Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block Vs. Adductor Canal Block Alone

November 4, 2024 updated by: Ain Shams University

Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries

In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Abbassia
      • Cairo, Abbassia, Egypt, 00202
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Physical status: ASA 1 or 2
  • Age group: 21-40 years.
  • No sex predilection.
  • Patients undergoing arthroscopic knee surgery under spinal anesthesia.

Exclusion Criteria:

  • Patient refusal
  • Physical status: ASA III or above.
  • Patients with contraindications for spinal anesthesia.
  • Patients with history of drug allergies to study drugs.
  • Evidence of local infection at site of injection.
  • Neuromuscular pathology (example: - Multiple Sclerosis)

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A : Adductor canal block only
Patients will receive Adductor canal block under ultrasound guide of 20 ml bupivacaine 0.25%
Procedure: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected
The patients in group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the patients are placed in the supine position with the arms resting comfortably across the chest and the affected lower extremity is externally rotated. Adductor canal was identified beneath the sartorius muscle and 22-gauge 90-mm spinal needle is inserted from anterolateral to posteromedial direction at a point approximately at the junction between the middle and distal third of the thigh on the anteromedial femur, this location is called mid adductor canal, then 20 ml of 0.25% bupivacaine is injected in the canal
Active Comparator: Group B : Adductor canal + IPACK block
Patients will receive Adductor canal block and IPACK block under ultrasound guidance with 20 ml bupivacaine 0.25% for each block
Procedure: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%
The patients in Group B will receive adductor canal block as described in group A then IPACK block, in which the patients are placed in a supine position and knee is placed in position of 90° flexion. A low-frequency ultrasound probe is positioned in the popliteal crease 1 finger breadth above the patella, and a spinal needle is inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle is placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine is injected while the needle is being withdrawn after negative aspiration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.
Time Frame: 8 hours
Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study.
8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total pethidine consumption
Time Frame: 24 hours
Total pethidine consumption (in mg.) over 24-hour period post-operative
24 hours
The time till first analgesic requirement
Time Frame: as requested by patient
The time (in hours) after finishing of ultrasound guided IPACK or Adductor canal blocks till the patient's requirement for first analgesia postoperative in ward. (All patients will receive intravenous pethidine (30mg) when VAS > 4 at any time of assessment)
as requested by patient
The number of steps
Time Frame: 24 hours
ambulation distance assessed by the number of steps walked by the patient 24 hours after the surgery
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Morsi, M.B.B.CH, Anesthesia resident, Ain shams 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS42/2024

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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