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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04600427
Other study ID # 12731
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2023

Study information

Verified date September 2021
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Epidural anesthesia
T11-12 epidural blockade with 0.25% bupivacaine continuous infusion.

Locations

Country Name City State
Canada St. Joseph's Healthcare Hamilton Ontario

Sponsors (1)

Lead Sponsor Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment rate Larger study will be considered feasible if a recruitment rate of 1 patient per month is achieved. 2 years
Primary 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
Primary 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
Primary 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
Primary 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
Primary Rate of radiological resolution Radiological resolution will be defined as decreased cecal diameter to less than 9cm 2 years
Secondary Readmission rate Rate of readmission to hospital following intervention and subsequent discharge will be reported as secondary safety outcomes. 30 days
Secondary Length of stay in hospital Length of stay in hospital following placement of epidural anesthesia 30 days
Secondary Mean time to clinical resolution Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating. 2 years
Secondary Mean time to radiological resolution Radiological resolution will be defined as decreased cecal diameter to less than 9cm 2 years
See also
  Status Clinical Trial Phase
Completed NCT03386136 - Therapeutic Oxygen for Gastrointestinal Atony (TOGA) Phase 1
Recruiting NCT04951726 - Neostigmine Route for Acute Colonic Pseudo Obstruction Phase 4