NCT07077720

Brief Summary

Objective: This study compares the effects of genicular nerve block (GNB) and periarticular injection (PAI), added to distal adductor canal block (ACB), on postoperative recovery quality (QoR-15), morphine use, and pain scores after total knee arthroplasty (TKA). Methods: Sixty patients received spinal anesthesia and distal ACB, then were randomized to GNB (Group G, n=30) or PAI (Group P, n=30). QoR-15, morphine consumption, VAS pain scores, nausea/vomiting, and side effects were evaluated.

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 postoperative-pain

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable postoperative-pain

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

January 30, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 1, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

July 1, 2025

Last Update Submit

July 12, 2025

Conditions

Postoperative PainRecovery

Keywords

Total Knee ArthroplastyGenicular nerve blocperiarticular injectionQoR-15

Outcome Measures

Primary Outcomes (1)

  • Postoperative 24th hour qor-15

    Postoperative 24th hour qor-15 score

    Postoperative 24th hour

Secondary Outcomes (4)

  • Postoperative 2nd, 6th, 12th, and 24th hour morphine consumption

    Postoperative 2nd, 6th, 12th, and 24th hour

  • Postoperative 2nd, 6th, 12th, and 24th hour resting VAS score

    Postoperative 2nd, 6th, 12th, and 24th hour

  • Postoperative 2nd, 6th, 12th, and 24th hour movement VAS score

    Postoperative 2nd, 6th, 12th, and 24th hour

  • Postoperative 2nd, 6th, 12th, and 24th hour adverse effects

    Postoperative 2nd, 6th, 12th, and 24th hour

Study Arms (2)

Grup G

ACTIVE COMPARATOR

Genicular nerve block

Procedure: genicular nerve blockProcedure: Addukctor canal blockProcedure: Spinal Anesthesia with Bupivacaine and Morphine

Grup P

ACTIVE COMPARATOR

Periarticular injecrion

Procedure: periarticular injectionProcedure: Addukctor canal blockProcedure: Spinal Anesthesia with Bupivacaine and Morphine

Interventions

genicular nerve blockPROCEDURE

genicular nerve block with a total of 15 mL of 0.25% bupivacaine preoperatively

Grup G
periarticular injectionPROCEDURE

periarticular injection prepared by the surgical team containing 8 mg morphine, 40 mg methylprednisolone, 0.3 mg adrenaline, 750 mg cefazolin, and 110 mg bupivacaine.

Grup P
Addukctor canal blockPROCEDURE

Addukctor canal block with 15ml %0.25 bupivacaine

Grup GGrup P
Spinal Anesthesia with Bupivacaine and MorphinePROCEDURE

Spinal Anesthesia with Bupivacaine(isobaris 15-18mg) and Morphine(100mcg)

Grup GGrup P

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for knee arthroplasty
  • Patients classified as ASA I, II, or III
  • Patients aged 18 years and older

You may not qualify if:

  • Patients with a known allergy to any of the drugs used in the study
  • Presence of infection near the puncture site
  • History or presence of neurological disorders (e.g., transient ischemic attack, syncope, dementia, etc.)
  • Known coagulation disorders
  • History of alcohol or substance abuse
  • Impaired consciousness
  • Chronic opioid use equal to or exceeding 60 mg of oral morphine equivalents per day
  • Pre-existing neuropathic pain
  • Hepatic failure, renal failure, or cardiac insufficiency
  • Uncontrolled diabetes mellitus
  • Pregnant or breastfeeding women
  • Refusal or inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem vakıf üniversitesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, SpinalBupivacaineMorphine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 22, 2025

Study Start

January 30, 2025

Primary Completion

June 15, 2025

Study Completion

July 3, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)