A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

Study Overview
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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.

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

Conditions
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Laparoscopic Appendectomy

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Placebos


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Local anesthetic (Bupivicaine)<br>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 | Drug: Bupivacaine<br>* 20 ml of 0.5% Bupivacaine<br>|
| Placebo Comparator: Placebo 20 ml<br>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 | Drug: Placebos<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total narcotic use following surgery until the time of discharge from the hospital. |  | 1, 2, 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Discharge |  | 12 hours | 
| Pain Level Scores at 1, 2, 4, and 12 hours postoperatively |  | 12 hours |