PRCT of FICB vs LAI for Hip Arthroscopy

Femoroacetabular Impingement Clinical Trial

Official title:

Fascia Iliaca Compartment Block and Local Anaesthetic Infiltration for Pain Control Following Hip Arthroscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702661
• Other study ID #: A092336
• Status: Completed
• Phase: N/A
• First received: February 24, 2016
• Last updated: March 10, 2016
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: March 2016
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A prospective randomised controlled trial involving patients undergoing hip arthroscopy. Participants were randomised to receiving either Fascia Iliaca Compartment Block (FICB) or Local Anaesthetic Infiltration (LAI) of the portal tracts with local anaesthetic. Supplemental analgesia was also used in both groups on an on-demand basis. Pain level is assessed at 1,3,6, and 24 hours post surgery. The primary outcome measure was the post-operative level of pain as assessed by Numeric Pain Score 6 hours after surgery. Secondary outcome measures were the frequency and the dose of morphine and other medications consumed at 1 and 24 hours after surgery as well as any other adverse events relating to pain or medications used for pain relief in both the groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients over the age of 18 years

• Primary elective hip arthroscopy on a native hip for combined soft tissue injuries and FAI pathology

• Able to read, write and communicate in English

Exclusion Criteria:

• Patients who did not want to be involved in the Trial

• Unable to give informed consent

• Previous hip surgery

• Patients younger than 18 years of age

• Chronic opioids users

• Patients known to have an allergy or intolerance to local anaesthetic agents or none steroidal anti-inflammatory medications

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

Intervention

Procedure:
• Fascia Iliaca Compartment Block (FICB)
Fascia Iliaca Compartment Block
• Local Anaesthetic Infiltration (LAI)
Local Anaesthetic Infiltration (LAI) of the portal tracts

Drug:
• Levobupivacaine
Levobupivacaine 0.125% - 40ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of pain as assessed by Numeric Pain Score		6 hours after surgery	No
Secondary	Frequency of morphine consumed		1 and 24 hours after surgery	No
Secondary	Total dose of morphine consumed		1 and 24 hours after surgery	No
Secondary	Total dose of codeine consumed		1 and 24 hours after surgery	No
Secondary	Nausea and Vomiting		1 and 24 hours after surgery	Yes