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

Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty In Terms Of Postoperative Pain Control And Early Mobilization

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.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee; Anesthesia and Analgesia; Nerve Block; Anesthesia, Conduction
• Intervention / Treatment: Procedure: Ultrasound Guided Middle Adductor Canal Block; Drug: Bupivacain; Procedure: Spinal Anesthesia; Procedure: Ultrasound Guided Femoral Nerve 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 Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35170
    • Izmir Bozyaka Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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; Other Names: Regional Anesthesia; Drug: Bupivacain; 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution; Other Names: Marcain; Procedure: 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.
Active Comparator: 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.	Drug: Bupivacain; 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution; Other Names: Marcain; Procedure: 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.; Procedure: Ultrasound Guided Femoral Nerve Block.; Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution; Other Names: Regional Anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bozyaka Training and Research Hospital
• Investigators: Study Director: Zeki Tuncel Tekgül, Izmir Bozyaka Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 16, 2021
• Primary Completion (Anticipated): October 16, 2021
• Study Completion (Anticipated): April 16, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: knee arthroplasty; femoral nerve block; adductor block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Bupivacaine
• Other Study ID Numbers: elifgoktas

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No