Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265178818
Study information
Scientific title
Intra- and Post-operative analgesia for patients undergoing surgery for hip fracture - role of Fascia Illiaca Compartment Block
Acronym
Study hypothesis
1. Analgesia technique for patients undergoing surgery for hip fracture?
2. Is better pain relief associated with any other clinical benefit?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Analgesia
Intervention
Purpose:
To see whether analgesic efficacy of Fascia Iliaca Compartment Block (FICB) is better than that of Morphine during and post hip fracture surgery
Theoretical framework:
The commonly used nerve blocks for patients undergoing hip fracture surgery are:
1. Lumbar plexus block
2. Psoas compartment block
3. 3-in-1 block
1 and 2 require change in patient position and the potential for complications is greater. They have not been shown to be more effective than 3-in-1 block which does not need change in position and has lesser potential for complications. FICB is a simpler technique of blocking the same nerves as the 3-in-1 block was first described in 1989 and is commonly used in children undergoing hip or thigh surgery. Lt has been studied in adults also and shown to have analgesic efficacy similar to that of 3-in-1 block in hip, thigh and knee surgeries but the number of patients undergoing hip surgery was small and the type of hip surgery was different. FICB has been shown to have good analgesic efficacy in the pre-operative care of patients with hip fracture. For two specific kinds of hip surgery namely Dynamic f-tip Compression Screw and Cannulated Screw fixation FIGB may be more suitable than 3-in-1 block as it blocks one of the nerves (lateral cutaneous nerve of thigh) responsible for pain from this surgery more reliably FICB is quicker, easier and cheaper than 3-in-1 block and could be repeated on the ward it necessary The potential for complications is lower than that of 3-in-1 block. To our knowledge there are no ACTS assessing the efficacy of FICB compared to Morphine in this group of patients.
It is not clear from previous studies whether nerve blocks provide any additional clinical benefit over conventional pain killers apart from reducing their requirements. Our choice of secondary outcome measures is based on conclusions made in a systematic review on nerve blocks in hip fractures (Cochrane review) and a recent study which performed mortality analysis in hip fracture and discussed its implications on design of future trials. We hope to make a small contribution to significant work being done in this field by providing full reporting of outcome measures.
Design and Methodology:
Randomised Controlled Trial - Study group will have FICB for analgesia and the control group will have Morphine. The control arm is essential because Morphine is the most common analgesic used in these patients perioperatively.
Blinding - Patients and staff responsible for assessing analgesic efficacy will be blind to the choice of technique. This is to eliminate placebo effect and observer bias.
Organisation - 40 adult patients of ASA grades 1, 2 & 3 admitted to Selly Oak Hospital with hip fracture and scheduled for DHS or Compression screw fixation will be recruited after obtaining consent. They will then be randomly allocated to two groups of 20 each. To detect differences in analgesic requirements during the first 24 hours after surgery at the 5% significance level with 80% power, 18 patients will be required in each group. This calculation was based on previous studies assessing efficacy of nerve blocks post hip fracture surgery. We decided to recruit 20 in each group to make some allowance for dropouts if any.
Each patient will have a standard pre-operative assessment, standard monitoring and recovery care and will have assessments at 1,3,6 and 24 hours post-op. Thereafter data collection will be on a daily basis until 30 days post-op./discharge/death whichever is earlier-Our hospital already has a framework for data collection (Integrated Care Pathway). For our study we will be using the same data.
Statistical analysis:
Test Null Hypothesis
SPSS software will be used to perform statistical analysis. The following tests will be used to analyse data for significance:
't' test or Mann Whitney test for continuous data depending on distribution.
Kendalls tau-b test for ordinal data
Fishers exact test for nominal data
McNemars test for intra-group analysis for ordinal data at various time points
Kendalls tau-b test for inter-group analysis for ordinal data at various time points
P value <0.05 will be considered significant.
Inconvenience:
Interview for recruitment. All assessments are standard and no different from other patients.
8enefits:
A tow risk alternative analgesic technique which may result in reduction of conventional analgesic use and also their side effects.
The study is expected to lasts to 6 months to get the required no, of patients and a further month to complete follow-up.
Data analysis and reporting will take one more month.
There will not be any interim analyses.
We aim to present our findings in our hospital and in the region and also to publish our results in a peer reviewed journal.
We will also aim to provide feedback to research participants in the form of letters.
Intervention type
Drug
Phase
Not Specified
Drug names
morphine
Primary outcome measures
Total dose of morphine required during first 24 hours post-op.
Secondary outcome measures
1. Time to first dose of morphine post-op
2. Pain scores in recovery room and at 13, 16 and 24 hours post-op, intra- and inter-group analysis
3. Time to first appropriate response to verbal commands post-op
4. Time to discharge from recovery room
5. Occurrence of nausea and vomiting in recovery and no. of episodes during the first 24 hours post-op
6. Total dose of Cyclizine required in the first 24 hours post-op.
7. Need for Granisetron during the first 24 hours post-op.
8. Sedation Scores at 1,3,6 and 24 hours post-op.
9. Mental Test Scores at 1,3,6 and 24 hours post-op. compared to pre-op score, intra- and inter-group analysis.
10. Other: unlikely to find significant difference because of sample size but full reporting of morbidity, complications, rehabilitation outcomes and mortality will be useful. There has been no involvement of patient groups, research participants or communities in the design of this study.
Overall trial start date
04/04/2006
Overall trial end date
04/04/2007
Reason abandoned
Eligibility
Participant inclusion criteria
All patients posted for hip fracture surgery are potential participants. Their notes will be screened for defined exclusion criteria. It there are none, they will be approached in the ward by one of the research investigators who will then explain the planned research, its potential benefits and risks and will give an information leaflet to read and sufficient time to think over. They will then be approached again on the day of surgery. It by then the patient has decided to participate, we will make sure they have understood the information provided and then written consent will be obtained. The patients will also be informed that they are tree to withdraw from the study at any time without having to give any explanation. We will also ensure continued consent during the study period.
In our study, randomisation will be done after recruitment.
All adult ASA Physical status 1, 2 and 3 patients with hip fracture posted for DHS or Cannulated screw fixation.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
1. Dementia/confusion as it is difficult to assess pain relief.
2. Pre-operative chest infection and/or poor respiratory function - Temperature 380C or more, white cell count> 11000 mm3, Respiratory rate > 25 per minute, auscultation and or chest x-ray evidence, Sp02 < 90 % on air
3. Congestive Cardiac Failure (CCF)
4. Bed bound or use of 2 or more aids for mobilisation pre-fracture
5. Malignancy
6. Coagulopathy
7. Known or suspected allergy to Ropivacaine and/or Morphine
8. Local infection at the site where the block is to be performed
9. Refusal of permission to approach General Practitioner
Justification for these exclusion criteria:
Pre-fracture poor mental status, poor mobility, CCF, poor respiratory function and malignancy are independent risk factors for poor outcome following hip fracture The morbidity and mortality in this group is high and unlikely to be influenced by choice of technique. The others are standard contra-indications for any nerve block technique.
Recruitment start date
04/04/2006
Recruitment end date
04/04/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetics
Birmingham
B29 6JD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary