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-27
• Study First Posted: 2016-12-28
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

• Patients 18 years of age and older
• Laparoscopic appendectomy at Metro Health Hospital

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 20 ml	Placebos	75 subjects will be treated with normal saline/placebo to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred
Local anesthetic (Bupivicaine)	Bupivacaine	The experimental arm intervention is 75 subjects will receive the study agent (20 mL of 0.5% bupivacaine) to be sprayed at the cecum after the appendix has been removed and all planned irrigation and aspiration has occurred

Primary Outcome Measures

Name	Time	Method
Total narcotic use following surgery until the time of discharge from the hospital.	1, 2, 4 hours

Secondary Outcome Measures

Name	Time	Method
Time to Discharge	12 hours
Pain Level Scores at 1, 2, 4, and 12 hours postoperatively	12 hours

Trial Locations

Locations (1)

Metro Health Hospital; 🇺🇸 Wyoming, Michigan, United States