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

NCT ID: NCT05672784

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-05
• Study Completion Date: 2024-12-30

Brief Summary

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

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

C group

the patients will take standard analgesia ( meloxicam (15 mg) once a day + paracetamol 1gm /3 times a day). ,with no nerve block

Group Type: ACTIVE_COMPARATOR

standard analgesia (paracetamol and meloxicam)

Intervention Type: DRUG

(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.

G group

the patients will take standard analgesia plus GNB

Group Type: ACTIVE_COMPARATOR

GNB plus standard analgesia

Intervention Type: PROCEDURE

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)

standard analgesia (paracetamol and meloxicam)

Intervention Type: DRUG

(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.

GI group

the patients will take standard analgesia plus GNB plus IPACK

Group Type: ACTIVE_COMPARATOR

GNB plus IPACK block plus standard analgesia

Intervention Type: PROCEDURE

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

standard analgesia (paracetamol and meloxicam)

Intervention Type: DRUG

(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.

Interventions

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)

Intervention Type: 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

Intervention Type: PROCEDURE

standard analgesia (paracetamol and meloxicam)

(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday.

Intervention Type: DRUG

Other Intervention Names

genicular block and standard analgesia; genicular bock and IPACK block and standard analgesia; standard analgesia with no nerve block

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 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Heba M Fathi

Dr. Heba M Fathi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heba M Fathi

Zagazig, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Heba M Fathi, MD

Role: CONTACT

heba_elgendi@yahoo.com

01000143938 ext. 002

Facility Contacts

heba m fathi, M.D

Role: primary

heba_elgendi@yahoo.com

01000143938 ext. 002

Other Identifiers

9577/19-9-2022

Identifier Type: -

Identifier Source: org_study_id