Trial Outcomes & Findings for Uniport and Multiport Epidural Catheters in Post-surgical Patients (NCT NCT02159560)

Last Updated: 2025-10-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

240 participants

Primary outcome timeframe

72 hours

Results posted on

2025-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Enrolled STARTED	120	120
Enrolled COMPLETED	83	83
Enrolled NOT COMPLETED	37	37
Analyzed STARTED	83	83
Analyzed COMPLETED	76	79
Analyzed NOT COMPLETED	7	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Uniport and Multiport Epidural Catheters in Post-surgical Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	End Holed Catheter n=76 Participants 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	Three Holed Catheter n=79 Participants 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	Total n=155 Participants Total of all reporting groups
Age, Continuous	62.7 years STANDARD_DEVIATION 8.8 • n=5 Participants	58.6 years STANDARD_DEVIATION 10.4 • n=7 Participants	60.3 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	43 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	70 Participants n=5 Participants	71 Participants n=7 Participants	141 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants	45 Participants n=7 Participants	96 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 72 hours

Outcome measures

Outcome measures
Measure	End Holed Catheter n=76 Participants 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	Three Holed Catheter n=79 Participants 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
Epidural Catheter Failure	52 Participants	51 Participants

SECONDARY outcome

Timeframe: 72 hours

number of subjects receiving supplemental treatments required to maintain continual comfort

Outcome measures

Outcome measures
Measure	End Holed Catheter n=76 Participants 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	Three Holed Catheter n=79 Participants 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
Number of Subjects Receiving Supplemental Treatments	30 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 72 hours

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

Outcome measures

Outcome measures
Measure	End Holed Catheter n=76 Participants 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	Three Holed Catheter n=79 Participants 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
Median Dose of Medication	8 ml per hour Interval 7.0 to 10.0	9 ml per hour Interval 7.0 to 10.0

Adverse Events

End Holed Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Three Holed Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Hess

Beth Israel Deaconess Medical Center

Phone: 6176673112

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place