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Uniport and Multiport Epidural Catheters in Post-surgical Patients

Uniport and Multiport Epidural Catheters in Post-surgical Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02159560
Enrollment
240
Registered
2014-06-10
Start date
2014-06-30
Completion date
2021-12-31
Last updated
2025-10-29

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

Conditions

Post-operative Pain

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.

Interventions

The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter

Sponsors

Beth Israel Deaconess Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

patient, evaluator, statistician all blinded to assignment

Intervention model description

Randomized, double-blinded comparison of two epidural catheter designs

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epidural Catheter Failure72 hoursThe 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

MeasureTime frameDescription
Number of Subjects Receiving Supplemental Treatments72 hoursnumber of subjects receiving supplemental treatments required to maintain continual comfort

Other

MeasureTime frameDescription
Median Dose of Medication72 hoursMedian dose (per hour) of medication required to maintain comfort

Countries

United States

Participant flow

Participants by arm

ArmCount
End Holed Catheter
Single holed, end holed epidural catheter Epidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter
76
Three Holed Catheter
closed ended, three side holed epidural catheter Epidural catheter: The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter
79
Total155

Baseline characteristics

CharacteristicTotalThree Holed CatheterEnd Holed Catheter
Age, Continuous60.3 years
STANDARD_DEVIATION 9.7
58.6 years
STANDARD_DEVIATION 10.4
62.7 years
STANDARD_DEVIATION 8.8
Ethnicity (NIH/OMB)
Hispanic or Latino
14 Participants8 Participants6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
141 Participants71 Participants70 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
17 Participants10 Participants7 Participants
Race (NIH/OMB)
Black or African American
31 Participants17 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
11 Participants7 Participants4 Participants
Race (NIH/OMB)
White
96 Participants45 Participants51 Participants
Sex: Female, Male
Female
79 Participants43 Participants36 Participants
Sex: Female, Male
Male
76 Participants36 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 760 / 79
other
Total, other adverse events
0 / 760 / 79
serious
Total, serious adverse events
0 / 760 / 79

Outcome results

Primary

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.

Time frame: 72 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
End Holed CatheterEpidural Catheter Failure52 Participants
Three Holed CatheterEpidural Catheter Failure51 Participants
Secondary

Number of Subjects Receiving Supplemental Treatments

number of subjects receiving supplemental treatments required to maintain continual comfort

Time frame: 72 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
End Holed CatheterNumber of Subjects Receiving Supplemental Treatments30 Participants
Three Holed CatheterNumber of Subjects Receiving Supplemental Treatments29 Participants
Other Pre-specified

Median Dose of Medication

Median dose (per hour) of medication required to maintain comfort

Time frame: 72 hours

ArmMeasureValue (MEDIAN)
End Holed CatheterMedian Dose of Medication8 ml per hour
Three Holed CatheterMedian Dose of Medication9 ml per hour

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