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WithdrawnNCT01835106Updated Aug 10, 2017

Efficacy of an Epidural Versus a Fascia Iliaca Compartment Catheter After Hip Surgery

An interventional study of Epidural catheter is used postoperatively and Fascia iliaca compartment catheter is used postoperatively in Postoperative Pain, sponsored by Boston Children's Hospital. Withdrawn at 1 site in United States. Open to participants aged 15 Years to 35 Years. Per ClinicalTrials.gov, last updated 2017-08-10.

Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The study was proposed but never started due to other commitments
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
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Study summary

The investigators are investigating two ways of treating pain after hip surgery. One way is though a thin tube (called a catheter), and it is placed into the back so that pain-numbing drugs can reach the nerves near the backbone. This is called an "epidural" catheter. Another way is to place the catheter close to the hip, where the surgery is done, so that the pain-numbing drugs can reach some of the nerves more locally. This is called a "fascia iliaca compartment" catheter.

The investigators do not know which way is best to treat pain, or has fewer side effects, or allows a patient to leave hospital faster. Usually, patients would receive only one type of catheter for pain relief. To do this comparison, the investigators would place both catheter types, so that patients help us tell which one works better.

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Conditions studied

  • Postoperative Pain

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Keywords

  • Postoperative Care
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

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Lead sponsor

Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 151 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Weight >40 kg
  • Radiographic evidence of hip dysplasia amenable to unilateral surgical treatment by periacetabular osteotomy
  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale >4/20
  • Age between 15 and 35 years
  • Good or excellent preoperative joint congruency

Exclusion criteria

Exclusion Criteria:

  • Hematologic or neurologic contraindications to epidural catheter placement
  • Significant renal, hepatic, or cardiac disease
  • Peptic ulcer disease
  • Bleeding disorders
  • Severe asthma
  • Hypersensitivity to non-steroidal antiinflammatory drugs
  • Developmental delay
  • History of substance abuse
  • Chronic opioid use
  • Chronic pain in non-hip locations
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Epidural

    Epidural catheter is used postoperatively

    Procedure: Epidural catheter is used postoperatively

  • Experimental
    Fascia Iliaca Compartment

    Fascia iliaca compartment catheter is used postoperatively

    Procedure: Fascia iliaca compartment catheter is used postoperatively

Interventions

  • ProcedureEpidural catheter is used postoperatively
  • ProcedureFascia iliaca compartment catheter is used postoperatively
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What researchers measure

Primary outcomes

  1. Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met

    1. Numerical pain rating score \<4 at rest, and \<6 with movement, 2. Independence from intravenous opioids for 12 hours, and 3. Ambulation at least 30 m, without a time limit

    Time frame: 1-5 days

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Study locations

1 site
  • Boston Children's Hospital
    Boston, Massachusetts 02115, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01835106
Lead sponsor
Boston Children's Hospital
Responsible party
Luke Y. Wang (Instructor in Anesthesia, Boston Children's Hospital) — Principal investigator
First posted
Apr 18, 2013
Start date
Apr 2013
Primary completion
Apr 2013
Completion
Apr 2013
Last update
Aug 10, 2017

Study contacts

Luke Y Wang, MD
principal investigator · Boston Children's Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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