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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203483
Other study ID # Bursa City Hospital 6
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2024
Est. completion date June 10, 2024

Study information

Verified date April 2024
Source Bursa City Hospital
Contact Mursel Ekinci
Phone +905067137596
Email drmurselekinci@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Knee arthroplasty surgery numbers are increasing depending on joint deformities and cartilage degenerations. Severe postoperative pain may occur in these patients due to surgery and the placed prosthesis. The aim of study is to compare the effectiveness of AKB and PENG block for postoperative analgesia management after knee arthroplasty.


Description:

Knee arthroplasty surgery numbers are increasing depending on joint deformities and cartilage degenerations. Severe postoperative pain may occur in these patients due to surgery and the placed prosthesis. Postoperative analgesia is important for early mobilization. So that, early movement of the joint is ensured and complications such as thromboembolism and infection are prevented. Various methods can be used for postoperative analgesia. One of these methods is epidural analgesia. However, it may not be applied due to the patient's refusal or the technical difficulties in the application. Another option is opioid agents. However; opioids have side effects such as nausea, vomiting, sedation, respiratory depression. Femoral nerve blockade can be done, but it is not preferred because it may prevent mobilization as a result of motor blockade. Current regional anesthesia techniques used in knee surgery include selective blockade of the saphenous nerve in the adductor canal (adductor canal block-ACB) and pericapsular nerve group block (PENG). Adductor canal block; affects the vastus medialis branch of the saphenous nerve, one of the two largest sensory nerves from the femoral nerve to the knee, and the articular branches of the obturator nerve. Since the block is made in the distal thigh, the innervation of the quadriceps muscle is not affected, and therefore the motor power of this muscle is largely preserved. Another lower extremity peripheral regional blockade technique that is gaining importance today is PENG block. PENG, which is a musculofacial plane block made between the tendon of the psoas muscle and the ramus pubis, provides block of the femoral nerve, obturator nerve and accessory obturator nerve. In both block methods, pure sensory blockade provides analgesia without quadriceps muscle weakness, and this provides a significant advantage in terms of early mobilization. The aim of this study is to compare these two analgesic methods in terms of effectiveness for postoperative analgesia management after knee arthroplasty. The primary outcome is to compare global recovery scores (QoR-15 scale), the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative opioid consumption, postoperative rescue analgesic (opioid) use, presence of motor blockade, postoperative first mobilization time, and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 10, 2024
Est. primary completion date March 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - American Society of Anesthesiologists (ASA) classification I-II - Scheduled for total knee arthroplasty under spinal anesthesia Exclusion Criteria: - history of bleeding diathesis - receiving anticoagulant treatment, - known local anesthetics and opioid allergy, - infection of the skin at the site of the needle puncture, - pregnancy or lactation, - patients who do not accept the procedur

Study Design


Intervention

Drug:
Adductor canal block
A linear ultrasound probe will be placed medial to the patella, the probe will be advanced to cephalad, and the superficial femoral artery will be visualized. The block site will be confirmed by injecting 5 ml of saline around the saphenous nerve in the subsartorial region under ultrasound guidance. Then, 30 ml of local anesthetic solution containing 0.25% bupivacaine (Marcain 0.5% AstraZeneca, England) will be administered.
PENG block
The probe will be placed at the anterior superior level of spina iliaca, parallel to the inguinal ligament. The probe will be scanned gradually towards the caudal. After the anterior inferior of the spina iliaca is visible, the probe will be slightly turned medially until the hyperechoic shadow of the superior pubic ramus is visible. The psoas muscle tendon will be visualized above the superior pubic ramus, then 5 ml of saline will be injected under the psoas tendon and the block location will be confirmed. After that 30 ml of 0.25% bupivacaine will be administered.

Locations

Country Name City State
Turkey Mürsel Ekinci Bursa

Sponsors (1)

Lead Sponsor Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Jiang X, Wang QQ, Wu CA, Tian W. Analgesic Efficacy of Adductor Canal Block in Total Knee Arthroplasty: A Meta-analysis and Systematic Review. Orthop Surg. 2016 Aug;8(3):294-300. doi: 10.1111/os.12268. — View Citation

Kapoor R, Adhikary SD, Siefring C, McQuillan PM. The saphenous nerve and its relationship to the nerve to the vastus medialis in and around the adductor canal: an anatomical study. Acta Anaesthesiol Scand. 2012 Mar;56(3):365-7. doi: 10.1111/j.1399-6576.2011.02645.x. — View Citation

Kim S, Bosque J, Meehan JP, Jamali A, Marder R. Increase in outpatient knee arthroscopy in the United States: a comparison of National Surveys of Ambulatory Surgery, 1996 and 2006. J Bone Joint Surg Am. 2011 Jun 1;93(11):994-1000. doi: 10.2106/JBJS.I.01618. — View Citation

Manickam B, Perlas A, Duggan E, Brull R, Chan VW, Ramlogan R. Feasibility and efficacy of ultrasound-guided block of the saphenous nerve in the adductor canal. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):578-80. doi: 10.1097/aap.0b013e3181bfbf84. — View Citation

Sahoo RK, Jadon A, Sharma SK, Nair AS. Pericapsular nerve group (PENG) block for hip fractures: Another weapon in the armamentarium of anesthesiologists. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):295-296. doi: 10.4103/joacp.JOACP_295_20. Epub 2021 Jul 15. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Global recovery scoring system (patient satisfaction scale) The investigators will use the Turkish version of Quality of Recovery / QoR-15 questionairre
PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])
Able to breathe easily
Been able to enjoy food
Feeling rested
Have had a good sleep
Able to look after personal toilet and hygiene unaided
Able to communicate with
Getting support from hospital doctors and nurses
Able to return to work or usual home activities
Feeling comfortable and in control
Having a feeling of general well-being
PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor])
Moderate pain
Severe pain
Nausea or vomiting
Feeling worried or anxious
Feeling sad or depressed
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
Secondary Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable") Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours. Patients will be evaluated at the first 24 hours period postoperatively.
Secondary The use of rescue analgesia The need for rescue analgesia will be recorded at the first 24 hours period postoperatively. Meperidine consumption will be recorded at the first 24 hours period postoperatively.
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