MedTrace Logo

Intrathecal Opioids for Colorectal Resection

NCT04752033 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-26

Study results available
· View outcomes & findings →

Summary

This research study is being done to determine the optimal dose of spinal morphine and hydromorphone in patients undergoing minimally-invasive (i.e., surgery performed through small entry sites and using cameras) colorectal surgery.

Conditions

  • Colorectal Surgery
  • Pain, Postoperative
  • Analgesic, Opioid

Interventions

DRUG

Morphine

Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.

DRUG

Hydromorphone

Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.

Sponsors & Collaborators

Principal Investigators

  • Adam W Amundson, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2023-02-17
Completion
2023-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04752033 on ClinicalTrials.gov