Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0544183632
Study information
Scientific title
A comparison of psoas compartment and subarachnoid blocks for 'fast track' total hip arthroplasty
Acronym
Study hypothesis
The aim of our study is to compare the reduction in morphine consumption, length of hospital stay and quality of rehabilitation in patients managed with intravenous patient controlled analgesia (PCA) with morphine combined with a subarachnoid block versus PCA morphine combined with a psoas compartment block for total hip replacement.
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: Total hip arthroplasty
Intervention
The aims of our study are to compare, in patients undergoing total hip replacement (THR) operation, the reduction in morphine consumption, length of hospital stay, side effects and quality of rehabilitation in patients managed with intravenous patient controlled analgesia (PCA) with morphine combined with a subarachnoid block versus PCA morphine combined with a psoas compartment block for total hip replacement.
Informed consent will be taken from all patients recruited to the study. General anaesthesia will be administered to all patients in the anaesthetic room.
Two groups of 25 patients each will be required to detect a significant difference in outcome. Patients in both groups will receive morphine intraoperatively (the dose being decided on basis of their weight) and PCA morphine postoperatively.
Patients in Group A will have a psoas compartment block while patients in Group B will have a subarachnoid block. Patients in both the groups will receive PCA morphine for post operative analgesia. All patients will also receive paracetamol and ibuprofen postoperatively if there are no contraindications to use of these medicines. To ensure validity and reproducibility of the study, it is important to ensure that every patient recruited for the study should have an equal chance of being assigned to either of the two groups. This is called randomisation and will be performed by a drawing of a card with a computer-generated number that will assign the patient to either of the two groups. The card will carry a number, which can be cross-referenced to the technique performed. Only this number will appear on the data collection sheet and will be used to identify the patient. The anaesthetist performing the block will not be involved in further intra-operative management of the patient. The surgeons, physiotherapists and nursing staff collecting the data postoperatively will also be blinded to the patient's group.
In the postoperative period, data on morphine consumption as determined by use of the PCA pump will be collected. Pain scores will be recorded by a trained nurse. Hip and knee flexion, straight leg raise and mobility scores will be recorded by the attending physiotherapist. The number of days to discharge from the hospital will also be recorded. The collected data will be statistically analysed for differences between the two groups.
Traditional techniques for THR surgery are associated with significant post-operative pain, which, without adequate analgesia, lead to unnecessary morbidity, and a delay in recovery and subsequent discharge. Regional blockade has reduced the need for opioid analgesia and thereby reduces their potential side effects. Many studies have shown that a regional technique not only reduces opioid requirement but significantly improves a patient's outcome in terms of rehabilitation, analgesia, patient satisfaction and time to discharge. In addition, in hip surgery, regional blockade has been
shown to reduce blood loss and thrombo-embolic events. Psoas compartment and subarachnoid blocks for total hip replacement operation have been evaluated in a few studies but there is lack of consensus on their efficacy in providing pain relief and reducing morphine consumption.
Total hip replacement has been performed for more than forty years with admirable success and is currently a very cost-effective procedure, which contributes significantly to a patient's quality of life. We propose to evaluate effect of psoas compartment and subarachnoid blocks in patients undergoing THR.
Intervention type
Drug
Phase
Not Applicable
Drug names
Morphine
Primary outcome measures
Reduction in peri-operative morphine consumption
Secondary outcome measures
1. Early mobility
2. Early rehabilitation
Overall trial start date
01/08/2006
Overall trial end date
01/08/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. All patients, between the ages of 18 and 85 years undergoing total hip replacement (THR) at the Addenbrooke's NHS Trust
2. ASA physical status I to III
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. ASA greater than III
2. Age below 18 and above 85 years old
3. Weight or BMI exclusion <50 or> 120 kg [BMI <20>35]
4. Inability to use a PCA (dementia, psychiatric problems, intellectual disability)
5. Contraindication to NSAIDs (asthmatics with significant sensitivity to aspirin, renal impairment, severe liver dysfunction, history of gastric ulceration or bleeding)
6. Opioid dependence or chronic pain syndromes
7. Contraindication to neuro-axial blockade or regional techniques - bleeding diathesis, anti-coagulation, absolute local anaesthetic (LA) allergy, localised infection, concurrent peripheral neuropathy or nerve injury
Recruitment start date
01/08/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 2QQ
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
Cambridge Consortium - Addenbrooke's (UK), Own Account 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