CClinicalTrials.gg
Sign In
TerminatedNCT03455751PPaMUpdated Mar 18, 2019

Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

An interventional study of PGx-guided post-operative pain management in Colorectal Cancer, Diverticular Disease and Crohn Disease, sponsored by The Cleveland Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-03-18.

Sponsored by The Cleveland Clinic · Not applicable, Interventional, and Supportive care

Why this study was terminated
Failed to meet enrollment goals
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer
  • Diverticular Disease
  • Crohn Disease
  • Ulcerative Colitis

Keywords

  • Pain Management
  • Pharmacogenomics
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • No intervention
    Control

    The control arm will receive no intervention and will follow standard of care for post-operative pain management.

  • Experimental
    PGx-guided

    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

  • GeneticPGx-guided post-operative pain management

    Post-operative pain management as indicated by pharmacogenomic testing results.

05

What researchers measure

Primary outcomes

  1. Post-operative opioid use

    Post-operative opioid use through visual analog scale guided administration of narcotic equivalent

    Time frame: Post-op day 1

  2. Overall Benefit of Analgesia Score (OBAS)

    Time frame: Post-op day 1

Secondary outcomes

  1. Length of stay

    Time frame: 30 days

  2. Readmission rate

    Time frame: 30 days

  3. Functional status

    Assessed through Duke Activity Status Index (DASI)

    Time frame: 4 weeks and 3 months

06

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
07

Registry details

Key details

Study ID
NCT03455751
Lead sponsor
The Cleveland Clinic
Responsible party
David Liska (Associate Staff, Colorectal Surgery, The Cleveland Clinic) — Principal investigator
First posted
Mar 7, 2018
Start date
Apr 17, 2018
Primary completion
Jan 9, 2019
Completion
Jan 9, 2019
Last update
Mar 18, 2019

Study contacts

David Liska, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Crohn Disease→

Other studies from this sponsor

The Cleveland Clinic

Start the discussion