Uniport and Multiport Epidural Catheters in Post-surgical Patients

NCT02159560 | Completed Results FDA Device

• 1 other identifier: 2014P000085
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  72 hours

Secondary Outcomes (1)

• Number of Subjects Receiving Supplemental Treatments

  72 hours

Other Outcomes (1)

• Median Dose of Medication

  72 hours

Study Arms (2)

End holed catheter

ACTIVE COMPARATOR

Single holed, end holed epidural catheter

Device: Epidural catheter

Three holed catheter

ACTIVE COMPARATOR

closed ended, three side holed epidural catheter

Device: Epidural catheter

Interventions

Epidural catheter DEVICE

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

End holed catheter; Three holed catheter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Philip Hess
• Organization: Beth Israel Deaconess Medical Center

phess@bidmc.harvard.edu

6176673112

Study Officials

• Philip E Hess, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patient, evaluator, statistician all blinded to assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Obstetric Anesthesia

Model Details: Randomized, double-blinded comparison of two epidural catheter designs

Study Record Dates

• First Submitted: May 19, 2014
• First Posted: June 10, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 29, 2025
• Results First Posted: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)