Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001309673p
Ethics application status
Submitted, not yet approved
Date submitted
24/11/2023
Date registered
15/12/2023
Date last updated
15/12/2023
Date data sharing statement initially provided
15/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The Utility of Pericapsular Nerve Group (PENG) Block versus Intrathecal Morphine for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Multicentre Triple Blinded Randomised Controlled Trial
Scientific title
The Utility of Pericapsular Nerve Group (PENG) Block versus Intrathecal Morphine for Postoperative Analgesia in Anterior Approach Total Hip Arthroplasty: A Multicentre Triple Blinded Randomised Controlled Trial
Secondary ID [1] 310718 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip Arthroplasty 331654 0
Pain Management 331655 0
Condition category
Condition code
Anaesthesiology 328374 328374 0 0
Pain management
Musculoskeletal 329001 329001 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
PENG Group: The block will be placed using ultrasound guidance with a curvilinear probe (2.5-5 MHz). 20 mL of ropivacaine 0.5% (100 mg) prepared by the anaesthesiologist performing the block will be used. The area is aseptically prepped and draped. The curvilinear probe will be placed transversely, medial to the anterior inferior iliac spine with the medial end of the probe rotated in a caudad direction to align to the superior pubic ramus. A 100 mm Sonoplex needle will be inserted in-plane under ultrasound guidance. 20 mLs of local anaesthetic (ropivacaine) will be injected as a plane block between the psoas fascia and superior pubic rami. A cross shall then be drawn on the skin with surgical marker to disguise the presence of a puncture site.

Adherence will be monitored by auditing of anaesthesia records
Intervention code [1] 327116 0
Treatment: Drugs
Comparator / control treatment
Intrathecal Morphine Group: In addition to the spinal anaesthesia already infiltrated, a further 100 mcg of morphine will be administered. The sham block will be then simulated by the anaesthesiologist by prepping, scanning, and draping as per PENG block protocol. The probe and a blunt needle, with a 20 mL syringe filled with saline attached, were held against the skin, similar to the PENG block, and a sufficient pause to simulate the block being performed will be conducted, without penetration of skin or actual administration of any medicine. Likewise, a cross shall then be drawn on the skin with surgical marker to disguise the absence of a puncture site.
Control group
Active

Outcomes
Primary outcome [1] 336215 0
Dynamic pain score
Timepoint [1] 336215 0
3 and 24 hours postoperatively
Secondary outcome [1] 427374 0
Quadriceps Muscle Strength
Timepoint [1] 427374 0
Preoperative, 3 hours and 24 hours postoperatively
Secondary outcome [2] 427375 0
Sedation
Timepoint [2] 427375 0
Preoperative, 3 hours and 24 hours postoperatively
Secondary outcome [3] 427376 0
Postoperative nausea and vomiting (composite)
Timepoint [3] 427376 0
Preoperative, 3 hours and 24 hours postoperatively
Secondary outcome [4] 429237 0
Postoperative Antiemetic Use
Timepoint [4] 429237 0
First 24 hours after surgery and 24 – 48 hours after surgery
Secondary outcome [5] 429238 0
Pruritus
Timepoint [5] 429238 0
Preoperative, 3 hours and 24 hours postoperatively
Secondary outcome [6] 429239 0
Postoperative Antihistamine Use
Timepoint [6] 429239 0
First 24 hours after surgery and 24 – 48 hours after surgery
Secondary outcome [7] 429240 0
Postoperative opioid use
Timepoint [7] 429240 0
First 24 hours after surgery and 24 – 48 hours after surgery
Secondary outcome [8] 429241 0
Postoperative complications
Timepoint [8] 429241 0
Assessed daily throughout the postoperative period until discharge from hospital
Secondary outcome [9] 429242 0
Time to mobilisation
Timepoint [9] 429242 0
After discharge from hospital
Secondary outcome [10] 429243 0
Length of Stay
Timepoint [10] 429243 0
After discharge from hospital
Secondary outcome [11] 429244 0
Quality of Life Score
Timepoint [11] 429244 0
24 hours postoperatively
Secondary outcome [12] 429245 0
Patient satisfaction
Timepoint [12] 429245 0
24 hours postoperatively
Secondary outcome [13] 429682 0
Quality of Recovery
Timepoint [13] 429682 0
24 hours postoperatively

Eligibility
Key inclusion criteria
All adult patients above the age of 18 years old presenting for primary elective anterior approach Total Hip Arthroplasty (THA) under spinal anaesthesia will be invited to participate in our study. Included participants must be able to provide informed consent and reliably report symptoms to the research team.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude patients who are (1) unable to provide first party consent (e.g., due to cognitive impairment or language barrier), (2) procedure not performed via an anterior approach, (3) contraindications for any of the following: spinal, intrathecal morphine or PENG block (e.g. therapeutic anticoagulation, anaphylaxis to local anaesthetics or morphine), (4) patient refusal of spinal anaesthesia and/or regional analgesia, and (5) clinical indications for general anaesthesia rather than spinal anaesthesia.

