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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN18887807 |
Date of registration:
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28/09/2007 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A comparison of psoas compartment and subarachnoid blocks for 'fast track' total hip arthroplasty
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Scientific title:
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A comparison of psoas compartment and subarachnoid blocks for 'fast track' total hip arthroplasty |
Date of first enrolment:
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01/08/2006 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN18887807 |
Study type:
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Interventional |
Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Rakesh
Tandon |
Address:
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Consultant Anaesthetist
Department of Anaesthetics
Box 93
Addenbrooke's Hospital
CB2 2QQ
Cambridge
United Kingdom |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Surgery: Total hip arthroplasty Surgery Total hip arthroplasty
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Intervention(s)
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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
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Primary Outcome(s)
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Reduction in peri-operative morphine consumption
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Secondary Outcome(s)
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1. Early mobility 2. Early rehabilitation
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Secondary ID(s)
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N0544183632
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Source(s) of Monetary Support
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Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding
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Results
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Results available:
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Date Posted:
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Date Completed:
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