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

NCT01835106 | Withdrawn

• 1 other identifier: 3650
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

Postoperative Care

Outcome Measures

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

  1-5 days

Study Arms (2)

Epidural

ACTIVE COMPARATOR

Epidural catheter is used postoperatively

Procedure: Epidural catheter is used postoperatively

Fascia Iliaca Compartment

EXPERIMENTAL

Fascia iliaca compartment catheter is used postoperatively

Procedure: Fascia iliaca compartment catheter is used postoperatively

Interventions

Epidural catheter is used postoperatively PROCEDURE

Epidural

Fascia iliaca compartment catheter is used postoperatively PROCEDURE

Fascia Iliaca Compartment

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, 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

Study Officials

• Luke Y Wang, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Anesthesia

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 10, 2017

Record last verified: 2017-08

Locations

US (1)