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Trial registered on ANZCTR


Registration number
ACTRN12618001771246
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
29/10/2018
Date last updated
27/09/2021
Date data sharing statement initially provided
29/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Analgesia post Total Knee Replacement surgery - Comparision between Local Infiltration Analgesia and Ultrasound Guided Single Shot Adductor Canal Block.
Scientific title
Comparison between Local Infiltration Analgesia and Ultrasound Guided Single Shot Adductor Canal Block post Total Knee Replacement Surgery.
Secondary ID [1] 296274 0
None
Universal Trial Number (UTN)
U1111-1222-4179
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative Pain in Patients undergoing Total Knee Replacement Surgery 310072 0
Condition category
Condition code
Anaesthesiology 308824 308824 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Title of the Study
Comparison between Local Infiltration Analgesia (LIA) and Ultrasound Guided Single Shot Adductor Canal Block (UG-SS-ACB) for post-operative pain relief in patients undergoing Total Knee Replacement surgery.


Methods:
All 60 patients enrolled for the study will receive spinal anesthesia with 0.5% bupivacaine heavy 2.8 ml with Fentanyl 20 microgram(Total volume = 3.2 ml), prior to surgery. The spinal Anesthetic will be administered in the Operation Theater (as it is the Hospital protocol). The patient will be wheeled to the operation theater and standard monitoring i.e. Electrocardiography(ECG), Pulse oximetry and Noninvasive blood pressure. After completion of the WHO surgical safety checklist and “Sign - in”, the patient will be placed in a sitting position. After proper aseptic procedures including painting the lower back with Betadine solution, a local anesthetic solution containing 1% Lidocaine 2mls will be injected in L3 - L4 interspace. Dural Puncture will be performed with 25 G Pencil Point needle, and after confirming free flow of Cerebrospinal Fluid, 3.2 ml of above-mentioned solution will be injected. There Patient will be placed in a supine position and the table tilt will be adjusted to achieve a block height between T12 and T8 sensory level. After confirming a minimum of T12 sensory level the surgical team will be allowed to clean and sterilize the limb and proceed to start the surgery. The approximate time of start of surgery from the time of spinal anesthetic in our routine cases is 30 minutes.


Group A patients will be given local infiltration analgesia at the end of surgery which will be injected at the posterior capsule (40 ml), anterior capsule (40 ml), patellar tendon (25 ml), quadriceps tendon(25 ml) and subcutaneous tissue at incision line(20 ml). The local infiltration analgesia will be prepared using a mixture of 50 ml of 0.25% bupivacaine, 10mg morphine [1ml] and 99 ml normal saline to make a volume of 150 ml.

Group B patients will be given adductor canal block under ultrasound guidance with 25 ml 0.5% bupivacaine at the mid-thigh level at the end of surgery.

Postoperatively all patients will be given Patient Controlled Analgesia(PCA) morphine 1mg bolus with a lockout of 5 minutes, the 4 hourly limits being 30 mg. In addition, all patients will receive oral paracetamol 1g every 6 Hourly and diclofenac 50mg every 8 hourly, for 24 hours starting from the end of the surgery.

The Pain management team, which consists of dedicated pain management nurses, will be notified to follow the patient and collect the data at the end of 24 hours. The pain management team will be blinded to the intervention the patient received. This team will follow up with the patient at 24 hours and collect and record the data on the data collection sheet(attached in the section of documents).
Intervention code [1] 312681 0
Treatment: Other
Comparator / control treatment
Group A - Local Infiltration Analgesia
Control group
Active

Outcomes
Primary outcome [1] 307800 0
Quantitative assessment of Postoperative Pain relief by evaluating first 24 hours morphine consumption.
The log of the PCA(Patient Controlled Analgesia) Pump is retrieved by the nurse at 24 hours after the surgery and the total morphine consumption is noted on the Chart in numerics.
Timepoint [1] 307800 0
0-24 Hours Post Operatively (zero time is the time of the end of surgery).
The morphine consumption is noted at following time points. 1st dose of morphine demand, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
Primary outcome [2] 307897 0
Pain scores.
Pain scores at rest and flexion of the operated knee at 4, 6, 8, 12, 24 hours post-surgery.
A Visual Analogue Scale (VAS) is marked at one end with '0'(zero) denoting no pain and 10 denoting the worst Pain the Patient can imagine, on the other end,
The patient will be explained about the use of this scale and asked to point to a point on the scale which would describe the appropriate amount of pain he/she perceives. This will be recorded on the data collection chart in numerics.
Timepoint [2] 307897 0
0 to 24 hours after the end of surgery.
Pain scores are recorded on a chart at time zero (end of surgery), 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
Secondary outcome [1] 352956 0
Sedation scores
Sedation scores will be assessed using the Pasero opioid-induced sedation scale [POSS].
Timepoint [1] 352956 0
0 to 24 hours after the end of surgery.
This is a composite secondary outcome and will note the sedation scores in the first 24 hours post-surgery at specific time points
Sedation scores are recorded on a chart at time zero (end of surgery), 4 hours, 6 hours, 8 hours, 12 hours and 24 hours after the end of surgery.
Secondary outcome [2] 352957 0
Incidence of nausea/ vomiting.
This will be noted as a Yes/NO in appropriate boxes on the observation chart.
This is a composite secondary outcome which will note the occurrence of nausea and/or vomiting in the first 24 hours post surgery and note the time of its occurrence.
Timepoint [2] 352957 0
0 to 24 hours after the end of surgery.
The incidence of Nausea and/or vomiting will be recorded in appropriate boxes on the observation chart.
Secondary outcome [3] 352958 0
Patient satisfaction
Overall patient satisfaction scores with respect to pain relief will be assessed at the end of 24 hours’ post-op on a five-point Likert scale.
Timepoint [3] 352958 0
24 hours after the end of surgery

Eligibility
Key inclusion criteria
• Adults patients (18-75 years)
• Admitted for Total knee replacement
• ASA 1 to 3 patients
• Patients receiving spinal anesthesia for surgery
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients with contraindication to spinal anesthesia/ nerve block
• Patients with allergy to local anesthetics, morphine. Paracetamol and non- steroidal anti-inflammatory drugs
• Patients on regular opioid use
• ASA 4 patients
• Patient refusal

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 phone/fax/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 (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2018
Actual
1/11/2018
Date of last participant enrolment
Anticipated
31/10/2019
Actual
5/11/2019
Date of last data collection
Anticipated
1/11/2019
Actual
6/11/2019
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 20936 0
Bahrain
State/province [1] 20936 0

Funding & Sponsors
Funding source category [1] 300867 0
Hospital
Name [1] 300867 0
King Hamad University Hospital
Country [1] 300867 0
Bahrain
Primary sponsor type
Hospital
Name
King Hamad University Hospital
Address
Building 2435, Road 2835, Block 228, Busaiteen, P.O. Box 24343, Bahrain
Country
Bahrain
Secondary sponsor category [1] 300543 0
None
Name [1] 300543 0
Address [1] 300543 0
Country [1] 300543 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301642 0
Research and Ethics, King Hamad University Hospital, Bahrain
Ethics committee address [1] 301642 0
Ethics committee country [1] 301642 0
Bahrain
Date submitted for ethics approval [1] 301642 0
Approval date [1] 301642 0
17/09/2018
Ethics approval number [1] 301642 0
Ref. KHUH/Research/No.237/2018

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

Contacts
Principal investigator
Name 87638 0
Dr Priti Narayan
Address 87638 0
Consultant, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country 87638 0
Bahrain
Phone 87638 0
+97333008381
Fax 87638 0
Email 87638 0
priti.narayan@khuh.org.bh
Contact person for public queries
Name 87639 0
Vijay Sahitya
Address 87639 0
Registrar, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country 87639 0
Bahrain
Phone 87639 0
+97335388245
Fax 87639 0
Email 87639 0
vijay.sahitya@khuh.org.bh
Contact person for scientific queries
Name 87640 0
Priti Narayan
Address 87640 0
Consultant, Department Of Anesthesia and Pain Management.
King Hamad University Hospital, Building 2345, Road 2835, Block 228, Busaiteen, P. O. Box 24343, Kingdom of Bahrain
Country 87640 0
Bahrain
Phone 87640 0
+97333008381
Fax 87640 0
Email 87640 0
priti.narayan@khuh.org.bh

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a new requirement, made mandatory from today i.e. 25/10/2018. The registration for this trial was started earlier and was in the review process. Furthermore, The study proposal was made and approval for it was secured from the hospitals Research and Ethics committee on 17/09/2018 without this requirement. Hence in view of all these factors, at this stage, we cannot assure what IPD we would be able to make available.


What supporting documents are/will be available?




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.