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Clinical Trials/NCT03004222
NCT03004222
Completed
Not Applicable

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

Metro Health, Michigan1 site in 1 country137 target enrollmentJuly 2015

Overview

Phase
Not Applicable
Intervention
Bupivacaine
Conditions
Laparoscopic Appendectomy
Sponsor
Metro Health, Michigan
Enrollment
137
Locations
1
Primary Endpoint
Total narcotic use following surgery until the time of discharge from the hospital.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2015
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Metro Health, Michigan
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Local anesthetic (Bupivicaine)

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

Intervention: Bupivacaine

Placebo 20 ml

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

Intervention: Placebos

Outcomes

Primary Outcomes

Total narcotic use following surgery until the time of discharge from the hospital.

Time Frame: 1, 2, 4 hours

Secondary Outcomes

  • Time to Discharge(12 hours)
  • Pain Level Scores at 1, 2, 4, and 12 hours postoperatively(12 hours)

Study Sites (1)

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