- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600427
Epidural for Ogilvie's Syndrome
Epidural Blockade for Ogilvie's Syndrome: A Prospective Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently, treatment pathways for Ogilvie's Syndrome suggest observation and attempted correction of the potential precipitating factors for 24 to 72 hours following radiologic assessment if the cecum is less than 12cm and abdominal imaging does not demonstrate signs of impending perforation. Should symptoms fail to resolve beyond 72 hours, and the cecum remain under 12cm without worsening clinical status, pharmacologic intervention with neostigmine is indicated. Symptoms resolve in 60% to 90% of patients following administration of single dose of neostigmine, however continued monitoring is required as up to 40% of these patients can experience recurrent colonic dilation. Additionally, neostigmine can be associated with serious adverse events such as bradycardia and bronchospasm. Altogether, there may be potential for further optimization of the pharmacologic management of Ogilvie's Syndrome.
Given the predominant theory that Ogilvie's Syndrome is caused by sympathetic overdrive, the splanchnic sympathetic blockade provided by epidural anesthesia could be of theoretical benefit. In 1988, a small, prospective cohort study evaluated the use of epidural anesthesia in eight patients with Ogilvie's Syndrome. Symptoms were controlled and cecal dilation resolved without recurrence in 62.5% of these patients, and the authors concluded that with further study, the use of epidural anesthesia could be a reasonable alternative to neostigmine. Yet, no subsequent studies were performed.
This proposed single-arm, single-center prospective cohort pilot study will examine the feasibility, safety, and efficacy of epidural anesthesia in patients with Ogilvie's Syndrome refractory to conservative management. Adult patients with a documented diagnosis of Ogilvie's Syndrome admitted as an inpatient to St. Joseph's Healthcare Hamilton (SJHH) who failed conservative management will be included. Following assessment of eligibility and the informed consent process, patients will be evaluated by the acute pain service anesthesiologist. A low-dose bupivacaine (0.25%) infusion will commence following insertion of an epidural catheter at the T11-12 interspace, with a loading dose of 5-10mL followed by a 3mL per hour infusion. Monitoring for resolution of disease will take place iteratively by the general surgery team, and failed symptom resolution will mandate further treatment in the form of colonoscopic decompression or surgical intervention. Patients will be followed throughout their index hospital and stay and up to 30 days following discharge from hospital. Feasibility will be assessed through recruitment rate and rate of successful epidural placement. The rate of epidural anesthesia-related morbidity within 30 days of treatment will serve as the primary safety measure. The primary efficacy measure is clinical and radiologic resolution without recurrence.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Cagla Eskicioglu, MD
- Phone Number: 35921 905-522-1155
- Email: eskicio@mcmaster.ca
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >18 years old
- Admitted to an inpatient ward at SJHH with a documented diagnosis of Ogilvie's Syndrome/Acute Colonic Pseudo-Obstruction
- Failed conservative management for at least 24-48 hours
Exclusion Criteria:
- Hemodynamic instability
- Peritonitis on abdominal examination
- Cecal diameter greater than 12cm or evidence of hollow viscus perforation on abdominal imaging (e.g. bowel wall thickening, mesenteric stranding, hypoenhancement of bowel wall)
- Documented allergic reaction to anesthetic agent
- Bacteremia
- Local soft tissue infection at the puncture site
- Coagulopathy or therapeutic anticoagulation
- Intracranial pathology leading to increased intracranial pressure
- Prior spinal surgery
- Unstable severe respiratory or cardiovascular disease
- Previously managed with epidural anesthesia for Ogilvie's Syndrome
- Inability/unwilling to consent to trial treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epidural anesthesia
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.
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T11-12 epidural blockade with 0.25% bupivacaine continuous infusion.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate
Time Frame: 2 years
|
Larger study will be considered feasible if a recruitment rate of 1 patient per month is achieved.
|
2 years
|
Successful epidural insertion
Time Frame: 2 years
|
A minimum successful epidural insertion rate of 80%.
Successful epidural placement will be defined by catheter insertion and confirmed by sensory blockade assessed by ice or pin prick testing.
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2 years
|
Follow-up rate
Time Frame: 2 years
|
Larger study will be considered feasible if more than 80% of patients recruited have a full 30 days of follow up data.
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2 years
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Epidural-related morbidity
Time Frame: 30 days
|
. Overall morbidity will include the following complications: hypotension, nausea, vomiting, bronchoconstriction, post dural-puncture headache, transient neurological syndrome, neurologic deficit, meningitis, epidural hematoma, epidural abscess, osteomyelitis, and systemic local anesthesia toxicity.
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30 days
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Rate of clinical resolution
Time Frame: 2 years
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Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
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2 years
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Rate of radiological resolution
Time Frame: 2 years
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Radiological resolution will be defined as decreased cecal diameter to less than 9cm
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Readmission rate
Time Frame: 30 days
|
Rate of readmission to hospital following intervention and subsequent discharge will be reported as secondary safety outcomes.
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30 days
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Length of stay in hospital
Time Frame: 30 days
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Length of stay in hospital following placement of epidural anesthesia
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30 days
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Mean time to clinical resolution
Time Frame: 2 years
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Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
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2 years
|
Mean time to radiological resolution
Time Frame: 2 years
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Radiological resolution will be defined as decreased cecal diameter to less than 9cm
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2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Intestinal Obstruction
- Intestinal Pseudo-Obstruction
- Ileus
- Syndrome
- Colonic Pseudo-Obstruction
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics
Other Study ID Numbers
- 12731
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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