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Completed

NCT Number: NCT03004222

A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

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.

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Key information

Conditions

Laparoscopic Appendectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

20 ml of 0.5% Bupivacaine

Placebos

Drug

Primary outcomes

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

    Time frame: 1, 2, 4 hours

Secondary outcomes

  1. Time to Discharge

    Time frame: 12 hours

  2. Pain Level Scores at 1, 2, 4, and 12 hours postoperatively

    Time frame: 12 hours

Sponsors and collaborators

Lead sponsor

Metro Health, Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 28, 2016
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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