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

• ClinicalTrials.gov Identifier: NCT04768764
• Recruitment Status: Unknown
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Bozyaka Training and Research Hospital
• Information provided by (Responsible Party): Elif Göktaş, Bozyaka Training and Research Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthroplasty, Replacement, Knee; Pain, Postoperative; Anesthesia and Analgesia; Anesthesia, Conduction; Nerve Block	Procedure: Ultrasound Guided Middle Adductor Canal Block; Procedure: Ultrasound Guided Femoral Nerve Block.; Drug: Bupivacain; Procedure: Spinal Anesthesia	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: There are two groups: the first group is adductor block and the second group is femoral block.
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• 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
• Estimated Study Start Date: April 16, 2021
• Estimated Primary Completion Date: October 16, 2021
• Estimated Study Completion Date: April 16, 2022

Arms and Interventions

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 Name: Regional Anesthesia; Drug: Bupivacain; 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution; Other Name: 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.	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 Name: Regional Anesthesia; Drug: Bupivacain; 10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution; Other Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 0th hour postoperatively ]
   Pain scores will be recorded as reported by the patient according to NRS
2. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 0th hour postoperatively ]
   Pain scores will be recorded as reported by the patient while knee flexion according to NRS
3. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 2nd hour postoperatively ]
   Pain scores will be recorded as reported by the patient according to NRS
4. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 2nd hour postoperatively ]
   Pain scores will be recorded as reported by the patient while knee flexion according to NRS
5. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 4th hour postoperatively ]
   Pain scores will be recorded as reported by the patient according to NRS
6. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 4th hour postoperatively ]
   Pain scores will be recorded as reported by the patient while knee flexion according to NRS
7. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 6th hour postoperatively ]
   Pain scores will be recorded as reported by the patient according to NRS
8. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 6th hour postoperatively ]
   Pain scores will be recorded as reported by the patient while knee flexion according to NRS
9. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 8th hour postoperatively ]
   Pain scores will be recorded as reported by the patient according to NRS
10. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 8th hour postoperatively ]
    Pain scores will be recorded as reported by the patient while knee flexion according to NRS
11. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 12th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS
12. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 12th hour postoperatively ]
    Pain scores will be recorded as reported by the patient while knee flexion according to NRS
13. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 24th hour postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS
14. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 24th hour postoperatively ]
    Pain scores will be recorded as reported by the patient while knee flexion according to NRS
15. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 6 months postoperatively ]
    Pain scores will be recorded as reported by the patient according to NRS
16. Post-operative pain assessed by Numeric Rating Scale(NRS) [ Time Frame: At 6 months postoperatively ]
    Pain scores will be recorded as reported by the patient while knee flexion according to NRS
17. Ambulation time [ Time Frame: 48 hours postoperatively ]
    First time a patients can walk around independently
18. NRS at Ambulation [ Time Frame: 48 hours postoperatively ]
    NRS when first time a patients can walk around independently

Secondary Outcome Measures :

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

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Elif Göktaş; 05062073485; e.goktas44@hotmail.com

Locations

Turkey

İzmir Bozyaka Training and Research Hospital

İzmir, Turkey, 35170

Contact: Zeki Tuncel Tekgül, Assoc. Prof. 05058554705 zekittekgul@yahoo.com

Sub-Investigator: Elif Göktaş, MD

Sponsors and Collaborators

Bozyaka Training and Research Hospital

Investigators

• Study Director: Zeki Tuncel Tekgül; İzmir Bozyaka Training and Research Hospital

More Information

• Responsible Party: Elif Göktaş, Anesthesiology Resident, Bozyaka Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04768764
• Other Study ID Numbers: elifgoktas
• First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Elif Göktaş, Bozyaka Training and Research Hospital:

femoral nerve block; adductor block; knee arthroplasty

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Bupivacaine; Anesthetics; Anesthetics, Local; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents