Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000827437
Ethics application status
Approved
Date submitted
19/02/2025
Date registered
1/08/2025
Date last updated
1/08/2025
Date data sharing statement initially provided
1/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Effects of Trigonum Femoral + Distal Adductor Block and Adductor Canal + N.Tibialis Posterior Block on Postoperative Pain in Total Knee Replacement Surgery: A Multicenter Study
Scientific title
Comparison of the Effects of Trigonum Femoral + Distal Adductor Block and Adductor Canal + N.Tibialis Posterior Block on Postoperative Pain in Total Knee Replacement Surgery: A Multicenter Study
Secondary ID [1] 314012 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative knee pain 336748 0
Knee replacement surgery 337948 0
Condition category
Condition code
Anaesthesiology 333238 333238 0 0
Anaesthetics
Anaesthesiology 333241 333241 0 0
Pain management
Musculoskeletal 334269 334269 0 0
Other muscular and skeletal disorders
Surgery 334270 334270 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure

The study is planned to be conducted prospectively and multicenter after approval from the Clinical Research and Ethics Committee of Kahramanmaras Sütçü Imam University Health Practice and Research Hospital.

Patients were randomly divided into 2 groups as Femoral Triangle Nerve Block + Distal Adductor Canal Block (Group A) and Adductor Canal Block + Tibialis Posterior Nerve Block (Group B) and Patient Controlled Analgesia (PCA) will be applied to both groups.
Patients' oral intake will be stopped 8 hours before surgery as we routinely do in our clinic. All of our patients will be informed about the VAS questionnaire preoperatively so that various postoperative pain treatment methods can be applied.
Patients admitted to the operating table will be monitored for heart rate, 3-lead ECG and pulse oximetry (SpO2) values, and vascular access will be established using a 20G catheter through the dorsum of the hand. While the patients are in the sitting position, aseptic conditions will be ensured and a 25 G Quincke spinal needle will be advanced through the appropriate intervertebral space (L3-L4 or L4-L5), passing through the skin, subcutaneous supraspinal ligament, interspinous ligament, ligamentum flavum, epidural space and dura to the subarachnoid space, and when it reaches the subarachnoid space, the chuck will be withdrawn and the free flow of spinal fluid will be observed. Then heavy marcain will be administered, the dose of which is determined according to the patient's height. After the level of sensory block is checked by pin prick test and motor block is checked by Bromage method, the operation will be started. In the last half hour of the operation, 100 mg tramadol+1 g paracetamol IV will be administered to the patients of both groups. At the end of the operation, patients will be taken to the operating room postoperative recovery room.
Patients in Group A will undergo Ultrasound guided Femoral Triangle Nerve + Distal Adductor technique block postoperatively by anesthesiologist (specialist) . The same volume of local anesthetic will be used in the groups, “10 mL bupivacaine 0.25%” for a single block type and “20 mL bupivacaine 0.25%” in total. After the blocks are performed, patient-controlled analgesia (PCA) will be applied to the patients from the recovery room and they will be followed up with a data monitoring form. Age, gender, body mass index, ASA scores, duration of surgery and preoperative VAS values will be recorded. IV patient-controlled analgesia with 1 mg/cc tramadol will be started in the postoperative period. The bolus dose will be 20 mg without basal infusion and the lock time will be set to 15 min. When VAS values exceed 4 in patient follow-up, 75 mg diclofenac sodium IM will be administered as rescue analgesic and recorded as additional analgesic requirement. Patients will be visited in the ward at 8, 12, and 24 hours postoperatively; the first time they used the patient-controlled pain device, the values obtained with the visual analog scale (VAS with 0-10 cm scale), and the 24-hour tramadol consumption of all patients in milligrams and the additional analgesic demand will be recorded on the postoperative follow-up forms. Patients' satisfaction levels at the end of the 24th hour will also be assessed with a four-point Likert scale (very good, good, fair, and poor) and quality of recovery will be assessed with the QOR-15 questionnaire.
Intervention code [1] 330592 0
Other interventions
Comparator / control treatment
Patients will be randomized as Group A and Group B by closed envelope procedure. Patients in Group A will undergo USG guided Femoral Triangle Nerve + Distal Adductor technique block. Patients in Group B will receive Adductor canal + N.Tibialis posterior block under USG guidance. The same volume of local anesthetic will be used in the groups, “10 mL bupivacaine 0.25%” for a single block type and “20 mL bupivacaine 0.25%” in total. The same postoperative nerve block will be administered to group B by an anaesthesiologist with the aid of ultrasound. After the blocks are performed, patient-controlled analgesia (PCA) will be applied to the patients from the recovery room and they will be followed up with a data monitoring form. Age, gender, body mass index, ASA scores, duration of surgery and preoperative VAS values will be recorded. IV patient-controlled analgesia with 1 mg/cc tramadol will be started in the postoperative period. The bolus dose will be 20 mg without basal infusion and the lock time will be set to 15 min. When VAS values exceed 4 in patient follow-up, 75 mg diclofenac sodium IM will be administered as rescue analgesic and recorded as additional analgesic requirement. Patients will be visited in the ward at 8, 12, and 24 hours postoperatively; the first time they used the patient-controlled pain device, the values obtained with the visual analog scale (VAS with 0-10 cm scale), and the 24-hour tramadol consumption of all patients in milligrams and the additional analgesic demand will be recorded on the postoperative follow-up forms. Patients' satisfaction levels at the end of the 24th hour will also be assessed with a four-point Likert scale (very good, good, fair, and poor) and quality of recovery will be assessed with the QOR-15 questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 340806 0
Postoperative Pain Scores
Timepoint [1] 340806 0
Participant pain levels will also be assessed at 8, 12, and 24 hours postoperatively.
Secondary outcome [1] 445112 0
Postoperative Analgesic Consumption
Timepoint [1] 445112 0
Participant consumptions will also be assessed at 8, 12, and 24 hours postoperatively.

