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Epidural for Ogilvie's Syndrome

Epidural Blockade for Ogilvie's Syndrome: A Prospective Pilot Study

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04600427
Enrollment
0
Registered
2020-10-23
Start date
2021-09-01
Completion date
2023-08-31
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Pseudo-Obstruction, Ogilvie Syndrome

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.

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.

Interventions

PROCEDUREEpidural anesthesia

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

Sponsors

McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single arm, single centre study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of radiological resolution2 yearsRadiological resolution will be defined as decreased cecal diameter to less than 9cm
Successful epidural insertion2 yearsA 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.
Follow-up rate2 yearsLarger study will be considered feasible if more than 80% of patients recruited have a full 30 days of follow up data.
Epidural-related morbidity30 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.
Rate of clinical resolution2 yearsClinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
Recruitment rate2 yearsLarger study will be considered feasible if a recruitment rate of 1 patient per month is achieved.

Secondary

MeasureTime frameDescription
Length of stay in hospital30 daysLength of stay in hospital following placement of epidural anesthesia
Mean time to clinical resolution2 yearsClinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
Mean time to radiological resolution2 yearsRadiological resolution will be defined as decreased cecal diameter to less than 9cm
Readmission rate30 daysRate of readmission to hospital following intervention and subsequent discharge will be reported as secondary safety outcomes.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026