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)
Computer generated random treatment assignment (sealedenvelope.com) on a 1:1 ratio with permutated blocks (randomly generated blocks of 2, 4 and 6) will be performed immediately prior to surgery by the anaesthetist. Allocation concealment will be maintained via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random treatment assignment (sealedenvelope.com) on a 1:1 ratio with permutated blocks (randomly generated blocks of 2, 4 and 6)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses will be performed using Stata Version 18 (StataCorp, USA). The threshold for statistical significance in this study is set at 95%. As two primary outcomes are measured, a corrected p-value threshold of 0.025, obtained using the Bonferroni correction technique will be utilised when assessing these outcomes. Intention to treat analysis will be performed in all cases. Categorical variables will be displayed as frequency (percentage) and analysed using chi-squared test. Continuous variables will be assessed for normality using the Shapiro-Wilk test. Normally distributed data will be displayed as mean ± standard deviation and analysed using unpaired t-test. Continuous data that is not normally distributed will be displayed as median (range) and analysed using Mann-Whitney U test. Nonadherence to randomly assigned treatment may mean that the intention to treat analysis may misrepresent the true treatment effect. Therefore, a per-protocol analysis will be performed if there is greater than 10% crossover between groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 314934 0
Charities/Societies/Foundations
Name [1] 314934 0
Australian Society of Anaethetists
Country [1] 314934 0
Australia
Primary sponsor type
Individual
Name
Tim Cheok
Address
College of Medicine and Public Health, Flinders University, Sturt Road, Bedford Park, Adelaide, South Australia 5042, Australia
Country
Australia
Secondary sponsor category [1] 316939 0
Individual
Name [1] 316939 0
Ruurd Jaarsma
Address [1] 316939 0
Department of Orthopaedic Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park, Adelaide, South Australia 5042, Australia
Country [1] 316939 0
Australia
Secondary sponsor category [2] 316940 0
Individual
Name [2] 316940 0
D-Yin Lin
Address [2] 316940 0
Department of Anaesthetics, Flinders Medical Centre, Flinders Drive, Bedford Park, Adelaide, South Australia 5042, Australia
Country [2] 316940 0
Australia
Other collaborator category [1] 282879 0
Individual
Name [1] 282879 0
Brigid Brown
Address [1] 282879 0
Department of Anaesthetics, Flinders Medical Centre, Flinders Drive, Bedford Park, Adelaide, South Australia 5042, Australia
Country [1] 282879 0
Australia
Other collaborator category [2] 282880 0
Individual
Name [2] 282880 0
Thomas Smith
Address [2] 282880 0
College of Medicine and Public Health, Flinders University, Sturt Road, Bedford Park, South Australia 5042, Australia
Country [2] 282880 0
Australia
Other collaborator category [3] 282881 0
Individual
Name [3] 282881 0
Craig Morrison
Address [3] 282881 0
Department of Anaesthetics, Flinders Medical Centre, Flinders Drive, Bedford Park, Adelaide, South Australia 5042, Australia
Country [3] 282881 0
Australia
Other collaborator category [4] 282882 0
Individual
Name [4] 282882 0
Job Doornberg
Address [4] 282882 0
Department of Orthopaedic Surgery, University Medical Center Groningen, PO Box 30.001, 9700 RB Groningen, The Netherlands
Country [4] 282882 0
Netherlands
Other collaborator category [5] 282883 0
Individual
Name [5] 282883 0
Hidde Kroon
Address [5] 282883 0
College of Medicine and Public Health, Flinders University, Sturt Road, Bedford Park, Adelaide, South Australia 5042, Australia
Country [5] 282883 0
Australia
Other collaborator category [6] 282884 0
Individual
Name [6] 282884 0
Ki Jinn Chin
Address [6] 282884 0
Department of Anaesthesiology and Pain Medicine, Toronto Western Hospital, 399 Bathurst Street, McL 2-405 Toronto ON M5T 2S8
Country [6] 282884 0
Canada

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314207 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 314207 0
Ethics committee country [1] 314207 0
Australia
Date submitted for ethics approval [1] 314207 0
24/11/2023
Approval date [1] 314207 0
Ethics approval number [1] 314207 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129810 0
Dr Tim Cheok
Address 129810 0
Department of Orthopaedic Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 South Australia
Country 129810 0
Australia
Phone 129810 0
+61 427666324
Fax 129810 0
Email 129810 0
[email protected]
Contact person for public queries
Name 129811 0
Tim Cheok
Address 129811 0
Department of Orthopaedic Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 South Australia
Country 129811 0
Australia
Phone 129811 0
+61 427666324
Fax 129811 0
Email 129811 0
[email protected]
Contact person for scientific queries
Name 129812 0
Tim Cheok
Address 129812 0
Department of Orthopaedic Surgery, Flinders Medical Centre, Flinders Drive, Bedford Park 5042 South Australia
Country 129812 0
Australia
Phone 129812 0
+61 427666324
Fax 129812 0
Email 129812 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


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.