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Uniport and Multiport Epidural Catheters in Post-surgical Patients

Primary Purpose

Post-operative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epidural catheter
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English speaking
  • Surgery in the thorax or upper abdomen
  • Age between 18 and 75
  • Expected use of epidural analgesia for >24 hours

Exclusion Criteria:

  • Contraindication to epidural catheterization
  • Chronic use of opioids
  • Chronic pain
  • Allergy to the standard medications used
  • Body Mass Index >40
  • Delirium
  • Dementia

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

End holed catheter

Three holed catheter

Arm Description

Single holed, end holed epidural catheter

closed ended, three side holed epidural catheter

Outcomes

Primary Outcome Measures

Epidural catheter failure
The primary outcome of the study will be the incidence of failed epidural analgesia, defined as the need to add intravenous opioids or halting or replacing the epidural catheter because of lack of pain control.

Secondary Outcome Measures

number of supplemental treatments
number of supplemental treatments required to maintain continual comfort

Full Information

First Posted
May 19, 2014
Last Updated
March 3, 2022
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02159560
Brief Title
Uniport and Multiport Epidural Catheters in Post-surgical Patients
Official Title
Uniport and Multiport Epidural Catheters in Post-surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators hypothesize that multi-port thoracic epidural catheters will provide superior pain relief when compared to uniport catheters for post-surgical patients.
Detailed Description
Epidural analgesia (pain relief) is an effective treatment for post-surgical acute pain. The factors that determine the effectiveness of pain relief with epidural analgesia have been studied almost exclusively in the lumbar (low back) spaces for obstetrics (childbirth). These factors include the design of the epidural catheter, the type and dose of medications, and the volume of solution used. One of the important issues specific to the catheter design is whether the tip has a one end-hole, or multiple side holes. The number of holes has been suggested to affect the spread of epidural anesthetic over time, especially with low volume solutions. This has been demonstrated in older, stiffer epidural catheter designs, but has not been shown to be true with the newer, flexible epidural catheters. The thoracic (upper back) epidural analgesia is widely employed for a many types of surgical pain. While the mechanism of pain relief is similar to that in the lumbar space, there may be differences between the two sites. Firstly, thoracic catheters tend to use low volume, high concentration medication solutions, which likely do not spread as effectively. Secondly, the thoracic catheters often need to be used for prolonged periods of time. Whereas the typical obstetric epidural is used for less than 12 hours, the post-surgical catheter is typically required for one to three days (or more). Finally, the thoracic space is narrow, with a thinner thecal sac, which might promote a difference in the spread of epidural solution. Thoracic epidural analgesia is routinely used to control post-operative pain for a wide variety of surgical procedures. Based on the improved effectiveness of the one end-hole flexible epidural catheter in obstetrics, this design is commonly used in thoracic epidural analgesia. It has been observed that thoracic epidurals are somewhat less effective after a period of time when compared to the effectiveness of labor epidurals. This may be in part due to the inappropriate assumption that the thoracic epidural space of a post-surgical patient is the same as the lumbar space of a parturient. The investigators seek to determine whether there is a difference in the analgesia provided by a thoracic multi-port epidural catheter when compared to a thoracic uniport epidural catheter as measured by pain scores, medication given for breakthrough pain, and need to add intravenous opioids. As mentioned previously, these catheters have been studied extensively in laboring patients but there is a striking paucity of literature regarding how anesthetic solutions spread in the thoracic epidural spaces of non-pregnant post-surgical patients and how this may be affected by catheter type. If the hypothesis is supported by results, it may change the practice within the study institution, and possibly, on a much larger scale. This study may also provide a foundation for further research into the physiology of the thoracic epidural space, how it differs from the lumbar epidural space, and how a medication solution spreads within this unique space.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blinded comparison of two epidural catheter designs
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
patient, evaluator, statistician all blinded to assignment
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
End holed catheter
Arm Type
Active Comparator
Arm Description
Single holed, end holed epidural catheter
Arm Title
Three holed catheter
Arm Type
Active Comparator
Arm Description
closed ended, three side holed epidural catheter
Intervention Type
Device
Intervention Name(s)
Epidural catheter
Intervention Description
The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter
Primary Outcome Measure Information:
Title
Epidural catheter failure
Description
The primary outcome of the study will be the incidence of failed epidural analgesia, defined as the need to add intravenous opioids or halting or replacing the epidural catheter because of lack of pain control.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
number of supplemental treatments
Description
number of supplemental treatments required to maintain continual comfort
Time Frame
72 hours
Other Pre-specified Outcome Measures:
Title
Mean dose of medication
Description
average dose (per hour) of medication required to maintain comfort
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English speaking Surgery in the thorax or upper abdomen Age between 18 and 75 Expected use of epidural analgesia for >24 hours Exclusion Criteria: Contraindication to epidural catheterization Chronic use of opioids Chronic pain Allergy to the standard medications used Body Mass Index >40 Delirium Dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip E Hess, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Uniport and Multiport Epidural Catheters in Post-surgical Patients

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