Epidural for Ogilvie's Syndrome

NCT04600427 | Withdrawn DMC

• 1 other identifier: 12731
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Epidural anesthesia may represent a safe and effective pharmacological tool in the management of Ogilvie's Syndrome. This pilot study aims to demonstrate feasibility, safety, and efficacy of epidural anesthesia to set the stage for adequately powered future randomized controlled trials (RCTs) in order to assess the efficacy of epidural anesthetic as a pharmacological treatment strategy for Ogilvie's Syndrome. Ultimately, this research may prompt further investigation and establish standardized criteria for managing Ogilvie's Syndrome patients with epidural anesthesia.

Conditions

Ogilvie Syndrome; Colonic Pseudo-Obstruction

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

  Larger study will be considered feasible if a recruitment rate of 1 patient per month is achieved.

  2 years

• Successful epidural insertion

  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.

  2 years

• Follow-up rate

  Larger study will be considered feasible if more than 80% of patients recruited have a full 30 days of follow up data.

  2 years

• Epidural-related morbidity

  . 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.

  30 days

• Rate of clinical resolution

  Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.

  2 years

• Rate of radiological resolution

  Radiological resolution will be defined as decreased cecal diameter to less than 9cm

  2 years

Secondary Outcomes (4)

• Readmission rate

  30 days

• Length of stay in hospital

  30 days

• Mean time to clinical resolution

  2 years

• Mean time to radiological resolution

  2 years

Study Arms (1)

Epidural anesthesia

EXPERIMENTAL

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.

Procedure: Epidural anesthesia

Interventions

Epidural anesthesia PROCEDURE

T11-12 epidural blockade with 0.25% bupivacaine continuous infusion.

Epidural anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Colonic Pseudo-Obstruction

Interventions

Anesthesia, Epidural

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Pseudo-Obstruction; Ileus; Intestinal Obstruction

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, single centre study

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: January 9, 2023

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)