Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001121651
Ethics application status
Approved
Date submitted
6/10/2014
Date registered
23/10/2014
Date last updated
25/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Post operative analgesic effect of intra-articular ropivacaine at the start and end of hip arthroscopy
Scientific title
In adult hip arthroscopy patients, does different dosage or pre-emptive timing of intra articular local anaesthetic have an effect on postoperative pain?
Secondary ID [1] 285448 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
femoro-acetabular impingement 293215 0
labral tear 293216 0
postoperative pain 293217 0
Condition category
Condition code
Musculoskeletal 293484 293484 0 0
Other muscular and skeletal disorders
Anaesthesiology 293485 293485 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be allocated into:
1) Standard Care Group: intra-articular injection of Ropivacaine 100mg at the end of hip arthroscopy
2) Treatment Group 1: intra-articular injection of Ropivacaine 200mg at the end of hip arthroscopy
3) Treatment Group 2: intra-articular injection of Ropivacaine 100mg at the beginning and end of hip arthroscopy
Intervention code [1] 290381 0
Treatment: Drugs
Comparator / control treatment
1) Standard Care Group: Ropivacaine 100mg at the end of hip arthroscopy
Control group
Active

Outcomes
Primary outcome [1] 293307 0
Pain: measured by - 1) Postoperative VAS (Visual Analogue Scale) after 0.5, 1, 2, 4, 8, 12, and 2) 24 hours, highest and lowest recovery room NRS (numerical rating scale)
Timepoint [1] 293307 0
Pain measured at: 1) Recovery time and the following time points of: 2)
0.5,1,2,4,8,12 and 24 hrs postoperative
Secondary outcome [1] 310775 0
Recovery room morphine requirements - prospective recording of mg and mg/kg intravenous morphine administered until pain score < or = 6/10
Timepoint [1] 310775 0
recovery room time
24 hourly postoperative ward
Secondary outcome [2] 310954 0
Recovery room antiemetic requirements - prospective recording of mg of ondansetron and/ or cyclizine administered until cessation of vomiting
Timepoint [2] 310954 0
Duration of stay in recovery room
Secondary outcome [3] 310955 0
24 hourly ward analgesia requirements - prospective recording of mg and mg/kg subcutaneous morphine and/ or oral oxycodone required for patient satisfaction or pain score < or =6/10
Timepoint [3] 310955 0
time from discharge to ward until 24 hours from start of surgery
Secondary outcome [4] 310956 0
24 hourly ward antiemetic requirements - prospective recording of mg of ondansetron and/ or cyclizine administered until cessation of vomiting

Timepoint [4] 310956 0
time from discharge to ward until 24 hours from start of surgery
Secondary outcome [5] 349989 0
Median Recovery room NRS-11 score
Timepoint [5] 349989 0
Duration of stay in the recovery room

Eligibility
Key inclusion criteria
All adult patients attending hip arthroscopy at Bellbird Private Hospital performed by the senior author will be eligible to participate in the study.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they had previous hip surgery, aged less than 18 or more than 75 years, diagnosis of chronic pain syndrome, contraindications to or allergic reactions to any of the standardized analgesic/ anaesthesia medication or local infiltrate components, ASA 3 or more and those requiring ketamine analgesia or regional block.

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)
The control and two intervention wings will receive the standard consent discussion as carried out by the senior author. After obtaining written consent, these patients will then be assessed for eligibility to enter the study before being randomly allocated into three different groups. Allocation concealment will be achieved by group allocation being designated to central pharmacy once eligibility is confirmed, and instructions to theatre scrub staff as to which local anaesthetic will be prepared per patient communicated by sealed envelope. Chief recruiter/ investigator and intervening surgeon will be unaware of group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random permuted block sizes of 9, 12 and 15 - to achieve balanced group sizes whilst minimizing excessive runs of single group allocations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analysis will be performed using GraphPad Prism 5 (GraphPad Software, California, USA). Continuous data will be analysed with unpaired t-tests of unequal variance. VAS data will also be treated as continuous data after confirmation of normality by histogram frequency distribution analysis and the Kolgomorov-Smirnoff normality test.

