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

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.

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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