NCT05751109

Brief Summary

To compare the efficacy and complications of IPACK and adductor canal block combination and epidural block in patients who will be operated for knee arthroscopy under spinal anesthesia.

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 all trials

Timeline
Completed

Started Aug 2022

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

1 year

First QC Date

September 22, 2022

Last Update Submit

January 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS) evaluation for postoperative pain

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    8. Hour

Secondary Outcomes (2)

  • Visual Analogue Scale (VAS) evaluation for postoperative pain

    1. Hour

  • Visual Analogue Scale (VAS) evaluation for postoperative pain

    24. Hour

Study Arms (2)

ipack+adductor canal block

The 40 patients received ACB + IPACK (Group 1, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time.

Procedure: ipack+adduktor kanal

epidural analgesia

The 40 patients received combine spinal epidural (Group 2, n = 40),. All patients were evaluated with VAS score for pain recorded at 1h, 8 h, postoperative day (POD) 1 and 3. month after the surgery. The secondary outcome measures assessed were movement time and discharge time.

Procedure: ipack+adduktor kanal

Interventions

nerve block

Also known as: kombine epidural
epidural analgesiaipack+adductor canal block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80 people

You may qualify if:

  • Those who consented to participate in the study
  • Patients over the age of 18 who will be operated on due to knee pathology
  • Patients to be operated under spinal anesthesia
  • Disease that will limit cooperation

You may not qualify if:

  • Patients under the age of 18
  • Patients to be operated under general anesthesia
  • Disease that will cause limited cooperation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Onur Karaoglu

Istanbul, Kağıthane, 34400, Turkey (Türkiye)

Location

Rasim Onur Karaoglu

Istanbul, Kağıthane, 34400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2022

First Posted

March 2, 2023

Study Start

August 1, 2022

Primary Completion

August 16, 2023

Study Completion

October 1, 2023

Last Updated

January 3, 2024

Record last verified: 2024-01

Locations