N/A
N=50
Efficacy of Fascia Iliaca Block Versus Intraoperative Nerve Infiltration During Anterior Hip Replacement Surgery
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT01693900 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Postoperative Pain During PACU Admission — 40; 36 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pre-operative Ultrasound FICB Group (Procedure); Intra-operative FICB Group (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Randy Fayne, DO
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain During PACU Admission |
40; 36 | — |
| PRIMARY Postoperative Pain During Recovery |
25; 26 | — |
| SECONDARY Incidence of Adverse Events |
20; 19 | — |
| SECONDARY Patient Satisfaction With Postoperative Pain Control |
9.7; 8.8 | — |
Summary
Surgical trauma causes nerve sensitization leading to amplification and prolongation of postoperative pain. In experimental studies, pre-injury neural blockade using local anesthetics has been shown to reduce post-injury sensitization of the central nervous system, while similar techniques applied after the injury had less or no effect (FILOS). Investigators have therefore designed this study to examine the timing of FICB (pre-operatively versus intra-operatively) on postoperative pain in patients undergoing anterior hip replacement surgery.
Eligibility Criteria
Inclusion Criteria
- Adults 18-65 years of age
- Female patients must be surgically sterile, postmenopausal or have a negative pregnancy test on the day of surgery
- Willing and able to sign the informed consent approved by the Institutional Review Board (IRB)
- Willing and able to complete the study procedures and pain scales, and to communicate meaningfully in English with study personnel
- Elective anterior hip replacement to be performed at Beaumont Hospital, Royal Oak
- American Society of Anesthesiologists physical status classification 1, 2, and 3 (patients that have either no systemic illness, or mild to moderate systemic disease, eg. asthma, diabetes or hypertension)
Exclusion Criteria
- History of allergy to study medications including ropivacaine and other local anesthetic agents of the amide-type
- Enrollment in concurrent research study
- Female patients who are pregnant or lactating, or who have a positive urine pregnancy test
- Opioid tolerant, ie, A patient taking a narcotic > 30mg per day morphine equivalent. (Source: www.globalrph.com/narcotic.cgi) for pain in the 2 months prior to surgery
- A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conducts of the study, or interferes with the pain assessments
- Previous hip arthroplasty (partial or total) of the index hip
- History of illicit drug use, or prescription medicine or alcohol abuse within the past 2 years
Data sourced from ClinicalTrials.gov (NCT01693900). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.