PRCT of FICB vs LAI for Hip Arthroscopy

NCT02702661 | Completed

• 1 other identifier: A092336
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Femoroacetabular Impingement

Keywords

Fascia Iliaca Block; Local Anaesthetic Infiltration; Hip Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Level of pain as assessed by Numeric Pain Score

  6 hours after surgery

Secondary Outcomes (4)

• Frequency of morphine consumed

  1 and 24 hours after surgery

• Total dose of morphine consumed

  1 and 24 hours after surgery

• Total dose of codeine consumed

  1 and 24 hours after surgery

• Nausea and Vomiting

  1 and 24 hours after surgery

Study Arms (2)

Procedure - FICB

EXPERIMENTAL

Fascia Iliaca Block following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

Procedure: Fascia Iliaca Compartment Block (FICB); Drug: Levobupivacaine

Procedure - LAI

ACTIVE COMPARATOR

Local Anaesthetic Infiltration following Hip Arthroscopy - Drug - Levobupivacaine 0.125% - 40ml

Procedure: Local Anaesthetic Infiltration (LAI); Drug: Levobupivacaine

Interventions

Fascia Iliaca Compartment Block (FICB) PROCEDURE

Fascia Iliaca Compartment Block

Procedure - FICB

Local Anaesthetic Infiltration (LAI) PROCEDURE

Local Anaesthetic Infiltration (LAI) of the portal tracts

Procedure - LAI

Levobupivacaine DRUG

Levobupivacaine 0.125% - 40ml

Procedure - FICB; Procedure - LAI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead

MeSH Terms

Conditions

Femoracetabular Impingement

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Vikas Khanduja, MA, FRCS (Orth)

  Cambridge University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopaedic Surgeon & Associate Lecturer

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 11, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share