Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Colorectal Cancer Clinical Trial

— PPaM  

Official title:

Precision Pain Management for Major Abdominal Surgery in Colorectal Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03455751
• Other study ID #: 17-1540
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2018
• Est. completion date: January 9, 2019

Study information

• Verified date: March 2019
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 9, 2019
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Colorectal Cancer
• Colorectal Neoplasms
• Crohn Disease
• Diverticular Disease
• Diverticulum
• Ulcerative Colitis

Intervention

Genetic:
• PGx-guided post-operative pain management
Post-operative pain management as indicated by pharmacogenomic testing results.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative opioid use	Post-operative opioid use through visual analog scale guided administration of narcotic equivalent	Post-op day 1
Primary	Overall Benefit of Analgesia Score (OBAS)		Post-op day 1
Secondary	Length of stay		30 days
Secondary	Readmission rate		30 days
Secondary	Functional status	Assessed through Duke Activity Status Index (DASI)	4 weeks and 3 months