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RecruitingNCT05672784Updated Nov 26, 2024

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

An interventional study of GNB plus standard analgesia and GNB plus IPACK block plus standard analgesia in Postoperative Pain, sponsored by Zagazig University. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Zagazig University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Nov 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
63
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Postoperative Pain

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Keywords

  • genicular ,IPACK, total knee
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 63 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Zagazig University is the lead sponsor of 447 studies on the registry; 75 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
63 participants (estimated)

Study arms

  • 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)

  • Active comparator
    G group

    the patients will take standard analgesia plus GNB

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

  • Active comparator
    GI group

    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

  • ProcedureGNB 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)

    Also known as: genicular block and standard analgesia

  • ProcedureGNB 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

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

  • Drugstandard analgesia (paracetamol and meloxicam)

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

    Also known as: standard analgesia with no nerve block

06

What researchers measure

Primary outcomes

  1. 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".

    Time frame: at 2 hour postoperative.

  2. 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".

    Time frame: at 4 hours postoperative

  3. 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".

    Time frame: at 6 hours postoperative

  4. 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".

    Time frame: at 8 hours postopertaive

  5. 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".

    Time frame: at 12 hours postoperative

  6. 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".

    Time frame: at 18 hours postoperative

  7. 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".

    Time frame: at 24 hours postoperative

Secondary outcomes

  1. • Time of performance of block

    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

  2. • Total morphine consumption

    Total morphine consumption

    Time frame: at 24 hours post-operatively

  3. •incidence of Anticipated side effect

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

    Time frame: at 24,48 hours postoperative

  4. degree of maximum active flexion and extension of the knee

    the angle of maximum active flexion and extension of the knee

    Time frame: at 24 hours post operative

  5. walk test

    walking distance in meters that patients can wake during 2 min

    Time frame: at 24 hours post operative

  6. holding quadriceps muscle

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

    Time frame: at 24 hours post operative

  7. 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

    Time frame: at 24 hours post operative

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05672784
Lead sponsor
Zagazig University
Responsible party
Heba M Fathi (Dr. Heba M Fathi, Zagazig University) — Principal investigator
First posted
Jan 5, 2023
Start date
Nov 5, 2022
Primary completion
Dec 5, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Nov 26, 2024

Study contacts

Heba M Fathi, MD
Contact
heba_elgendi@yahoo.com
01000143938 ext. 002

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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