Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000714987
Ethics application status
Not yet submitted
Date submitted
14/06/2011
Date registered
11/07/2011
Date last updated
11/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A trial determining whether injections of local anaesthetic in front and behind the hip can make arthroscopic hip surgery less painful
Scientific title
In patients having arthroscopic hip surgery are ultrasound guided anterior and posterior pericapsular injections of local anaesthetic as good as or better than injections of saline alone for relief of pain following surgery
Secondary ID [1] 262383 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain reduction following athroscopic hip surgery 268072 0
Condition category
Condition code
Anaesthesiology 268217 268217 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound guided injection of single 10ml ropivacaine 0.75% dose, both anteriorly and posteriorly, into the potential space superficial to hip capsule, immediately prior to surgery.
Intervention code [1] 266761 0
Treatment: Drugs
Comparator / control treatment
Ultrasound guided injection of saline into the potential space superficial to both the anterior and the posterior hip capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 268958 0
Reduction in postoperative pain scores measured with a 10cm visual analogue scale, with 0 being no pain ,and 10 being the worst pain imaginable
Timepoint [1] 268958 0
On emergence from anaesthesia, and at 1, 2, 6 and 24 hours postoperatively
Secondary outcome [1] 276693 0
Dose of postoperative morphine required to control postopertive pain
Timepoint [1] 276693 0
On emergence from anaesthesia, and at 1, 2, 6 and 24 hours postoperatively

Eligibility
Key inclusion criteria
Patient’s requiring elective unilateral arthroscopic hip surgery under the anaesthetic care of the principal investigator and the co-investigators.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient refusal
2. Any communicative problem due to deafness or cognitive impairment
3. Allergy to amide local anaesthetic drugs
4. Chronic opioid usage
5. Patient intolerant of all NSAID drugs
6. Infection at site of needle puncture

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)
A research assitant will determine suitable candidtaes from a surgical list. Patients would then be contacted by phione and sent study material by mail or electronically.

Consenting patients will be randomised in equal numbers to either the pericapsular local anaesthetic or the pericapsular saline groups. Randomization will result in a set of sealed randomization envelopes. Each successive patient will be assigned a unique identification number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be generated by computer. The sequence will include stratification for center and will be arranged within permuted blocks. The statistician will maintain a confidential schedule of patient numbers and procedure allocation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3627 0
New Zealand
State/province [1] 3627 0

Funding & Sponsors
Funding source category [1] 267244 0
Self funded/Unfunded
Name [1] 267244 0
N/A
Country [1] 267244 0
Primary sponsor type
University
Name
University of Auckland
Address
Private Bag 92019
Wellesley St
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 266309 0
Hospital
Name [1] 266309 0
Waitemata District Health Board
Address [1] 266309 0
Shakespeare Rd
Milford
Auckland 0740
Country [1] 266309 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269235 0
Northern X Ethics Committee
Ethics committee address [1] 269235 0
Postal address:
Private Bag 92-522
Wellesley St
Auckland 1010

Courier address:
3rd floor, Unisys building
650 Great South Rd
Penrose
Auckland 1061
Ethics committee country [1] 269235 0
New Zealand
Date submitted for ethics approval [1] 269235 0
01/07/2011
Approval date [1] 269235 0
Ethics approval number [1] 269235 0

Summary
Brief summary
Many patients find hip arthroscopy surgery to be very painful in the first few hours following the operation. We think this may be due to the swelling of the hip joint capsule that occurs during this type of surgery. The purpose of this study is to determine whether injecting local anaesthetic medication on both the front and the back of the hip joint, at the start of the operation, will make this surgery less painful.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32739 0
Address 32739 0
Country 32739 0
Phone 32739 0
Fax 32739 0
Email 32739 0
Contact person for public queries
Name 15986 0
Darcy Price
Address 15986 0
Department of Anaesthesia
North Shore Hospital
Shakespeare Rd
Milford
Auckland 0740
Country 15986 0
New Zealand
Phone 15986 0
64 9 4418991
Fax 15986 0
Email 15986 0
[email protected]
Contact person for scientific queries
Name 6914 0
Darcy Price
Address 6914 0
Department of Anaesthesia
North Shore Hospital
Shakespeare Rd
Milford
Auckland 0740
Country 6914 0
New Zealand
Phone 6914 0
64 9 4418991
Fax 6914 0
Email 6914 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.