Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000502639
Ethics application status
Approved
Date submitted
14/04/2014
Date registered
12/05/2014
Date last updated
12/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Combined Local Infiltration Analgesia and Femoral Nerve Blocks in Total Knee Replacements. A Prospective Randomised Controlled Trial
Scientific title
In patients undergoing elective primary unilateral total knee replacements (TKR), does the use of femoral nerve blocks compared to local infiltration analgesia (LIA) or compared to combined femoral nerve blocks and LIA; produce different outcomes in time to post anaesthesia care unit (PACU) and hospital discharge, time to mobilisation, and post-operative opiate consumption and pain scores.
Secondary ID [1] 284441 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
FEMLOC-KNEE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis and other conditions leading to total knee replacement 291649 0
Pain management following total knee replacement. 291703 0
Condition category
Condition code
Anaesthesiology 292032 292032 0 0
Pain management
Musculoskeletal 292033 292033 0 0
Osteoarthritis
Surgery 292034 292034 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 2 - Local infiltration analgesia and placebo femoral nerve block.
Arm 3 - Combined femoral nerve block and local infiltration analgesia.

Local Infiltration Analgesia:
The drugs infiltrated into the joint will comprise: 150ml 0.2% ropivacaine (Arm 2), 130ml 0.2% ropivacaine plus 20ml normal saline (Arm 3). 1ml 1:1000 adrenaline (Arm 2 and 3). 30mg ketorolac (Arm 2 and 3).

Prior to implantation of the components, the posterior capsule will be infiltrated with the mixture. The synovium over the posterior cruciate ligament (PCL) in the notch as well as the medial and lateral collateral areas will be infiltrated. Following implantation of the new joint further injection into the capsule and over the anterior aspect will be conducted. The fat pad, which is richly innervated, will also be injected. Further infiltration will be carried out subcutaneously prior to skin closure, followed by injection into the joint as a bolus of any residual mixture.

Femoral Nerve Block:
Performed post induction of anaesthesia with the aid of ultrasound identification of the femoral nerve.
Injection of 20ml normal saline (Arm 2), or 20ml 0.2% ropivacaine (Arm 3) around the nerve, with a pool of drug/placebo administered immediately adjacent to either the posterolateral or anterior aspects.
Intervention code [1] 289190 0
Treatment: Drugs
Comparator / control treatment
Arm 1 – Femoral nerve block and placebo local infiltration analgesia.

Local Infiltration Analgesia:
The drugs infiltrated into the joint will comprise: 150ml normal saline (Arm 1),

Prior to implantation of the components, the posterior capsule will be infiltrated with the mixture. The synovium over the posterior cruciate ligament (PCL) in the notch as well as the medial and lateral collateral areas will be infiltrated. Following implantation of the new joint further injection into the capsule and over the anterior aspect will be conducted. The fat pad, which is richly innervated, will also be injected. Further infiltration will be carried out subcutaneously prior to skin closure, followed by injection into the joint as a bolus of any residual mixture.

Femoral Nerve Block:
Performed post induction of anaesthesia with the aid of ultrasound identification of the femoral nerve.
Injection of 20ml 0.5% ropivacaine (Arm 1) around the nerve, with a pool of drug/placebo administered immediately adjacent to either the posterolateral or anterior aspects.
Control group
Active

Outcomes
Primary outcome [1] 291917 0
To determine whether there is a statistically significant difference in TKR patients who have received single shot Femoral Nerve Blocks (FNB) or LIA, used alone or in combination, when comparing highest pain scores using a 10 point numeric rating scale.
Timepoint [1] 291917 0
During time in Post Anasthesia Care Unit (PACU), at 4, 24 and 48 hours, and at hospital discharge.
Secondary outcome [1] 307807 0
To determine whether there is a statistically significant difference in TKR patients who have received single shot FNB or LIA, used alone or in combination, in time to mobilisation.
Timepoint [1] 307807 0
Time to mobilisation during hospital admission
Secondary outcome [2] 307808 0
To determine whether there is a statistically significant difference in TKR patients who have received single shot FNB or LIA, used alone or in combination, in time to discharge from PACU.
Timepoint [2] 307808 0
Time to discharge from PACU
Secondary outcome [3] 307809 0
To determine whether there is a statistically significant difference in TKR patients who have received single shot FNB or LIA, used alone or in combination, in time to hospital discharge.
Timepoint [3] 307809 0
Time of hospital discharge
Secondary outcome [4] 307810 0
To determine whether there is a statistically significant difference in the analgesic requirements associated with TKR when comparing the use of single shot FNBs and LIA, used alone or in combination, as determined by total quantity of opiates administered to the patient.
Timepoint [4] 307810 0
During time in PACU, at 4,12,24 and 48 hours, and at hospital discharge.

