CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Morphine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04752033
NCT04752033Phase 4Completed
CompareCT.gov

Intrathecal Opioids for Pain Control After Colorectal Resection: Determining the Optimal Dose

Mayo Clinic·interventional·Posted Feb 12, 2021·Updated Mar 26, 2024

In Brief

A Phase 4 clinical trial evaluating Morphine and Hydromorphone for Colorectal Surgery and 2 related conditions. Completed, enrolled 80 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Surgery, Pain, Postoperative, Analgesic, Opioid
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedFeb 12, 2021
Enrollment StartMar 10, 2021
Primary CompletionFeb 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.4 years ago

Interventions

Morphinedrug

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.

Hydromorphonedrug

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.