Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
04/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr FA Levins

ORCID ID

Contact details

Anaesthetics
Selly Oak Hospital
Birmingham
B29 6JD
United Kingdom

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.
Kendall’s 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
Kendall’s 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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes