NCT05289427

Brief Summary

Comparison between the pain scores after total knee arthroplasty in patients receiving triple injection peri-sartorius (TIPS) block versus femoral nerve block (FNB)

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 Apr 2022

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

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2023

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

March 13, 2022

Last Update Submit

March 9, 2023

Conditions

Knee DiseaseNerve Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue scale (resting and dynamic, 11 point scale from 0 - 10 where 0 accounts for no pain and 10 accounts for worst pain)

    Compare the two groups regarding the visual analogue scale scores

    24 hours postoperatively

Secondary Outcomes (3)

  • Total postoperative morphine consumption

    24 hours postoperatively

  • Operated limb motor power

    24 hours postoperatively

  • Complications

    24 hours

Study Arms (2)

TIPS Block

EXPERIMENTAL

Group TIPS; patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision

Procedure: ultrasound guided triple injection peri-sartorius block

FNB

ACTIVE COMPARATOR

Group FNB; patients will receive femoral nerve block (FNB) before surgical incision

Procedure: Femoral Nerve Block

Interventions

ultrasound guided triple injection peri-sartorius blockPROCEDURE

Patients will receive ultrasound guided triple injection peri-sartorius block preoperatively before surgical incision

TIPS Block
Femoral Nerve BlockPROCEDURE

Patients will receive femoral nerve block (FNB) before surgical incision

FNB

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • BMI \> 35 kg/m2, Pre-existing neurological deficit, Any disability of the non-operated limb preventing fair mobilization, Known contraindications to peripheral nerve block (coagulopathy or infection at the site of injection), Chronic opioid users/abusers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, 21651, Egypt

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

April 1, 2022

Primary Completion

March 7, 2023

Study Completion

March 7, 2023

Last Updated

March 10, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Individual participant data that underlie the resultsrepoted in this article after deidentification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After statistical analysis
Access Criteria
Any

Locations

EG(1)