A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

NCT ID: NCT03004222

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-11-30

Brief Summary

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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

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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.

Conditions

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Laparoscopic Appendectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Bupivacaine

Intervention Type DRUG

20 ml of 0.5% 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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Interventions

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Bupivacaine

20 ml of 0.5% Bupivacaine

Intervention Type DRUG

Placebos

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Metro Health, Michigan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karlin Sevensma, DO

Role: PRINCIPAL_INVESTIGATOR

Metro Health Hospital

Locations

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Metro Health Hospital

Wyoming, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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Appendectomy Study

Identifier Type: -

Identifier Source: org_study_id

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