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

NCT05672784 | Recruiting

• 1 other identifier: 9577/19-9-2022
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Keywords

genicular ,IPACK, total knee

Outcome Measures

Primary Outcomes (7)

• 2 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".

  at 2 hour postoperative.

• 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".

  at 4 hours postoperative

• 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".

  at 6 hours postoperative

• 8 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".

  at 8 hours postopertaive

• 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".

  at 12 hours postoperative

• 18 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".

  at 18 hours postoperative

• 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".

  at 24 hours postoperative

Secondary Outcomes (7)

• • Time of performance of block

  from putting of U.S probe till the end of block procedure

• • Total morphine consumption

  at 24 hours post-operatively

• •incidence of Anticipated side effect

  at 24,48 hours postoperative

• degree of maximum active flexion and extension of the knee

  at 24 hours post operative

• walk test

  at 24 hours post operative

Study Arms (3)

C group

ACTIVE COMPARATOR

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)

G group

ACTIVE COMPARATOR

the patients will take standard analgesia plus GNB

Procedure: GNB plus standard analgesia; Drug: standard analgesia (paracetamol and meloxicam)

GI group

ACTIVE COMPARATOR

the patients will take standard analgesia plus GNB plus IPACK

Procedure: GNB plus IPACK block plus standard analgesia; Drug: standard analgesia (paracetamol and meloxicam)

Interventions

GNB plus standard analgesia 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)

Also known as: genicular block and standard analgesia

G group

GNB plus IPACK block plus standard analgesia 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

Also known as: genicular bock and IPACK block and standard analgesia

GI group

standard analgesia (paracetamol and meloxicam) DRUG

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

Also known as: standard analgesia with no nerve block

C group; G group; GI group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Heba M Fathi

Zagazig, Egypt

RECRUITING

Related Publications (1)

• Fathi HM, Fahmy AM, Shaker MA, Kamel AAF. Comparison of genicular nerve block and its combination with IPACK block for analgesia and recovery after total knee arthroplasty: a randomized trial. BMC Anesthesiol. 2025 Nov 29;25(1):601. doi: 10.1186/s12871-025-03408-0.

  PMID: 41318369 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Meloxicam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Thiazines; Sulfur Compounds; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Heba M Fathi, MD

CONTACT

01000143938; heba_elgendi@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Heba M Fathi

Study Record Dates

• First Submitted: November 5, 2022
• First Posted: January 5, 2023
• Study Start: November 5, 2022
• Primary Completion: December 5, 2024
• Study Completion: December 30, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

EG (1)