Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty

Phase 4

• Conditions: Arthroplasty, Replacement, Knee; Pain, Postoperative; Anesthesia and Analgesia; Anesthesia, Conduction; Nerve Block
• Interventions: Procedure: Ultrasound Guided Middle Adductor Canal Block; Procedure: Ultrasound Guided Femoral Nerve Block.; Drug: Bupivacain; Procedure: Spinal Anesthesia

• Registration Number: NCT04768764
• Lead Sponsor: Bozyaka Training and Research Hospital

Brief Summary

Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.

Detailed Description

All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll. Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group.Femoral block or middle adductor canal block will be applied to the patients.

Group1 (Group 1 Middle Adductor Canal Block) patients will be administered middle adductor canal block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.

Group2 (Femoral Nerve Block) patients will be administered femoral block with 20 ml 0.25% Bupivacaine by an experienced anesthesiologist.

The selected block will be applied with USG behind the curtain after the operation.Patients will be taken to the postoperative recovery unit.Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Post-operatively, patients will receive 1mg/kg Tramadol when Numeric Rating Scale(NRS) \> 3.The duration of the sensory and motor block and the mobilization of the patients will be recorded and compared.

0,2,4,6,8,12,24 of the patient pain scores at hour and 6 months, presence of sensory block and motor block, pain score when the patient is mobilized will be recorded.In addition, operation time, complications related to block, mobilization time, discharge day, and opioid need will be recorded.It will be recorded at what time the first opioid dose was administered after the block.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Study First Posted: 2021-02-24
• Last Update Posted: 2021-02-24
• Study Start: 2021-04-16
• Primary Completion: 2021-10-16
• Study Completion: 2022-04-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• ASA1-2-3 patients who will undergo unilateral elective primary total knee prosthesis surgery with consent for the study
• Patients whose operation has been successfully completed with spinal anesthesia

Exclusion Criteria

• Refusal of the patient to work
• Patients under 18 years of age
• Patients who have undergone an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, sedoanelgesia, laryngeal mask application, etc.)
• Those with known local anesthetic allergies
• Body mass index> 35 patient groups
• Skin infection at the injection site
• Coagulopathy and use of anticoagulant therapy
• Uncontrolled diabetic patients
• Uncooperative patient
• Physiological and emotional lability
• Prolonged surgical intervention
• Patient with limitation of mobilization and movement before the operation, other than the operation reason

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 Middle Adductor Canal Block	Ultrasound Guided Middle Adductor Canal Block	Ultrasound Guided Middle Adductor Canal Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Group 1 Middle Adductor Canal Block	Spinal Anesthesia	Ultrasound Guided Middle Adductor Canal Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Group 2 Femoral Nerve Block.	Ultrasound Guided Femoral Nerve Block.	Ultrasound Guided Femoral Nerve Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Group 2 Femoral Nerve Block.	Bupivacain	Ultrasound Guided Femoral Nerve Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Group 2 Femoral Nerve Block.	Spinal Anesthesia	Ultrasound Guided Femoral Nerve Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.
Group 1 Middle Adductor Canal Block	Bupivacain	Ultrasound Guided Middle Adductor Canal Block: 20 ml Bupivacaine 0.25% Injectable Solution will be administered for middle adductor canal block. 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution.

Primary Outcome Measures

Name	Time	Method
Post-operative pain assessed by Numeric Rating Scale(NRS)	At 6 months postoperatively	Pain scores will be recorded as reported by the patient while knee flexion according to NRS
NRS at Ambulation	48 hours postoperatively	NRS when first time a patients can walk around independently
Ambulation time	48 hours postoperatively	First time a patients can walk around independently

Secondary Outcome Measures

Name	Time	Method
Time of Return of Motor Block	24 hours postoperatively	Examined with Examined with Holmenn Skalası
Time of First Rescue Opioid	48 hours postoperatively	When patient's pain score(NRS) is 3 or more.
Time of Return of Sensory Block	24 hours postoperatively	Examined with Prick Test

Trial Locations

Locations (1)

İzmir Bozyaka Training and Research Hospital; 🇹🇷 İzmir, Turkey