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A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

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ClinicalTrials.gov Identifier: NCT03004222
Recruitment Status : Completed
First Posted : December 28, 2016
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Laparoscopic Appendectomy Drug: Bupivacaine Drug: Placebos Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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?
Study Start Date : July 2015
Actual Primary Completion Date : November 2017
Actual Study Completion Date : November 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Bupivacaine
20 ml of 0.5% Bupivacaine

Placebo Comparator: 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
Drug: Placebos



Primary Outcome Measures :
  1. Total narcotic use following surgery until the time of discharge from the hospital. [ Time Frame: 1, 2, 4 hours ]

Secondary Outcome Measures :
  1. Time to Discharge [ Time Frame: 12 hours ]
  2. Pain Level Scores at 1, 2, 4, and 12 hours postoperatively [ Time Frame: 12 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03004222


Locations
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United States, Michigan
Metro Health Hospital
Wyoming, Michigan, United States, 49519
Sponsors and Collaborators
Metro Health, Michigan
Investigators
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Principal Investigator: Karlin Sevensma, DO Metro Health Hospital

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Responsible Party: Metro Health, Michigan
ClinicalTrials.gov Identifier: NCT03004222     History of Changes
Other Study ID Numbers: Appendectomy Study
First Posted: December 28, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents