NCT03004222

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
137

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 28, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2.3 years

First QC Date

December 21, 2016

Last Update Submit

January 16, 2018

Conditions

Laparoscopic Appendectomy

Outcome Measures

Primary Outcomes (1)

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

    1, 2, 4 hours

Secondary Outcomes (2)

  • Time to Discharge

    12 hours

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

    12 hours

Study Arms (2)

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

BupivacaineDRUG

20 ml of 0.5% Bupivacaine

Local anesthetic (Bupivicaine)
PlacebosDRUG
Placebo 20 ml

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients 18 years of age and older
  • Laparoscopic appendectomy at Metro Health Hospital

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Karlin Sevensma, DO

    Metro Health Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

December 28, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)