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Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery (PPaM)

NeuroTherapia, Inc. logo

NeuroTherapia, Inc.

Status

Terminated

Conditions

Diverticular Disease
Ulcerative Colitis
Crohn Disease
Colorectal Cancer

Treatments

Genetic: PGx-guided post-operative pain management

Study type

Interventional

Funder types

Other

Identifiers

NCT03455751
17-1540

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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