NCT05643040

Brief Summary

Central neuraxial and regional anesthesia and analgesia techniques significantly reduce perioperative morbidity and mortality in the knee and below-knee surgeries.Nerve blocks appear to have better analgesic efficacy compared to placebo or patient-controlled analgesia (PCA). In addition, opioid-related side effects such as postoperative nausea, vomiting, pruritus, sedation, and respiratory depression are less. Therefore, interest in regional blocks such as femoral, sciatic, adductor, combined femoral, and sciatic is increasing. The knee joint is innervated by various nerves (genicular nerves) from the femoral, obturator, and sciatic nerves, and a comprehensive but simple technique is needed for postoperative analgesia. Complete and comprehensive postoperative analgesia was possible with this block, a simple single injection technique. The aim of our study is to evaluate the intraoperative analgesia efficacy of femoral, adductor canal block, and 4in1 block in patients who will undergo knee surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

September 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2.8 years

First QC Date

November 23, 2022

Last Update Submit

June 30, 2025

Conditions

Keywords

4 in 1 blockfemoral blockadductor canal block

Outcome Measures

Primary Outcomes (1)

  • intraoperative analgesia efficacy

    The aim of our study is to evaluate the intraoperative analgesia efficacy of femoral, adductor canal block and 4in1 block in patients who will undergo knee surgery.

    perioperative period

Secondary Outcomes (1)

  • postoperative analgesia efficacy

    perioperative period

Study Arms (3)

femoral nerve block

EXPERIMENTAL

To evaluate the intraoperative analgesia effectiveness of femoral nerve block in patients who will have knee surgery.

Other: femoral nerve block

adductor canal block

EXPERIMENTAL

To evaluate the intraoperative analgesia effectiveness of adductor canal block in patients who will have knee surgery.

Other: adductor canal block

4in1 block

EXPERIMENTAL

To evaluate the intraoperative analgesia effectiveness of 4in1 block in patients who will have knee surgery.

Other: 4in1 block

Interventions

To evaluate the intraoperative analgesia effectiveness of femoral block in patients who will have knee surgery.

femoral nerve block

To evaluate the intraoperative analgesia effectiveness of adductor canal block in patients who will have knee surgery.

adductor canal block

To evaluate the intraoperative analgesia effectiveness of 4in1 block in patients who will have knee surgery.

4in1 block

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between the ages of \>18
  • undergone knee surgery
  • American Society of Anesthesiologists (ASA) classification I-III group.

You may not qualify if:

  • Patients who do not want to participate in the study coagulopathy peripheral neuropathy local anesthetic drug allergy chronic opioid users anticoagulant users pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medical Science, Yıldırım Beyazıt Training and Research Hospital

Ankara, 06000, Turkey (Türkiye)

Location

Related Publications (2)

  • Rodgers A, Walker N, Schug S, McKee A, Kehlet H, van Zundert A, Sage D, Futter M, Saville G, Clark T, MacMahon S. Reduction of postoperative mortality and morbidity with epidural or spinal anaesthesia: results from overview of randomised trials. BMJ. 2000 Dec 16;321(7275):1493. doi: 10.1136/bmj.321.7275.1493.

    PMID: 11118174BACKGROUND
  • Roy R, Agarwal G, Pradhan C, Kuanar D. Total postoperative analgesia for total knee arthroplasty: Ultrasound guided single injection modified 4 in 1 block. J Anaesthesiol Clin Pharmacol. 2020 Apr-Jun;36(2):261-264. doi: 10.4103/joacp.JOACP_260_19. Epub 2020 Jun 15.

    PMID: 33013045BACKGROUND

MeSH Terms

Conditions

Bites and StingsAgnosia

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Group I: Femoral nerve block Group II: Adductor canal block Group III: 4in1 block
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diskapi Yildirim Beyazit Education and Research Hospital

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 8, 2022

Study Start

September 1, 2022

Primary Completion

June 20, 2025

Study Completion

June 30, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations