Ogilvie SyndromeNCT04600427
Epidural for Ogilvie's Syndrome
A study testing Epidural anesthesia in people with Ogilvie Syndrome and Colonic Pseudo-Obstruction, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ogilvie Syndrome, Colonic Pseudo-Obstruction
- What is being tested?
- Epidural anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Blockade for Ogilvie's Syndrome: A Prospective Pilot Study
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.
Read the 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.
- Conditions
- Ogilvie Syndrome, Colonic Pseudo-Obstruction
- Being tested
- Epidural anesthesia
- Medical subject headings
- Colonic Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural anesthesiaProcedure or surgery
T11-12 epidural blockade with 0.25% bupivacaine continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Larger study will be considered feasible if a recruitment rate of 1 patient per month is achieved.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Rate of radiological resolution
Radiological resolution will be defined as decreased cecal diameter to less than 9cm
Measured: 2 years
Secondary outcomes (4)
Readmission rate
Rate of readmission to hospital following intervention and subsequent discharge will be reported as secondary safety outcomes.
Measured: 30 days
Length of stay in hospital
Length of stay in hospital following placement of epidural anesthesia
Measured: 30 days
Mean time to clinical resolution
Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
Measured: 2 years
Mean time to radiological resolution
Radiological resolution will be defined as decreased cecal diameter to less than 9cm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Sep 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Why it stopped: This was a pilot study aimed at assessing feasibility of further assessing epidural as a treatment for Ogilvie's. There were no eligible patients that were enrolled throughout the two years of accrual. Thus we deemed the study not feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ogilvie SyndromeStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, single centre study
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600427
- Sponsor's protocol ID
- 12731
- Status last verified
- Sep 2021
- First submitted
- 19 Oct 2020
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Blockade for Ogilvie's Syndrome: A Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT04600427
- Acronym / sponsor ID
- 12731
- Conditions
- Ogilvie Syndrome, Colonic Pseudo-Obstruction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This was a pilot study aimed at assessing feasibility of further assessing epidural as a treatment for Ogilvie's. There were no eligible patients that were enrolled throughout the two years of accrual. Thus we deemed the study not feasible.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, single centre study
| Arm | Type | Receives |
|---|---|---|
| Epidural anesthesia | Experimental | Procedure: Epidural anesthesiaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural anesthesiaT11-12 epidural blockade with 0.25% bupivacaine continuous infusion. | Procedure or surgery | Epidural anesthesia |
Primary outcome
Recruitment rate
Time frame: 2 years
Larger study will be considered feasible if a recruitment rate of 1 patient per month is achieved.
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.
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.
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.
Rate of clinical resolution
Time frame: 2 years
Clinical resolution will be defined as passage of flatus and stool with associated resolution of abdominal distention and bloating.
Rate of radiological resolution
Time frame: 2 years
Radiological resolution will be defined as decreased cecal diameter to less than 9cm
4 secondary outcomes
Readmission rate
Time frame: 30 days
Length of stay in hospital
Time frame: 30 days
Mean time to clinical resolution
Time frame: 2 years
Mean time to radiological resolution
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural anesthesia in people with Ogilvie Syndrome and Colonic Pseudo-Obstruction, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.