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Trial registered on ANZCTR


Registration number
ACTRN12620000307909
Ethics application status
Approved
Date submitted
13/02/2020
Date registered
5/03/2020
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound guided hamstring block to reduce autologous graft site pain in hamstring
tendon anterior cruciate ligament reconstruction
Scientific title
Ultrasound guided Hamstrings block for autologous Graft Harvest Site Pain in Anterior
Cruciate Ligament Reconstruction: A Technical Description and Prospective Single
Blinded Randomised Control Trial
Secondary ID [1] 300543 0
Nil known
Universal Trial Number (UTN)
U1111-1248-1578
Trial acronym
SAGI-ACL
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
ACL rupture 316259 0
Pain relief 316260 0
Anaesthesia 316261 0
Condition category
Condition code
Anaesthesiology 314544 314544 0 0
Pain management
Surgery 314545 314545 0 0
Other surgery
Musculoskeletal 314546 314546 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Does the addition of ultrasound guided hamstrings block result in improved post-op analgesia compared to adductor canal block alone after autologous hamstring graft ACL reconstruction.

Patients will be given an information sheet and consent form outlining the purpose of the study, what the study involves and commonly asked questions.
Induction of anaesthesia will be performed with 1-2mcg/kg of fentanyl and propofol titrated to effect. Anaesthesia will be maintained with sevoflurane in air: oxygen to achieve an age adjusted MAC (minimum alveolar concentration) of 1.0. An Fi02 of 0.5 will be administered and ventilation managed to achieve tidal volumes of 7-10ml/kg prior to the establishment of spontaneous ventilation. Ventilation will be either spontaneous or pressure supported and fentanyl will be titrated to achieve a respiratory rate of 10-16/min. Once general anaesthesia has been established the nerve blocks will be preformed.
Intervention blocks:
o Standard Care Plus Hamstring block – in addition to adductor canal block a hamstring block will also be performed via ultrasound guidance using the same 100mm 22g Stimuplex needle to inject:
20ml 0.2% Ropivacaine (40mg Ropivacaine) with placed posterior to the belly of gracilis at the level of the adductor canal (mid-thigh)
20ml 0.2% Ropivacaine (40mg Ropivacaine) is placed either side of semitendinosus in the mid-thigh
Blocks will be performed by consultant anaesthetists or regional anaesthesia fellows under direct supervision.
Blocks will be preformed around the Saphaneous nerve in the adductor canal and hamstring fascial planes via ultrasound guidance.
Blocks wil be preformed once only after general anaesthesia has been established in the operating theatre.
Intervention code [1] 316847 0
Treatment: Drugs
Comparator / control treatment
Following informed consent for inclusion in the study, subjects will receive a standard general anaesthetic with routine monitoring. The anaesthetic regime described below would be regarded as a good standard of care for patients undergoing ACLR.

Standard Care - adductor canal block will be placed via ultrasound guidance under general anaesthesia with 20ml 0.2% ropivacaine (40mg Ropivacaine) distal to the femoral triangle and deep to sartorius muscle using a 100mm 22g Stimuplex needle.
Control group
Active

Outcomes
Primary outcome [1] 322870 0
Oral Morphine equivalent at 24H following ACL reconstruction. This will be recorded by reviewing analytics from patient-controlled analgesia machine as well as cumulative recording of opioids from the patients medication chart.
Timepoint [1] 322870 0
24 hours following surgery
Secondary outcome [1] 380079 0
Numerical pain scores via the numerical pain rating scale.
Timepoint [1] 380079 0
6 and 24 hours following surgery
Secondary outcome [2] 380080 0
Time to first opioid dose. Obtained from reviewing the first opioid dose recorded on the medication chart in PACU or the ward.
Timepoint [2] 380080 0
Following ACL reconstruction the time from arrival in PACU to the first given dose of opioid in PACU or the ward will be calculated.
Secondary outcome [3] 380081 0
Presence of post-operative nausea or vomiting - composite outcome
The presence of nausea or vomiting that requires anti emetic administration will be recorded immediately post operatively, 1 hour, 6 hour and 24 hour post operatively. PACU nurses will question patients during recovery.
Timepoint [3] 380081 0
Immediately post operatively, 1 hour, 6 hour and 24 hours post ACL reconstruction
Secondary outcome [4] 380082 0
Presence of sciatic nerve motor blockade – blockade of the motor components will be examined for by clinical examination.

o Motor blockade will be tested by power of the extensor hallucus longus, with comparison to the non-operative side. If there is a difference then motor blockade will be recorded as yes.
Timepoint [4] 380082 0
15-30 Minutes after arrival in PACU post operatively.
Secondary outcome [5] 380083 0
Quality of Recovery 15 Score
Timepoint [5] 380083 0
At 24 hours post ACL reconstruction
Secondary outcome [6] 380511 0
Presence of saphenous nerve blockade – blockade of the sensory nerve will be examined for by clinical examination. This will be tested by reduced sensation to ice on the medial malleolus of the ankle of the operative/blocked side compared to the non-operative side. If there is a difference then a sensory blockade will be recorded as yes. This will signify that an effective adductor canal block has been placed.
Timepoint [6] 380511 0
Following ACL reconstruction
Secondary outcome [7] 380744 0
Presence of sciatic nerve motor blockade – blockade of the sensory will be examined for by clinical examination.
o Sensory blockade will be tested by reduced sensation to ice on the lateral side of the foot of the operative/blocked side compared to the non-operative side. If there is a difference then sensory blockade will be recorded as yes.
Timepoint [7] 380744 0
15-30 Minutes after arrival in PACU post operatively.

Eligibility
Key inclusion criteria
Inclusion criteria
1. Patients undergoing ACL reconstruction with ipsilateral hamstrings graft
2. Age between 18 and 65
3. Operation performed under general anaesthesia
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
1. Patients having ACLR without hamstrings graft
a. ACL reconstruction using unilateral or contralateral patellar / quadriceps tendon grafts
b. ACL reconstruction using allogenic (deceased donor) grafts
c. ACL reconstruction with multi-ligament repair
2. Contralateral graft harvest site
3. Revision surgery
4. Allergy to amide local anaesthetic or its constituents
5. Allergy or contraindication to the administration of the adjuvant analgesic agents
6. Chronic pre-operative opioid use (>30mg oral morphine equivalent daily)
7. Hepatic or renal insufficiency
8. Patients unable or unwilling to give consent
9. Pregnancy
10. Spinal anaesthesia
11. Intra operative fentanyl dose greater than 4 mcg/kg
12. Pre-operative analgesia
13. Use of intraoperative nitrous oxide
14. Use of surgical instilled local anaesthetic into the hamstring donor site

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study has been designed by collaborators (both anaethetists and surgeons) in two countries who anaesthetise significant numbers of patients undergoing ACL reconstruction. Further details surrounding the literature review and study design can be found in study protocol.

Sample size has been calculated by retrospective analysis of 50 consecutive patients across two of the study sites (The Mount Hospital in Perth, Western Australia and Mercy Ascot Hospital in Auckland, New Zealand). Mean IV morphine equivalent consumption was 48.5mg during the duration of the patients hospital admission (With a standard deviation of 21.8mg).

Using alpha =0.05 with two tailed approach to statistical tests, beta = 0.3 and power 0.80 we were able to calculate that at least 40 patients in each group would be required to detect a 10mg reduction in IV morphine equivalent between the two groups.
We also have a 10% contingency included as such the overall sample size is 88 (40 +10%=44 in each group)

Demographics will be presented as number (percent) for discrete variables and median (interquartile range) for continuous variables. Tests between study group will be completed using two-tailed approaches, with p < 0.05 defined as the threshold for rejection of the null-hypothesis. Standard testing for normality (Shapiro-Wilk) will be completed to determine if parametric or non-parametric testing strategies are most appropriate for the analysis of the data in question. No interim analysis is planned.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/03/2020
Actual
Date of last participant enrolment
Anticipated
1/03/2021
Actual
Date of last data collection
Anticipated
1/04/2021
Actual
Sample size
Target
88
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 29330 0
6150 - Murdoch
Recruitment postcode(s) [2] 29331 0
6009 - Nedlands
Recruitment postcode(s) [3] 29332 0
6160 - Fremantle
Recruitment postcode(s) [4] 29333 0
6021 - Stirling
Recruitment outside Australia
Country [1] 22353 0
New Zealand
State/province [1] 22353 0
Auckland

