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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02702661
Other study ID # A092336
Secondary ID
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


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
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