Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05672784

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Other names: genicular block and standard analgesia

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

Other names: genicular bock and IPACK block and standard analgesia

standard analgesia (paracetamol and meloxicam)

Drug

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

Other names: standard analgesia with no nerve block

Primary outcomes

  1. 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".

  2. 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".

  3. 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".

  4. 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".

  5. 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".

  6. 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".

  7. 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".

Secondary outcomes

  1. • 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.

  2. • Total morphine consumption

    Time frame: at 24 hours post-operatively

    Total morphine consumption

  3. •incidence of Anticipated side effect

    Time frame: at 24,48 hours postoperative

    nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.

  4. 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

  5. walk test

    Time frame: at 24 hours post operative

    walking distance in meters that patients can wake during 2 min

  6. holding quadriceps muscle

    Time frame: at 24 hours post operative

    number of patients capable to hold quadriceps muscle more than 5 seconds.

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Heba M Fathi, MD

CONTACT

[email protected]

01000143938 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 5, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.