NCT06683313

Brief Summary

Comparison of the combination of popliteal sciatic and femoral block with the combination of ipack adductor canal blocks and mobilization and analgesia duration in elective knee surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

May 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

4 months

First QC Date

November 8, 2024

Last Update Submit

November 8, 2024

Conditions

Keywords

femoral blockknee surgerysciatic nerve blockIPACK blockAdductor Canal Blockpost-operative analgesia

Outcome Measures

Primary Outcomes (1)

  • postoperative first mobilization time

    After receiving spinal anesthesia, patients undergoing elective knee surgery were taken to the operating room. Postoperatively, patients were randomly assigned into two groups using a closed-envelope method. In the first group, patients in the supine position received an adductor canal block with 20 ml of 0.025% bupivacaine and an IPACK block with an additional 20 ml of 0.025% bupivacaine. In the second group, patients in the supine position received a femoral nerve block with 20 ml of 0.025% bupivacaine and a sciatic nerve block administered via the popliteal region with an additional 20 ml of 0.025% bupivacaine. Motor block, analgesia, and mobilization times were assessed at the 2nd, 4th, 8th, and 24th hours postoperatively.In the postoperative period, patients' motor functions were assessed at specific intervals (e.g., at the 2nd, 4th, 8th, 12th and 24th hours) using the Bromage Scale. During each assessment, patients were asked to move their hip, knee, and ankle joints.

    24 hour

Secondary Outcomes (1)

  • Numerical Rating Scale (NRS) Scores

    24 hour

Study Arms (2)

adductor canal block add ipack

Patients who received ipack add femoral canal block for postoperative analgesia

Combination Product: combination adductor canal and IPACK block

femoral block add popliteal sciatic

Patients who underwent popliteal sciatic block add femoral block for postoperative analgesia

Combination Product: combination femoral nerve and popliteal sciatica block

Interventions

Combination of femoral nerve and popliteal sciatica block performed after knee surgery

Also known as: group FS
femoral block add popliteal sciatic

Combination of adductor canal and IPACK block performed after knee surgery

Also known as: group AI
adductor canal block add ipack

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged 18 to 75 who will undergo knee surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gaziosmanpasa Research and Education Hospital, Istanbul, 34000

Istanbul, 34000, Turkey (Türkiye)

Location

Gaziosmanpasa Research and Education Hospital, Istanbul, 34000

Istanbul, 34255, Turkey (Türkiye)

Location

Study Officials

  • osman çelik

    Gaziosmanpasa Research and Education Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

May 1, 2023

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

It will be shared upon request from the corresponding author via email if desired.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
2 year
Access Criteria
Those who are healthcare professionals

Locations