A Study to Determine the Effectiveness of Utilizing Intra... | NCT03004222

Studies
A Study to Determine the Effectiveness of Utilizing Intraperitoneal Bupivacaine

NCT03004222

Sponsor

Metro Health, Michigan

Status

Completed

Last Update Posted

Jan 18, 2018Actual

Enrollment

137Actual

Phase

Not Applicable

Conditions

Laparoscopic Appendectomy

Interventions

Bupivacaine
Placebos

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Nov 2017Actual

Completion Date

Nov 2017Actual

First Submitted Date

Dec 21, 2016

First Submission Date that Met QC Criteria

Dec 27, 2016

First Posted Date

Dec 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2018

Last Update Posted Date

Jan 18, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

137Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Local anesthetic (Bupivicaine)	Experimental	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
Placebo 20 ml	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine	Drug	20 ml of 0.5% Bupivacaine	Local anesthetic (Bupivicaine)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karlin Sevensma, DO	Metro Health Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Metro Health Hospital		Wyoming	Michigan	49519	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Oct 17, 2023
Reset	Nov 8, 2023
Release	Mar 26, 2024
Reset	Apr 22, 2024

Submission Tracking

Estimated Results First Submitted Date

Oct 17, 2023

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 17, 2023			Nov 8, 2023
Mar 26, 2024

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided