Precision Pain Management for Major Abdominal Surgery in... | NCT03455751

Studies
Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

NCT03455751

Sponsor

The Cleveland Clinic

Status

Terminated

Last Update Posted

Mar 18, 2019Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Colorectal Cancer
Diverticular Disease
Crohn Disease
Ulcerative Colitis

Interventions

PGx-guided post-operative pain management

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failed to meet enrollment goals

Expanded Access Info

Start Date

Apr 17, 2018Actual

Primary Completion Date

Jan 9, 2019Actual

Completion Date

Jan 9, 2019Actual

First Submitted Date

Feb 28, 2018

First Submission Date that Met QC Criteria

Mar 6, 2018

First Posted Date

Mar 7, 2018Actual

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

Mar 14, 2019

Last Update Posted Date

Mar 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 primary objectives of this study are to evaluate the potential for preoperative pharmacogenomics (PGx) testing to positively influence postoperative opioid use through visual analog scale (VAS) guided administration of narcotic equivalent and lower pain scores as measured by OBAS in patients undergoing major abdominal surgery.

Detailed Description

Not provided

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

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	The control arm will receive no intervention and will follow standard of care for post-operative pain management.
PGx-guided	Experimental	The PGx-guided arm will received altered post-operative pain management based on the results of pharmacogenomic testing.	Genetic: PGx-guided post-operative pain management

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PGx-guided post-operative pain management	Genetic	Post-operative pain management as indicated by pharmacogenomic testing results.	PGx-guided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-operative opioid use	Post-operative opioid use through visual analog scale guided administration of narcotic equivalent	Post-op day 1
Overall Benefit of Analgesia Score (OBAS)		Post-op day 1

Secondary Outcomes

Measure	Description	Time Frame
Length of stay		30 days
Readmission rate		30 days
Functional status

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject capable of giving consent
Age 18-80
Scheduled for open colorectal resection at Cleveland Clinic main campus (with preoperative appointment scheduled at least five days before date of surgery)

Exclusion Criteria:

Patient does not speak English
Patient with substance-use disorder (including alcohol)
Patient diagnosed with major depression
Patient currently taking opioids
Previous long-term opioid use (> 3 months)
Previous opioid use with a dose of >100 milligram morphine equivalent (MME)
Patient has pain-related disorder (e.g. fibromyalgia, sympathetic dystrophy, etc.)
Documented allergy to pain medication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Liska, MD	The Cleveland Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic		Cleveland	Ohio	44195	United States

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D000076385	Diverticular Diseases
D003424	Crohn Disease
D003093	Colitis, Ulcerative
D000377	Agnosia

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided