NCT07478783

Brief Summary

Total knee arthroplasty (TKA) is a common orthopedic procedure in which effective postoperative pain management is important for early mobilization and rehabilitation. Various regional anesthesia techniques are used as part of multimodal analgesia protocols to improve postoperative pain control. Genicular nerve block has recently been introduced as a potential motor-sparing technique that may enhance postoperative analgesia when used alone or in combination with other regional blocks. The aim of this randomized controlled study is to evaluate whether the addition of ultrasound-guided genicular nerve block to femoral nerve block improves early postoperative analgesia in patients undergoing primary unilateral total knee arthroplasty under combined spinal-epidural anesthesia. A total of 80 patients aged 18-80 years scheduled for elective primary unilateral TKA will be included and randomly assigned to two groups using sealed envelopes. One group will receive femoral nerve block alone (Group F), while the other group will receive femoral nerve block combined with genicular nerve block (Group FG). Postoperative pain scores using the visual analog scale (VAS), epidural patient-controlled analgesia consumption during the first 24 hours, and the time to additional analgesic requirement will be recorded and compared between the groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

Same day

First QC Date

March 8, 2026

Last Update Submit

March 21, 2026

Conditions

Keywords

Postoperative analgesiatotal knee replacemenetfemoral nerve blockcontrolled studyprospective

Outcome Measures

Primary Outcomes (2)

  • Title: 24-hour postoperative epidural analgesic consumption.Description: The total dose (in ml) of epidural analgesic consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours following total knee arthroplasty su

    Total volume (in ml) of the epidural analgesic solution (fentanyl and bupivacaine) consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours post-surgery.

    First 24 hours following the total knee arthroplasty (TKA) procedure

  • 24-hour postoperative epidural analgesic consumption.

    Total volume (in ml) of epidural analgesic solution (fentanyl and bupivacaine) consumed by the patient via the patient-controlled analgesia (PCA) device within the first 24 hours post-surgery

    First 24 hours following the total knee arthroplasty (TKA) procedure.

Study Arms (2)

Group F (Femoral Block Only)

ACTIVE COMPARATOR

Patients in this group received an ultrasound-guided femoral nerve block administered with 20 ml of 0.25% bupivacaine. All patients also received standardized multimodal analgesia, including epidural patient-controlled analgesia (PCA)

Procedure: Ultrasound-guided Femoral Nerve Block

Group FG (Combined Block)

EXPERIMENTAL

Patients in this group received a combination of an ultrasound-guided femoral nerve block (20 ml of 0.25% bupivacaine) and an ultrasound-guided genicular nerve block. The genicular nerve block targeted the superomedial, superolateral, inferomedial, and inferolateral genicular nerves, with 5 ml of 0.25% bupivacaine administered at each site. All patients also received standardized multimodal analgesia, including epidural patient-controlled analgesia (PCA).

Procedure: ltrasound-guided Genicular Nerve Block

Interventions

Administration of 20 ml of 0.25% bupivacaine to the femoral nerve under ultrasound guidance. This procedure was performed on patients in both Group F and Group FG

Group F (Femoral Block Only)

Administration of 5 ml of 0.25% bupivacaine to each of the four genicular nerve branches (superomedial, superolateral, inferomedial, and inferolateral) under ultrasound guidance. This procedure was performed only on patients in Group FG

Group FG (Combined Block)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥18 years
  • Scheduled for elective total knee replacement surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Planned to receive femoral nerve block with or without genicular nerve block
  • Ability to provide written informed consent

You may not qualify if:

  • Refusal to participate
  • Contraindication to regional anesthesia
  • Coagulopathy or ongoing anticoagulant therapy incompatible with nerve block
  • Infection at the injection site
  • Known allergy to local anesthetics
  • Severe hepatic or renal insufficiency
  • Cognitive impairment preventing pain assessment
  • Chronic opioid use or opioid dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ankara Bilkent City Hospital

Etimesgut, Ankara, 06790, Turkey (Türkiye)

Location

Ankara Bilkent City Hospital

Ankara, Turkey, Turkey (Türkiye)

Location

Related Publications (13)

  • Luo D, Fan Z, Yin W. Chronic post-surgical pain after total knee arthroplasty: a narrative review. Perioper Med (Lond). 2024 Nov 5;13(1):108. doi: 10.1186/s13741-024-00466-9.

  • Layera S, Aliste J, Bravo D, Saadawi M, Salinas FV, Tran Q. Motor-sparing nerve blocks for total knee replacement: A scoping review. J Clin Anesth. 2021 Feb;68:110076. doi: 10.1016/j.jclinane.2020.110076. Epub 2020 Oct 6.

  • Grape S, Kirkham KR, Baeriswyl M, Albrecht E. The analgesic efficacy of sciatic nerve block in addition to femoral nerve block in patients undergoing total knee arthroplasty: a systematic review and meta-analysis. Anaesthesia. 2016 Oct;71(10):1198-209. doi: 10.1111/anae.13568. Epub 2016 Jul 29.

  • Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.

  • Fonkoue L, Behets C, Kouassi JK, Coyette M, Detrembleur C, Thienpont E, Cornu O. Distribution of sensory nerves supplying the knee joint capsule and implications for genicular blockade and radiofrequency ablation: an anatomical study. Surg Radiol Anat. 2019 Dec;41(12):1461-1471. doi: 10.1007/s00276-019-02291-y. Epub 2019 Jul 23.

  • Akesen S, Akesen B, Atici T, Gurbet A, Ermutlu C, Ozyalcin A. Comparison of efficacy between the genicular nerve block and the popliteal artery and the capsule of the posterior knee (IPACK) block for total knee replacement surgery: A prospective randomized controlled study. Acta Orthop Traumatol Turc. 2021 Mar;55(2):134-140. doi: 10.5152/j.aott.2021.20187.

  • Sinha A, Arora D, Singh S, Das T, Biswas M. Evaluating Analgesic Efficacy of Single Femoral Nerve Block versus Combined Femoral-Sciatic Nerve Block Post Total Knee Arthroplasty. Anesth Essays Res. 2020 Apr-Jun;14(2):326-330. doi: 10.4103/aer.AER_78_20. Epub 2020 Oct 12.

  • Krishna Prasad GV. Post-operative analgesia techniques after total knee arthroplasty: A narrative review. Saudi J Anaesth. 2020 Jan-Mar;14(1):85-90. doi: 10.4103/sja.SJA_494_19. Epub 2020 Jan 6.

  • Kukreja P, Venter A, Mason L, Kofskey AM, Northern T, Naranje S, Ghanem E, Lawson PA, Kalagara H. Comparison of Genicular Nerve Block in Combination With Adductor Canal Block in Both Primary and Revision Total Knee Arthroplasty: A Retrospective Case Series. Cureus. 2021 Jul 29;13(7):e16712. doi: 10.7759/cureus.16712. eCollection 2021 Jul.

  • Liu Q, Wang A, Zhang J. The effects of local infiltration anesthesia and femoral nerve block analgesia after total knee arthroplasty: a systematic review and meta-analysis. Ann Transl Med. 2022 Feb;10(4):178. doi: 10.21037/atm-22-286.

  • Finkel KJ, Takata ET, Panza G, Stuart W, Kainkaryam P, Maffeo-Mitchell CL, Walker A. A Series of Peripheral Nerve Blocks Combined With Spinal Anesthesia Is Associated With Improved Outcomes Following Total Knee Arthroplasty: A Retrospective Study. Cureus. 2025 Apr 25;17(4):e83000. doi: 10.7759/cureus.83000. eCollection 2025 Apr.

  • Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20.

  • Lebleu J, Pauwels A, Poilvache H, Anract P, Belbachir A. Severe Postoperative Pain in Total Knee Arthroplasty Patients: Risk Factors, Insights and Implications for Pain Management via a Digital Health Approach. J Clin Med. 2023 Dec 15;12(24):7695. doi: 10.3390/jcm12247695.

Study Officials

  • Semih Baskan, Proffesor

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Based on your source, you should select the roles that were blinded. If only the outcomes assessor or patients were blinded, check the relevant boxes.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to two parallel groups. One group received ultrasound-guided femoral nerve block only (Group F), while the other group received a combination of femoral nerve block and genicular nerve block (Group FG). Postoperative pain scores and analgesic consumption were compared between the groups within the first 24 hours following total knee arthroplasty.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 18, 2026

Study Start

November 1, 2021

Primary Completion

November 1, 2021

Study Completion

February 28, 2022

Last Updated

March 25, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

he researchers will share de-identified individual participant data (IPD) underlying the results reported in this study, including demographic data (age, gender, BMI) and primary/secondary outcomes (24-hour epidural consumption and VAS scores). Data will be available to researchers who provide a methodologically sound research proposal approved by the principal investigator. Supporting documents, including the Study Protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF), will also be available. Access will be granted starting 9 months after publication and ending 36 months after the publication date. Data sharing is subject to a signed data access agreement and confirmation of institutional ethics committee approval for the requester's secondary analysis. Requests should be directed to the corresponding author.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Use this standard window to ensure compliance with medical journal expectations: Start Date: 9 months after publication of the study results. End Date: 36 months after publication of the study results.
Access Criteria
De-identified individual participant data (IPD) will be made available to researchers who provide a methodologically sound research proposal. The proposed research must aim to address specific clinical or statistical questions relevant to the study's scope (total knee arthroplasty analgesia). Proposals will be reviewed by the principal investigator to ensure scientific merit. Access will be granted following the signing of a data access agreement and confirmation of institutional ethics committee approval for the secondary analysis. Requests should be directed to the corresponding author via the official institutional email.

Locations