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

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: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: standard analgesia (paracetamol and meloxicam); Procedure: GNB plus standard analgesia; Procedure: GNB plus IPACK block plus standard analgesia

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: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba M Fathi, MD; Phone Number: 002 01000143938; Email: heba_elgendi@yahoo.com

Study Locations

• Egypt
  • Zagazig, Egypt
    • Recruiting
    • Heba M Fathi
    • Contact: heba m fathi, M.D; Phone Number: 002 01000143938; Email: heba_elgendi@yahoo.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Time of performance of block	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	nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.	at 24,48 hours postoperative
• Total morphine consumption	Total morphine consumption	at 24 hours post-operatively
degree of maximum active flexion and extension of the knee	the angle of maximum active flexion and extension of the knee	at 24 hours post operative
walk test	walking distance in meters that patients can wake during 2 min	at 24 hours post operative
holding quadriceps muscle	number of patients capable to hold quadriceps muscle more than 5 seconds.	at 24 hours post operative
time up and go (TUG)	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

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2022
• Primary Completion (Estimated): December 5, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: January 4, 2023
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: genicular ,IPACK, total knee
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam; Acetaminophen
• Other Study ID 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