- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473559
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty. A Prospective Randomized Study
July 22, 2022 updated by: Marwa Ahmed Abogabal, Tanta University
Comparison Between i Pack Block and Post Tibial Nerve Block
Comparison Between the Effect of Infiltration Between the Popliteal Artery and Capsule of the Knee Block Versus Selective Tibial Nerve Block for Postoperative Analgesia in Patient Undergoing Total Knee Arthroplasty.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
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
-
-
-
Tanta, Egypt
- Tanta 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
40 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with osteoarthritis scheduled for a primary either partial or total knee arthroplasty • Patients aged 40-80 years with a body mass index of 18-36 kg/ m2 and an American Society of Anesthesiologists functional status of I-III Planned use of regional anesthesia
Exclusion Criteria:
• Patients younger than 40 years old and older than 80years.
- Hepatic or renal insufficiency.
- Patients undergoing general anesthesia.
- Allergy or intolerance to one of the study medications.
- BMI > 36
- Diabetes
- ASA of IV
- Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of >5mg/day for one month)
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: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Adductor canal block with Ipack block
|
Ultrasound guided
|
|
ACTIVE_COMPARATOR: Adductor canal block with selective tibial nerve block
|
Ultrasound guided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption
Time Frame: 24 hours post operative
|
24 hours
|
24 hours post operative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marwa Abogabal, MD, Tanta University
- Principal Investigator: Wafaa Abdelwahed, MD, Tanta University
- Principal Investigator: Wafaa Abdelsalam, MD, Kafr elsheikh university
- Principal Investigator: Shaimaa Zahra, Tanta University
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)
January 1, 2022
Primary Completion (ACTUAL)
June 15, 2022
Study Completion (ACTUAL)
June 30, 2022
Study Registration Dates
First Submitted
July 22, 2022
First Submitted That Met QC Criteria
July 22, 2022
First Posted (ACTUAL)
July 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
July 26, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 35151/12/21
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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