Funding & Sponsors
Funding source category [1] 305124 0
Hospital
Name [1] 305124 0
Counties Manakau District Health Board
Country [1] 305124 0
New Zealand
Funding source category [2] 305125 0
Hospital
Name [2] 305125 0
Fiona Stanley Hospital
Country [2] 305125 0
Australia
Primary sponsor type
Individual
Name
Dr Hamish Mace
Address
Department of Anaesthesia
Fiona Stanley Hospital
11 Robin Warren Drive, Murdoch, Western Australia, 6150
Country
Australia
Secondary sponsor category [1] 305313 0
Individual
Name [1] 305313 0
Dr Nicholas Lightfoot
Address [1] 305313 0
Department of Anaesthesia and Pain Medicine
Counties Manukau Health
100 Hospital Road
Otahuhu
Auckland 2025
Country [1] 305313 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305365 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305365 0
Level 2, Education Building, Fiona Stanley Hospital 14 Barry Marshall Parade MURDOCH Western Australia 6150
Ethics committee country [1] 305365 0
Australia
Date submitted for ethics approval [1] 305365 0
Approval date [1] 305365 0
06/01/2020
Ethics approval number [1] 305365 0
RGS0000003548
Ethics committee name [2] 305366 0
Health and Disability Ethics Commitee
Ethics committee address [2] 305366 0
Ministry of Health
PO Box 5013
Wellington
6140
Ethics committee country [2] 305366 0
New Zealand
Date submitted for ethics approval [2] 305366 0
Approval date [2] 305366 0
Ethics approval number [2] 305366 0

Summary
Brief summary
Trial Objective - To determine the efficacy of the ultrasound guided “hamstrings block” in reducing pain and enhancing quality of recovery following anterior cruciate ligament reconstruction (ACLR) with a hamstring autograft.
By doing this study we hope to show that the “Hamstrings block” is effective and provide clinical evidence to support the use of this nerve block in order to optimise recovery and improve patient outcomes in the future.

Patients will be randomised to one of two groups. The first group will receive the current standard anaesthetic for ACLRs. The other group will receive the current standard anaesthetic for ACLRs plus the novel “hamstrings block”. This will be performed under general anaesthesia.

Post-operatively routine questions will be asked about pain levels and any side effects. We will briefly examine the leg to look for effects of the block by testing sensation and muscle strength. Pain levels and presence of nausea/vomiting will be recorded immediately after the operation, at 1 hour, at 6 hours and 24 hours. Also, before and after the operation we will be asking patients to complete a standardised questionnaire that will help us judge how patients have found the recovery following the operation.
We then plan to analyse the results and do a Peer reviewed publication of these results in approximately 12 months time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100130 0
Dr Hamish Mace
Address 100130 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, Perth, 6150
Country 100130 0
Australia
Phone 100130 0
+61 8 6152 2222
Fax 100130 0
Email 100130 0
[email protected]
Contact person for public queries
Name 100131 0
Hamish Mace
Address 100131 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, Perth, 6150
Country 100131 0
Australia
Phone 100131 0
+61 8 6152 2222
Fax 100131 0
Email 100131 0
[email protected]
Contact person for scientific queries
Name 100132 0
Hamish Mace
Address 100132 0
Fiona Stanley Hospital
11 Robin Warren Drive
Murdoch, Western Australia, Perth, 6150
Country 100132 0
Australia
Phone 100132 0
+61 8 6152 2222
Fax 100132 0
Email 100132 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not seek ethics approval for sharing confidential participant data to the public - HDEC ethics committee have approved our study with the understanding that we keep our data on a password protected file on our local internal server.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6903Study protocol    379268-(Uploaded-13-02-2020-14-04-35)-Study-related document.docx
6904Ethical approval    379268-(Uploaded-13-02-2020-14-05-11)-Study-related document.pdf
6905Informed consent form    379268-(Uploaded-13-02-2020-14-05-40)-Study-related document.doc



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.