Eligibility
Key inclusion criteria
i. Elective primary unilateral TKR performed at NGH
ii. Patients who consent to participate in the study
iii. Ability to comprehend pain scoring and ability to use PCA machine
iv. American Society of Anesthesiologists (ASA) Physical Status I-III
v. Patients aged 18-85 years
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Patients who lack capacity, or are unwilling, to consent to the study
ii. Patients with pre-existing chronic pain syndromes
iii. Patients with opioid tolerance (opioid consumption >30mg oral morphine or equivalent per day)
iv. Chronic gabapentin or pregabalin analgesic therapy
v. Patients with known contraindication, allergy, intolerance or previous reaction to any of the drugs being administered
vi. Inability to walk independently prior to TKR
vii. Body Mass Index (BMI) >40 kg/m2
viii. Patients <18 years of age
ix. Patients who are pregnant
x. Patients who have dementia

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be identified by a clinical nurse consultant (orthopaedics) as being eligible for the study, around the time of their operating theatre booking, based on the set inclusion and exclusion criteria.
A cover letter from the Principal Investigator will express an invitation to participate in the trial and will refer the patients to the Patient Information and Consent Form (PICF). This letter and PICF will be mailed in the same pack as the standard letter/information pack relating to the surgery itself.

Patients will be given time to consider the information (1-2 weeks), after which they will be contacted by the Principal or Associate Investigator or a trained research assistant doctor by telephone to discuss all aspects of the trial and answer any questions. Informed verbal consent would be gained at that point. Informed written consent will be gained upon admission to hospital for the TKR, by either the Principal or Associate Investigator.
Once consented, patient’s names are placed on a randomization sheet and are allocated to group A,B or C, which correspond to the three study arms. Based on their allocation, the non-investigator clinical nursing staff will prepare the drug pack for the patient’s TKR prior to the operation. The pack will be left in the theatre medication fridge with the patient’s name, date of birth, address and UR number on it. The pack will then be retrieved by the anaesthetist immediately prior to the operation. The drug packs for the three arms will appear identical, ensuring blinding of the study. Once all data for the study has been collected, the un-blinding form which has been held by the Operating Theatre Nurse Unit Manager will be sent to statistician appointed to analyse the data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by a blocked permuted randomisation method, producing codes for participants, and selection based on the randomisation sequence. Randomisation will be performed by an independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using a propriety statistical package (STATA version 12.0). Data will be organised and trends reported using standard descriptive statistics e.g. mean (SD), median (IRQ) and/or proportions. More detailed inferential analysis will be done using either standard comparative (Mann-Whitney) or regression techniques that take into account the non-normal and/or categorical nature of data. All data will be analysed on an intention to treat basis. Where appropriate, the level of significance will be set at P<0.05.

