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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
genicular nerve block plus standard analgesia
genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
standard analgesia (paracetamol and meloxicam)
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring genicular ,IPACK, total knee

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 between 25 and 30 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.

Sites / Locations

  • Heba M FathiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

C group

G group

GI group

Arm Description

the patients will take standard analgesia (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24). ,with no nerve block

the patients will take standard analgesia plus genicular nerves block

the patients will take standard analgesia plus genicular nerves block plusinfiltration Between Popliteal Artery and Capsule of Posterior Knee

Outcomes

Primary Outcome Measures

1 hours visual analogue scale
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".
4 hours visual analogue score
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".
6 hours visual analogue score
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".
12 hours visual analogue score
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".
24 hours visual analogue score
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".
48 hours visual analogue score
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".

Secondary Outcome Measures

• Time of performance of block
defined as time from putting of U.S probe till the end of block procedure.
• Total morphine consumption
Total morphine consumption
•incidence of Anticipated side effect
nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.
blood presure
measured by noninvasive blood pressure monitoring
heart rate
heart rate measured by electrocardiography
oxygen saturation
measured by pulse oximeter
degree of maximum active flexion of the knee
degree of maximum active flexion of the knee comparing to the preoperative state
time of first mobilization after surgery
the first time when the patient start to walk( measured by hours )
walk test
walking distance in meters that patients can wake during 2 min)
walking more than 3 meters
number of patients capable to walk more than 3 meters
holding quadriceps muscle
number of patients capable to hold quadriceps muscle more than 5 seconds.

Full Information

First Posted
November 5, 2022
Last Updated
August 26, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05672784
Brief Title
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee
Official Title
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
October 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
comparing Genicular Nerve Block with its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After total Knee Arthroplasty
Detailed Description
comparing the use of Genicular Nerve Block versus its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee as a preemptive analgesia for Enhanced Recovery After total Knee Arthroplasty

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
genicular ,IPACK, total knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C group
Arm Type
Active Comparator
Arm Description
the patients will take standard analgesia (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24). ,with no nerve block
Arm Title
G group
Arm Type
Active Comparator
Arm Description
the patients will take standard analgesia plus genicular nerves block
Arm Title
GI group
Arm Type
Active Comparator
Arm Description
the patients will take standard analgesia plus genicular nerves block plusinfiltration Between Popliteal Artery and Capsule of Posterior Knee
Intervention Type
Procedure
Intervention Name(s)
genicular nerve block plus standard analgesia
Other Intervention Name(s)
genicular block and standard analgesia
Intervention Description
In supine position with a pillow under the popliteal fossa, a 12 MHz linear transducer (XarioTM SSA-660A, Toshiba Medical Systems Corporation, Otawara, Japan) will be placed parallel to the shaft of long bones of the legs. The target points will be next to superior lateral, superior medial, and inferior medial genicular arteries to block the superior lateral, superior medial, and inferior medial branches of genicular nerve. Identification will be done using color Doppler near the periosteal areas (the junctions of the epicondyle and the shafts of the femur and tibia, accordingly). The needle will be inserted in the plane of the ultrasound probe in the long-axis view. After confirming the placement of the needle-tip next to the genicular arteries, a 2.5 mL of bupivacaine (5%) will be injected at each target points.
Intervention Type
Procedure
Intervention Name(s)
genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
Other Intervention Name(s)
genicular bock and IPACK block and standard analgesia
Intervention Description
IPACK block will be performed in supine position with flexion of the knee in 45o. low frequency transducer at a depth of 3.5-4 cm will be placed transversely over the medial aspect of the knee, 2-3 cm above the patella, with sliding the transducer proximally and distally to identify the distal part of the shaft of the femur and the popliteal artery ( If the two femoral condyles appear first, proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared). Advance the needle in plane toward the space between the popliteal artery and the femur then 15 ml of bupivacaine 0.5% will be injected plus genicular nerve block
Intervention Type
Drug
Intervention Name(s)
standard analgesia (paracetamol and meloxicam)
Other Intervention Name(s)
standard analgesia with no nerve block
Intervention Description
(paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).
Primary Outcome Measure Information:
Title
1 hours visual analogue scale
Description
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".
Time Frame
at1hour after recovery from spinal anesthesia.
Title
4 hours visual analogue score
Description
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".
Time Frame
at 4 hours after recovery from spinal anesthesia
Title
6 hours visual analogue score
Description
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".
Time Frame
at 6 hours after recovery from spinal anesthesia
Title
12 hours visual analogue score
Description
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".
Time Frame
at 12 hours after recovery from spinal anesthesia
Title
24 hours visual analogue score
Description
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".
Time Frame
at 24 hours after recovery from spinal anesthesia
Title
48 hours visual analogue score
Description
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".
Time Frame
at 48 hours after recovery from spinal anesthesia
Secondary Outcome Measure Information:
Title
• Time of performance of block
Description
defined as time from putting of U.S probe till the end of block procedure.
Time Frame
from putting of U.S probe till the end of block procedure
Title
• Total morphine consumption
Description
Total morphine consumption
Time Frame
at 24, 48 hours postoperatively
Title
•incidence of Anticipated side effect
Description
nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.
Time Frame
at 24,48 hours postoperative
Title
blood presure
Description
measured by noninvasive blood pressure monitoring
Time Frame
measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative
Title
heart rate
Description
heart rate measured by electrocardiography
Time Frame
measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative
Title
oxygen saturation
Description
measured by pulse oximeter
Time Frame
measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative
Title
degree of maximum active flexion of the knee
Description
degree of maximum active flexion of the knee comparing to the preoperative state
Time Frame
at 24 and 48 hours post operative
Title
time of first mobilization after surgery
Description
the first time when the patient start to walk( measured by hours )
Time Frame
at 24 and 48 hours post operative
Title
walk test
Description
walking distance in meters that patients can wake during 2 min)
Time Frame
at 24 and 48 hours post operative
Title
walking more than 3 meters
Description
number of patients capable to walk more than 3 meters
Time Frame
at 24 and 48 hours post operative
Title
holding quadriceps muscle
Description
number of patients capable to hold quadriceps muscle more than 5 seconds.
Time Frame
at 24 and 48 hours post operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 between 25 and 30 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba M Fathi, MD
Phone
01000143938
Ext
002
Email
heba_elgendi@yahoo.com
Facility Information:
Facility Name
Heba M Fathi
City
Zagazig
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
heba m fathi, M.D
Phone
01000143938
Ext
002
Email
heba_elgendi@yahoo.com

12. IPD Sharing Statement

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

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