Eligibility
Key inclusion criteria
1. Patients between 18-80 years of age who will undergo knee prosthesis surgery
2. ASA I-III patients
3. Patients with full orientation-cooperation and communication
4. Patients whose surgery was completed under spinal anesthesia
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients allergic to local anesthetics and/or drugs used in the study
2. Patients whose patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively
3. Patients with peripheral neuropathy or neuromuscular disease
4. Patients with anticoagulant drug use and bleeding profile disorders that would prevent regional anesthesia

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be randomized into Group A and Group B using the closed envelope method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be randomized into Group A and Group B using the closed envelope method.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/04/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
60
Accrual to date
30
Final
Recruitment outside Australia
Country [1] 26906 0
Turkey
State/province [1] 26906 0
IZMIR

Funding & Sponsors
Funding source category [1] 318517 0
Self funded/Unfunded
Name [1] 318517 0
Country [1] 318517 0
Primary sponsor type
University
Name
ege university
Address
Country
Turkey
Secondary sponsor category [1] 320909 0
None
Name [1] 320909 0
Address [1] 320909 0
Country [1] 320909 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317122 0
Kahramanmaras Sütçü Imam University Faculty of Medicine CLINICAL RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 317122 0
Ethics committee country [1] 317122 0
Turkey
Date submitted for ethics approval [1] 317122 0
19/12/2022
Approval date [1] 317122 0
01/02/2023
Ethics approval number [1] 317122 0

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

Contacts
Principal investigator
Name 140070 0
Ms Nezih Sertoz
Address 140070 0
ege university agacli yol street bornova Izmir postcode:35010
Country 140070 0
Turkey
Phone 140070 0
+905326217119
Fax 140070 0
Email 140070 0
[email protected]
Contact person for public queries
Name 140071 0
Kazim Koray Ozgul
Address 140071 0
ege university ege university agacli yol street bornova Izmir postcode:35010
Country 140071 0
Turkey
Phone 140071 0
+905066992303
Fax 140071 0
Email 140071 0
[email protected]
Contact person for scientific queries
Name 140072 0
Nezih Sertoz
Address 140072 0
ege university ege university agacli yol street bornova Izmir postcode:35010
Country 140072 0
Turkey
Phone 140072 0
+905326217119
Fax 140072 0
Email 140072 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.