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

Sponsor
Bozyaka Training and Research Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04768764
Collaborator
(none)
52
1
2
12
4.3

Study Details

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
  • 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
Anticipated 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.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
Anticipated Study Start Date :
Apr 16, 2021
Anticipated Primary Completion Date :
Oct 16, 2021
Anticipated Study Completion Date :
Apr 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 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.

    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
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Post-operative pain assessed by Numeric Rating Scale(NRS) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [At 6 months postoperatively]

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

    17. Ambulation time [48 hours postoperatively]

      First time a patients can walk around independently

    18. NRS at Ambulation [48 hours postoperatively]

      NRS when first time a patients can walk around independently

    Secondary Outcome Measures

    1. Time of First Rescue Opioid [48 hours postoperatively]

      When patient's pain score(NRS) is 3 or more.

    2. Time of Return of Sensory Block [24 hours postoperatively]

      Examined with Prick Test

    3. Time of Return of Motor Block [24 hours postoperatively]

      Examined with Examined with Holmenn Skalası

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 İzmir Bozyaka Training and Research Hospital İzmir Turkey 35170

    Sponsors and Collaborators

    • Bozyaka Training and Research Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Elif Göktaş, Anesthesiology Resident, Bozyaka Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT04768764
    Other Study ID Numbers:
    • elifgoktas
    First Posted:
    Feb 24, 2021
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Anesthesiology Resident, Bozyaka Training and Research Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2021