Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee

November 22, 2024 updated by: Heba M Fathi, Zagazig University

Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After Total Knee Arthroplasty

Comparison of the analgesic and physical recovery effect of genicular nerve block (GNB) alone and (GNB + infiltration between popliteal artery and posterior capsule of the knee (IPACK) in patients undergoing total knee replacement

Study Overview

Status

Status

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

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

Comparison of preemptive analgesia of (GNB) with (GNB+ IPACK) on postoperative pain control and recovery of knee physical activity in patient undergoing total knee replacement.

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 (Estimated)

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.
63

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

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

21 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion criteria:

  • Adult patients aged between 21 to 60 years
  • undergoing primary unilateral elective total knee arthroplasty under spinal anesthesia
  • Having informed consents
  • patients with physical status ASA I & II
  • both genders
  • body mass index less than 40 kg/m2.

Exclusion criteria

  • patients with Peripheral vascular disease
  • patients with history of allergy to local anesthesia or opioid analgesia,
  • those on anti-platelet, anticoagulant or B blocker drugs
  • Patients with acute decompensated heart failure
  • Patients with hypertension
  • Patients with heart block
  • Patients with coronary disease
  • Patients with bronchial asthma
  • Patients with bleeding disorders
  • Patients with compromised renal or hepatic function
  • pregnant female.

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 Assignment
  • Masking: Single

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.
Active Comparator: C group
the patients will take standard analgesia ( meloxicam (15 mg) once a day + paracetamol 1gm /3 times a day). ,with no nerve block
Drug: standard analgesia (paracetamol and meloxicam)
(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.
Other Names:
  • standard analgesia with no nerve block
Active Comparator: G group
the patients will take standard analgesia plus GNB
Drug: standard analgesia (paracetamol and meloxicam)
(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.
Other Names:
  • standard analgesia with no nerve block
Procedure: GNB plus standard analgesia
When patients are in supine position with a pillow under the popliteal fossa, we will target points next to superior medial, superior lateral, and inferior medial genicular arteries to block the superior medial, superior lateral, and inferior medial branches of genicular nerve. For identification, we will use color Doppler near the periosteal areas (the junctions of the epicondyle with the shafts of the femur and tibia, accordingly). using a 12 MHz linear transducer (XarioTM SSA-660A, Toshiba Medical Systems Corporation, Otawara, Japan) positioned parallel to the shaft of the long bones in the legs, the needle will be inserted ( in plane technique in the long-axis view) and a 2.5 mL of bupivacaine (5%) will be injected at each target points.standard analgesia will be given post-operativelly (paracetamol 1 gm/ three times a daily and meloxicam (15 mg)once a day)
Other Names:
  • genicular block and standard analgesia
Active Comparator: GI group
the patients will take standard analgesia plus GNB plus IPACK
Drug: standard analgesia (paracetamol and meloxicam)
(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.
Other Names:
  • standard analgesia with no nerve block
Procedure: GNB plus IPACK block plus standard analgesia
IPACK block will be done when the patients in supine position with the knee flexed in 45 degree. using a low frequency transducer at a depth of 3.5-4 cm positioned transversely, 2-3 cm above the patella and over the medial aspect of the knee, we will identify the distal part of the shaft of the femur and the popliteal artery with sliding the transducer proximally and distally (If the two femoral condyles appear first, proximal sliding of the probe, so the humps of the femoral condyles will disappeared and the flat metaphysis will appeared). With advancement of the needle in plane toward the space between the popliteal artery and the femur, 15 ml of bupivacaine 0.5% will be injected. The genicular nerve block will be done as in group G and standard analgesia will be given post-operative as in group G
Other Names:
  • genicular bock and IPACK block and standard analgesia

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
2 hours visual analogue scale
Time Frame: at 2 hour postoperative.
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 2 hour postoperative.
4 hours visual analogue score
Time Frame: at 4 hours postoperative
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 4 hours postoperative
6 hours visual analogue score
Time Frame: at 6 hours postoperative
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 6 hours postoperative
8 hours visual analogue score
Time Frame: at 8 hours postopertaive
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 8 hours postopertaive
12 hours visual analogue score
Time Frame: at 12 hours postoperative
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 12 hours postoperative
18 hours visual analogue score
Time Frame: at 18 hours postoperative
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 18 hours postoperative
24 hours visual analogue score
Time Frame: at 24 hours postoperative
pain intensity at rest and with motion using visual analogue scale from " horizontal line of 10-cm long with two ends, one end indicate no pain 0 and the other end indicate worst pain 10".
at 24 hours postoperative

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
• Time of performance of block
Time Frame: from putting of U.S probe till the end of block procedure
defined as time from putting of U.S probe till the end of block procedure.
from putting of U.S probe till the end of block procedure
•incidence of Anticipated side effect
Time Frame: at 24,48 hours postoperative
nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.
at 24,48 hours postoperative
• Total morphine consumption
Time Frame: at 24 hours post-operatively
Total morphine consumption
at 24 hours post-operatively
degree of maximum active flexion and extension of the knee
Time Frame: at 24 hours post operative
the angle of maximum active flexion and extension of the knee
at 24 hours post operative
walk test
Time Frame: at 24 hours post operative
walking distance in meters that patients can wake during 2 min
at 24 hours post operative
holding quadriceps muscle
Time Frame: at 24 hours post operative
number of patients capable to hold quadriceps muscle more than 5 seconds.
at 24 hours post operative
time up and go (TUG)
Time Frame: at 24 hours post operative
the time required for the patient to stand up from a standard-height armchair, walk 3 meters, turn, walk back to the chair, and sit down
at 24 hours post operative

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.
Zagazig 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.
November 5, 2022

Primary Completion (Estimated)

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.
December 5, 2024

Study Completion (Estimated)

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.
December 30, 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).
November 5, 2022

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.
January 4, 2023

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.
January 5, 2023

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 26, 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 22, 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.
November 1, 2024

More Information

Terms related to this study

Keywords

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.
  • 9577/19-9-2022

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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