A comparison of psoas compartment and subarachnoid blocks for 'fast track' total hip arthroplasty

ISRCTN ISRCTN18887807
DOI https://doi.org/10.1186/ISRCTN18887807
Secondary identifying numbers N0544183632
Submission date
28/09/2007
Registration date
28/09/2007
Last edited
01/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Rakesh Tandon
Scientific

Consultant Anaesthetist
Department of Anaesthetics
Box 93
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA comparison of psoas compartment and subarachnoid blocks for 'fast track' total hip arthroplasty
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Total hip arthroplasty
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Morphine
Primary outcome measureReduction in peri-operative morphine consumption
Secondary outcome measures1. Early mobility
2. Early rehabilitation
Overall study start date01/08/2006
Completion date01/08/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/08/2006
Date of final enrolment01/08/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Cambridge Consortium - Addenbrooke's (UK), Own Account NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan