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Trial registered on ANZCTR


Registration number
ACTRN12609000316202
Ethics application status
Approved
Date submitted
29/03/2009
Date registered
21/05/2009
Date last updated
3/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pain Relief after Hip Replacement Surgery: A comparison of two approaches
Scientific title
Optimising Pain Relief after Hip Replacement Surgery: A comparison of Patient Controlled Lumbar Plexus Block and Patient Controlled Iintravenous (IV) Opioid Analgesia
Secondary ID [1] 259925 0
THJR09
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief after hip replacement surgery 4532 0
Condition category
Condition code
Anaesthesiology 4820 4820 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient controlled continuous lumbar plexus block (ropivacaine 0.2% 5 ml/hr with as required 5 ml boluses via a catheter inserted near the lumbar plexus) during the first 48 postoperative hours after hip replacement surgery
Intervention code [1] 4291 0
Treatment: Drugs
Comparator / control treatment
Subarachnoid block (bupivacaine 0.5% 2.5 mL) with Patient controlled intravenous opioid (morphine) analgesia during the first 48 postoperative hours after hip replacement surgery
Control group
Active

Outcomes
Primary outcome [1] 5680 0
Pain after hip replacement surgery, assessed by patient interrogation regarding analgesic consumption pain scores using numerical rating pain score (NRPS).
Timepoint [1] 5680 0
1-2 days postoperatively. Analgesic requirements and pain scores measured in the afternoon of Day 1 and Day 2 following surgery.
Secondary outcome [1] 241579 0
Postoperative antiemetic consumption
Timepoint [1] 241579 0
First 48 postoperative hours every 24 hours.
Secondary outcome [2] 241979 0
Procedural time
Timepoint [2] 241979 0
At time of procedure
Secondary outcome [3] 241980 0
Patient physiotherapy endpoints:
Bed-to-chair: yes/no
Bed-to-bathroom: yes/no
Walk > 12 metres: yes/no
Timepoint [3] 241980 0
Daily for first 2 days

Eligibility
Key inclusion criteria
Patients requiring analgesia following hip replacement surgery under the care of the three investigators
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal of either block. 2. Known neuropathy involving the leg undergoing surgery. 3. Known allergy to amide local anaesthetic drugs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Initial invitation to participate in the study will occur in the surgeon's rooms. Approximately one week prior to surgery, patients will be contacted by a research assistant to provide further informed consent. Written informed consent will be obtained from all patients.
Assignment of the patient to lumbar plexus block or IV opioid analgesia will be delivered in a sealed opaque envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be used to assign the patient to one of the 2 groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1700 0
New Zealand
State/province [1] 1700 0
Auckland

Funding & Sponsors
Funding source category [1] 4722 0
Charities/Societies/Foundations
Name [1] 4722 0
Auckland Medical Research Foundation
Address [1] 4722 0
P O Box 110139 Auckland Hospital Auckland 1148
Country [1] 4722 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute,
P O Box 109 199,
Newmarket,
Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 4267 0
None
Name [1] 4267 0
Address [1] 4267 0
Country [1] 4267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6765 0
Northern Y Regional Ethics Committee
Ethics committee address [1] 6765 0
P O Box 1031,
Hamilton,
Waikato Mail Centre 3240
Ethics committee country [1] 6765 0
New Zealand
Date submitted for ethics approval [1] 6765 0
05/03/2009
Approval date [1] 6765 0
21/05/2009
Ethics approval number [1] 6765 0
NTY/09/03/029

Summary
Brief summary
If the primary hypothesis is confirmed, this study will provide evidence supporting the Patient Controlled Lumbar Plexus Block for postoperative analgesia for total hip replacement surgery. Increased exposure of the techniques may promote their uptake in this setting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29440 0
Dr Michael Fredrickson
Address 29440 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1050
Country 29440 0
New Zealand
Phone 29440 0
+645221117
Fax 29440 0
Email 29440 0
michaelfredrickson@yahoo.com
Contact person for public queries
Name 12687 0
Dr Dr Michael Fredrickson
Address 12687 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 12687 0
New Zealand
Phone 12687 0
+64 9 522 1117
Fax 12687 0
+64 9 522 1127
Email 12687 0
anaesthesiainstitute@yahoo.com
Contact person for scientific queries
Name 3615 0
Dr Dr Michael Fredrickson
Address 3615 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 3615 0
New Zealand
Phone 3615 0
+64 9 522 1117
Fax 3615 0
+64 9 522 1127
Email 3615 0
michaelfredrickson@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary