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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04768764
• Other study ID #: elifgoktas
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 16, 2021
• Est. completion date: April 16, 2022

Study information

• Verified date: February 2021
• Source: Bozyaka Training and Research Hospital
• Contact: Elif Göktas
• Phone: 05062073485
• Email: e.goktas44[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: April 16, 2022
• Est. primary completion date: October 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

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.

Locations

Country	Name	City	State
Turkey	Izmir Bozyaka Training and Research Hospital	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Bozyaka Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Ambulation time	First time a patients can walk around independently	48 hours postoperatively
Primary	NRS at Ambulation	NRS when first time a patients can walk around independently	48 hours postoperatively
Secondary	Time of First Rescue Opioid	When patient's pain score(NRS) is 3 or more.	48 hours postoperatively
Secondary	Time of Return of Sensory Block	Examined with Prick Test	24 hours postoperatively
Secondary	Time of Return of Motor Block	Examined with Examined with Holmenn Skalasi	24 hours postoperatively