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Epidural anesthesia for Colonic Pseudo-Obstruction

N/A

Waitlist Available

Research Sponsored by McMaster University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether epidural anesthesia is safe and effective for treating Ogilvie's Syndrome. If successful, it could establish standardized criteria for managing Ogilvie's Syndrome patients with epidural anesthesia.

Eligible Conditions

Colonic Pseudo-Obstruction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Epidural-related morbidity

Follow-up rate

Rate of clinical resolution

+3 more

Secondary outcome measures

Length of stay in hospital

Mean time to clinical resolution

Mean time to radiological resolution

+1 more

Side effects data

From 2017 Phase 4 trial • 46 Patients • NCT02105558

20%

nausea

headache

vomiting

hypotension

100%

80%

60%

40%

20%

Study treatment Arm

Epidural Anesthesia

Combined Spinal and Epidural (CSE) Anesthesia

Trial Design

1Treatment groups

Experimental Treatment

Group I: Epidural anesthesiaExperimental Treatment1 Intervention

The patient will be positioned appropriately and the T11-12 (if not accessible we will accept 1-2 spaces above or below) interspace landmarked using established ultrasound guidance techniques. The patient's back will be prepped and draped in a sterile fashion. An epidural catheter will be inserted into the T11-12 interspace with a midline or paramedian approach using a 17G Tuohy needle. Plain preservative free bupivicaine 0.25% will be the local anesthetic used. After a 2-3 mL test dose to rule out intrathecal catheter positioning, a loading dose of 5-8 mL will be administered over 5-10 minutes to further rule out intravascular positioning of the catheter. Successful epidural placement will be defined by catheter insertion and confirmed by sensory blockade assessed by ice or pin prick testing. When correct positioning is confirmed, a continuous infusion of 3 mL per hour of bupivacaine 0.25% plain solution will begin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epidural anesthesia

2017

Completed Phase 4

~900

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Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor

881 Previous Clinical Trials

2,597,886 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any more participants needed for this trial?

"Affirmatively, the information hosted on clinicaltrials.gov declares that this experiment is recruiting individuals. This investigation was first launched September 1st 2021 and its details were last modified eight days later. 25 participants are being sought from a single site of research."

Answered by AI

To what extent is enrollment increasing for this clinical research?

"Affirmative. According to the information on clinicaltrials.gov, this study is actively recruiting participants and was first posted on September 1st 2021. This research requires 25 volunteers from a single medical location."

Answered by AI

What are the principal goals of this medical experiment?

"The two-year long medical trial is designed to measure the number of people recruited. Secondary objectives include tracking the readmission rate, measuring mean time until radiological resolution, and determining length of hospital stays in response to epidural anesthetic placement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epidural for Ogilvie's Syndrome

2021. "Epidural for Ogilvie's Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04600427.