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

NCT04768764 | Unknown Phase 4 DMC

• 1 other identifier: elifgoktas
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

femoral nerve block; adductor block; knee arthroplasty

Outcome Measures

Primary Outcomes (18)

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 0th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 0th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 2nd hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 2nd hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 4th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 4th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 6th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 6th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 8th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 8th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 12th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 12th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 24th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 24th hour postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient according to NRS

  At 6 months postoperatively

• Post-operative pain assessed by Numeric Rating Scale(NRS)

  Pain scores will be recorded as reported by the patient while knee flexion according to NRS

  At 6 months postoperatively

• Ambulation time

  First time a patients can walk around independently

  48 hours postoperatively

• NRS at Ambulation

  NRS when first time a patients can walk around independently

  48 hours postoperatively

Secondary Outcomes (3)

• Time of First Rescue Opioid

  48 hours postoperatively

• Time of Return of Sensory Block

  24 hours postoperatively

• Time of Return of Motor Block

  24 hours postoperatively

Study Arms (2)

Group 1 Middle Adductor Canal Block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound Guided Middle Adductor Canal Block; Drug: Bupivacain; Procedure: Spinal Anesthesia

Group 2 Femoral Nerve Block.

ACTIVE COMPARATOR

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.

Procedure: Ultrasound Guided Femoral Nerve Block.; Drug: Bupivacain; Procedure: Spinal Anesthesia

Interventions

Ultrasound Guided Middle Adductor Canal Block PROCEDURE

Middle adductor canal block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution

Also known as: Regional Anesthesia

Group 1 Middle Adductor Canal Block

Ultrasound Guided Femoral Nerve Block. PROCEDURE

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

Also known as: Regional Anesthesia

Group 2 Femoral Nerve Block.

Bupivacain DRUG

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

Also known as: Marcain

Group 1 Middle Adductor Canal Block; Group 2 Femoral Nerve Block.

Spinal Anesthesia 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 1 Middle Adductor Canal Block; Group 2 Femoral Nerve Block.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

İzmir Bozyaka Training and Research Hospital

Izmir, 35170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Anesthesia, Conduction; Bupivacaine; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Zeki Tuncel Tekgül

  İzmir Bozyaka Training and Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Elif Göktaş

CONTACT

05062073485; e.goktas44@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Resident

Model Details: There are two groups: the first group is adductor block and the second group is femoral block.

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 24, 2021
• Study Start: April 16, 2021
• Primary Completion: October 16, 2021
• Study Completion: April 16, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)