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

Postoperative Pain Clinical Trial

Official title:

A Prospective, Randomized, Double-blind, Placebo-controlled, Crossover Trial of Epidural Analgesia Versus a Surgically-placed Fascia Iliaca Compartment Catheter for Postoperative Pain After Periacetabular Osteotomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01835106
• Other study ID #: 3650
• Status: Withdrawn
• Phase: N/A
• First received: April 16, 2013
• Last updated: August 9, 2017
• Start date: April 2013
• Est. completion date: April 2013

Study information

• Verified date: August 2017
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Epidural catheter is used postoperatively

• Fascia iliaca compartment catheter is used postoperatively

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days until all pre-defined readiness-to-discharge criteria for hip surgery are met	Numerical pain rating score <4 at rest, and <6 with movement,; Independence from intravenous opioids for 12 hours, and; Ambulation at least 30 m, without a time limit	1-5 days