Condition category
Surgery
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
01/09/2015
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 Rakesh Tandon

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes