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Completed

NCT Number: NCT02702661

PRCT of FICB vs LAI for Hip Arthroscopy

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.

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Key information

Conditions

Femoroacetabular Impingement Femoracetabular Impingement Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fascia iliaca compartment block (FICB)

Procedure

Fascia Iliaca Compartment Block

Local Anaesthetic Infiltration (LAI)

Procedure

Local Anaesthetic Infiltration (LAI) of the portal tracts

Levobupivacaine

Drug

Levobupivacaine 0.125% - 40ml

Primary outcomes

  1. Level of pain as assessed by Numeric Pain Score

    Time frame: 6 hours after surgery

Secondary outcomes

  1. Frequency of morphine consumed

    Time frame: 1 and 24 hours after surgery

  2. Total dose of morphine consumed

    Time frame: 1 and 24 hours after surgery

  3. Total dose of codeine consumed

    Time frame: 1 and 24 hours after surgery

  4. Nausea and Vomiting

    Time frame: 1 and 24 hours after surgery

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 9, 2016
Registry last updated
Mar 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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