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

NCT ID: NCT04768764

Last Updated: 2021-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2022-04-16

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.

Conditions

Arthroplasty, Replacement, Knee; Pain, Postoperative; Anesthesia and Analgesia; Anesthesia, Conduction; Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1 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 Type: ACTIVE_COMPARATOR

Ultrasound Guided Middle Adductor Canal Block

Intervention Type: PROCEDURE

Middle adductor canal block will be applied post-operatively with guidance of USG.

Drug:Bupivacaine 0.25% Injectable Solution

Bupivacain

Intervention Type: DRUG

10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution

Spinal Anesthesia

Intervention Type: PROCEDURE

Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.

Group 2 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 Type: ACTIVE_COMPARATOR

Ultrasound Guided Femoral Nerve Block.

Intervention Type: PROCEDURE

Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution

Bupivacain

Intervention Type: DRUG

10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution

Spinal Anesthesia

Intervention Type: PROCEDURE

Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.

Interventions

Ultrasound Guided Middle Adductor Canal Block

Middle adductor canal block will be applied post-operatively with guidance of USG.

Drug:Bupivacaine 0.25% Injectable Solution

Intervention Type: PROCEDURE

Ultrasound Guided Femoral Nerve Block.

Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution

Intervention Type: PROCEDURE

Bupivacain

10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

Spinal Anesthesia

Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.

Intervention Type: PROCEDURE

Other Intervention Names

Regional Anesthesia; Regional Anesthesia; Marcain

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bozyaka Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elif Göktaş

Anesthesiology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeki Tuncel Tekgül

Role: STUDY_DIRECTOR

İzmir Bozyaka Training and Research Hospital

Locations

İzmir Bozyaka Training and Research Hospital

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Elif Göktaş

Role: CONTACT

e.goktas44@hotmail.com

05062073485

Facility Contacts

Zeki Tuncel Tekgül, Assoc. Prof.

Role: primary

zekittekgul@yahoo.com

05058554705

Other Identifiers

elifgoktas

Identifier Type: -

Identifier Source: org_study_id