A minimum sample size per group of 21 was calculated using a student T test with a two tailed hypothesis. This was based on an intention to detect differences between groups of 1 point on the numerical pain score, with a standard deviation of 1.1, a statistical power level of 0.8 and a p-value of 0.05. Previous studies have suggested that a change in pain score of 1 is significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2014
Actual
Date of last participant enrolment
Anticipated
1/05/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2329 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 8004 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 289092 0
Hospital
Name [1] 289092 0
Private Practice Trust Fund - Nambour General Hospital
Country [1] 289092 0
Australia
Primary sponsor type
Hospital
Name
Nambour General Hospital
Address
43 Hospital Road, Nambour, 4560, Queensland
Country
Australia
Secondary sponsor category [1] 287753 0
None
Name [1] 287753 0
Address [1] 287753 0
Country [1] 287753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290879 0
Royal Brisbane and Women’s Hospital Human Research Ethics Committee
Ethics committee address [1] 290879 0
Royal Brisbane and Women’s Hospital, Level 7, Block 7, Butterfiled Street, Herston, Queensland, 4029
Ethics committee country [1] 290879 0
Australia
Date submitted for ethics approval [1] 290879 0
Approval date [1] 290879 0
05/03/2014
Ethics approval number [1] 290879 0
HREC/13/QRBW/446

Summary
Brief summary
Total knee replacements (TKRs) are one of the most painful orthopaedic procedures and are associated with a protracted recovery period.

Multiple techniques are utilised for pain relief and these include femoral nerve blocks (FNBs) and high volume local infiltration analgesia (LIA), the superiority of either is largely contentious.

This study aims to assess the differences in several outcomes for patients undergoing total knee replacement using single shot FNBs and LIA. This is a prospective, blinded, single centre randomised controlled trial at Nambour General Hospital, in Queensland, Australia.

Ninety (90) patients having TKRs will be sought during their visit to the Pre-Anaesthetic Evaluation Unit (PAEU) and assessed against the eligibility criteria. Inclusion criteria are patients who consent to participate in the study; ability to comprehend pain scoring and ability to use PCA machine; elective primary unilateral TKR performed at NGH; American Society of Anesthesiologists (ASA) Physical Status I-III; and patients aged 18-85 years. The exclusion Criteria are patients who lack capacity, or are unwilling, to consent to the study; patients with pre-existing chronic pain syndromes; patients with opioid tolerance (opioid consumption >30mg oral morphine or equivalent per day; chronic gabapentin or pregabalin analgesic therapy; patients with known contraindication, allergy, intolerance or previous reaction to any of the drugs being administered; inability to walk independently prior to TKR; Body Mass Index >40 kg/m2; patients <18 years of age; patients who are pregnant; and patients who have dementia.

Participants will be randomly selected using a blocked permuted randomisation method for Arm 1 – Single Shot FNB and placebo LIA, Arm 2 – LIA and placebo FNB, or Arm 3 – Single Shot FNB and LIA. The trial will be double-blinded.

The trial looks to determine how explanatory variables (FNB, LIA) relate to total opiate consumption and highest pain scores in the immediate post-operative recovery period and at 4/12/24/48 hours (4/24/48 hours for pain scores) post-operatively and at hospital discharge, time to Post-Anaesthesia Care Unit (PACU) and hospital discharge, and time to mobilisation (outcome variables).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47734 0
Dr John Beck
Address 47734 0
51/23 Playfield St, Chermside, Brisbane, Queensland, 4032.

Affiliations:
1) Nambour General Hospital, Queensand, Australia
2) University of Queensland, Sunshine Coast Clinical School, Australia
Country 47734 0
Australia
Phone 47734 0
+61 7 5470 5631
Fax 47734 0
Email 47734 0
[email protected]
Contact person for public queries
Name 47735 0
Dr John Beck
Address 47735 0
51/23 Playfield St, Chermside, Brisbane, Queensland, 4032.

Affiliations:
1) Nambour General Hospital, Queensand, Australia
2) University of Queensland, Sunshine Coast Clinical School, Australia
Country 47735 0
Australia
Phone 47735 0
+61 7 5470 5631
Fax 47735 0
Email 47735 0
[email protected]
Contact person for scientific queries
Name 47736 0
Dr John Beck
Address 47736 0
51/23 Playfield St, Chermside, Brisbane, Queensland, 4032.

Affiliations:
1) Nambour General Hospital, Queensand, Australia
2) University of Queensland, Sunshine Coast Clinical School, Australia
Country 47736 0
Australia
Phone 47736 0
+61 7 5470 5631
Fax 47736 0
Email 47736 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.