Sample size calculation was performed using G*Power 3.1 (University of Dusseldorf, Dusseldorf, Germany) statistical software. Use of 50mg of intra-articular bupivucaine results in a reduction in a mean VAS score reduction of [mean (SD)] 1cm (1.8cm) in the setting of a multimodal analgesic regime5. As the potency of 1mg bupivucaine is approximately equal to 1.5-2mg ropivacaine, the use of 200mg intra-articular ropivacaine should result in an additional VAS score reduction of 1cm, compared with the equivalent of 50mg intra-articular bupivucaine. To detect a mean difference in VAS scores of 0.3cm, the standard deviation quoted and power of 0.8, the sample size required is 150 patients. The final study sample size was terminated at 132 patients when multiple comparisons, the study's new sample Standard Deviation and Mean Differences, and the clinical significance of smaller pain scale differences were taken into account.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/11/2014
Actual
24/09/2014
Date of last participant enrolment
Anticipated
Actual
20/04/2016
Date of last data collection
Anticipated
Actual
22/04/2016
Sample size
Target
132
Accrual to date
Final
132
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11501 0
Bellbird Private Hospital - Blackburn
Recruitment postcode(s) [1] 23527 0
3130 - Blackburn

Funding & Sponsors
Funding source category [1] 290114 0
Self funded/Unfunded
Name [1] 290114 0
Country [1] 290114 0
Primary sponsor type
Individual
Name
Dr Phong Tran
Address
Specialist Orthopedic Surgery Clinic
St.Francis Building
Ground Floor, 166 Gipps St
East Melbourne
VIC 3002
Country
Australia
Secondary sponsor category [1] 288746 0
None
Name [1] 288746 0
Address [1] 288746 0
Country [1] 288746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291762 0
Melbourne Health Human Research and Ethics Committee
Ethics committee address [1] 291762 0
Ethics committee country [1] 291762 0
Date submitted for ethics approval [1] 291762 0
Approval date [1] 291762 0
10/01/2014
Ethics approval number [1] 291762 0
2013.195

Summary
Brief summary
Hip arthroscopy is a surgical procedure that gives doctors a clear view of the inside of a hip joint. Little attention has been paid to the pain management of patients undergoing hip arthroscopy. The aim of this study is to demonstrate the difference in quality of analgesia between dosage and timing of IALA (intra-articular local anaesthetic) administration in the hip joint.

150 patients undergoing hip arthroscopy by the study surgeon in a private hospital setting will be recruited in the study. Group 1 (Group R100E) will be the control group and will be administered 100mg IA Ropivacaine at the end of the procedure, as per standard practice. Group 2 (Group R200E) will be administered 200mg IA Ropivacaine at the end of the procedure. Group 3 (Group R100BE) will be administered 100mg IA Ropivacaine immediately after access is gained to the joint space, and 100mg IA Ropivacaine IA at the end of the procedure. Post-operative pain will be recorded 1) using NRS-11 score in the recovery room and (2)using a VAS scale after 0.5, 1, 2, 4, 8, 12, and 24 hours post-operatively. Patients
will receive a standardised general anaesthesia and intraoperative mulitimodal analgesia regimen. Total perioperative intravenous morphine equivalent analgesic requirements, antiemetic requiremeents, will be compared in the 24 hour postoperative period. Requirement for rescue fascia iliaca block will be recorded however the study is not powered to detect a difference in this requirement.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 51910 0
Dr Chong Oon Tan
Address 51910 0
Specialist Orthopedic Surgery Clinic
St.Francis Building
Ground Floor, 166 Gipps St
East Melbourne
VIC 3002
Country 51910 0
Australia
Phone 51910 0
+61399286161
Fax 51910 0
Email 51910 0
[email protected]
Contact person for public queries
Name 51911 0
Dr Chong Oon Tan
Address 51911 0
Specialist Orthopedic Surgery Clinic
St.Francis Building
Ground Floor, 166 Gipps St
East Melbourne
VIC 3002
Country 51911 0
Australia
Phone 51911 0
+61399286161
Fax 51911 0
Email 51911 0
[email protected]
Contact person for scientific queries
Name 51912 0
Dr Chong Oon Tan
Address 51912 0
Specialist Orthopedic Surgery Clinic
St.Francis Building
Ground Floor, 166 Gipps St
East Melbourne
VIC 3002
Country 51912 0
Australia
Phone 51912 0
+61399286161
Fax 51912 0
Email 51912 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
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