- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04995861
A Comparison Between The Analgesic Efficacy of Adductor Canal Block Alone and Adductor Canal With IPACK (Interspace Between Popliteal Artery and Capsule of the Knee) Block for Knee Surgeries
July 18, 2022 updated by: Mohammed Shabayek, Ain Shams University
A comparison between The analgesic efficacy of adductor canal block alone and adductor canal with IPACK (interspace between popliteal artery and capsule of the knee) block for knee surgeries
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt
- Ain shams university
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients undergoing knee surgery i.e. arthroscopy, total knee replacement, ACL repair.
- ASA physical status I to III
- Sex (males and females)
- Age 21-70 years.
Exclusion Criteria:
- Hypersensitivity to local anesthetics. Preexisting peripheral neuropathy. Infection near site of infections e.g. osteomyelitis, septic knee joint. Etc. Patient refusal. PAny contraindications for spinal anesthesia. ( eg: coagulopathy, use of anticoagulants
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Group A (adductor canal only)
Will recieve adductor canal block only
|
Peripheral nerve blocks
|
|
ACTIVE_COMPARATOR: Group AB (adductor canal + IPACK)
Will recieve both adductor canal block and IPACK
|
Peripheral nerve blocks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of post operative pain
Time Frame: One year
|
Using visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain)
|
One year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Range of movement and ambulation
Time Frame: One year
|
the range of movement (ROM) by assessing the degree of knee extension one day after the surgery, and ambulation distance assessed by the number of steps walked by the patient three days after the surgery.
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 20, 2021
Primary Completion (ANTICIPATED)
September 20, 2022
Study Completion (ANTICIPATED)
September 30, 2022
Study Registration Dates
First Submitted
July 24, 2021
First Submitted That Met QC Criteria
July 30, 2021
First Posted (ACTUAL)
August 9, 2021
Study Record Updates
Last Update Posted (ACTUAL)
July 19, 2022
Last Update Submitted That Met QC Criteria
July 18, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- AinShamsU Shabayek MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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