ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,338 studies in Colorectal Neoplasms with a site in United States — 422 open to participants now, 630 under way, 30 of them phase 3. Colorectal Neoplasms · United States.

Enrollment
1,719th of 1,931
10 · median 64
Started
2018
with 95 others
No phase
533 of 2,338
96 open now
Registered
1,241st of 2,338
by date

Among the 2,338 studies in Colorectal Neoplasms with a site in United States, this one is the 1,719th largest by enrollment of the 1,931 interventional ones, is one of 96 that started in 2018, is one of 533 with no phase, and was the 1,241st registered.

By phase

2,338 studies; the count open now beside each. This study's row is marked.

Phase 1551 · 101 open
No phasethis study533 · 96 open
Phase 2509 · 64 open
Observational325 · 69 open
Phase 1/2266 · 68 open
Phase 3117 · 17 open
Phase 419 · 4 open
Phase 2/315 · 2 open
Other kind3 · 1 open

By the year they started

First in 1981; this study’s year is marked. 96 started in 2018.

Size and results

Median enrollment 64 across the 1,931 interventional studies, 221 across the 324 observational. Of the 1,562 that completed or were terminated, 548 (35%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 2,338 studies in Colorectal Neoplasms with a site in United States, or all of them as a file.
02

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.

03

Conditions studied

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

Keywords

  • Pain Management
  • Pharmacogenomics
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
05

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.

06

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

07

Study locations

1 site
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Jan 2019, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 7, 2018
StartActual
Apr 17, 2018
Primary completionActual
Jan 9, 2019
CompletionActual
Jan 9, 2019
Last update
Mar 18, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03455751
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.

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Discussion

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