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

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05672784
Collaborator
(none)
63
1
3
6.8
9.3

Study Details

Study Description

Brief Summary

comparing Genicular Nerve Block with its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After total Knee Arthroplasty

Condition or Disease Intervention/Treatment Phase
  • Procedure: genicular nerve block plus standard analgesia
  • Procedure: genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
  • Drug: standard analgesia (paracetamol and meloxicam)
N/A

Detailed Description

comparing the use of Genicular Nerve Block versus its combination with infiltration Between Popliteal Artery and Capsule of Posterior Knee as a preemptive analgesia for Enhanced Recovery After total Knee Arthroplasty

Study Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee for Enhanced Recovery After Total Knee Arthroplasty
Actual Study Start Date :
Nov 5, 2022
Anticipated Primary Completion Date :
May 5, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: C group

the patients will take standard analgesia (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24). ,with no nerve block

Drug: standard analgesia (paracetamol and meloxicam)
(paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).
Other Names:
  • standard analgesia with no nerve block
  • Active Comparator: G group

    the patients will take standard analgesia plus genicular nerves block

    Procedure: genicular nerve block plus standard analgesia
    In supine position with a pillow under the popliteal fossa, a 12 MHz linear transducer (XarioTM SSA-660A, Toshiba Medical Systems Corporation, Otawara, Japan) will be placed parallel to the shaft of long bones of the legs. The target points will be next to superior lateral, superior medial, and inferior medial genicular arteries to block the superior lateral, superior medial, and inferior medial branches of genicular nerve. Identification will be done using color Doppler near the periosteal areas (the junctions of the epicondyle and the shafts of the femur and tibia, accordingly). The needle will be inserted in the plane of the ultrasound probe in the long-axis view. After confirming the placement of the needle-tip next to the genicular arteries, a 2.5 mL of bupivacaine (5%) will be injected at each target points.
    Other Names:
  • genicular block and standard analgesia
  • Drug: standard analgesia (paracetamol and meloxicam)
    (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).
    Other Names:
  • standard analgesia with no nerve block
  • Active Comparator: GI group

    the patients will take standard analgesia plus genicular nerves block plusinfiltration Between Popliteal Artery and Capsule of Posterior Knee

    Procedure: genicular nerve block plus infiltration Between Popliteal Artery and Capsule of Posterior Knee plus standard analgesia
    IPACK block will be performed in supine position with flexion of the knee in 45o. low frequency transducer at a depth of 3.5-4 cm will be placed transversely over the medial aspect of the knee, 2-3 cm above the patella, with sliding the transducer proximally and distally to identify the distal part of the shaft of the femur and the popliteal artery ( If the two femoral condyles appear first, proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared). Advance the needle in plane toward the space between the popliteal artery and the femur then 15 ml of bupivacaine 0.5% will be injected plus genicular nerve block
    Other Names:
  • genicular bock and IPACK block and standard analgesia
  • Drug: standard analgesia (paracetamol and meloxicam)
    (paracetamol 1 gm thrice daily and meloxicam (15 mg) every 24).
    Other Names:
  • standard analgesia with no nerve block
  • Outcome Measures

    Primary Outcome Measures

    1. 1 hours visual analogue scale [at1hour after recovery from spinal anesthesia.]

      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 [at 4 hours after recovery from spinal anesthesia]

      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 [at 6 hours after recovery from spinal anesthesia]

      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. 12 hours visual analogue score [at 12 hours after recovery from spinal anesthesia]

      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. 24 hours visual analogue score [at 24 hours after recovery from spinal anesthesia]

      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. 48 hours visual analogue score [at 48 hours after recovery from spinal anesthesia]

      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 Outcome Measures

    1. • Time of performance of block [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 [at 24, 48 hours postoperatively]

      Total morphine consumption

    3. •incidence of Anticipated side effect [at 24,48 hours postoperative]

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

    4. blood presure [measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative]

      measured by noninvasive blood pressure monitoring

    5. heart rate [measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative]

      heart rate measured by electrocardiography

    6. oxygen saturation [measured every 15 minutes from beginning of surgery until the end of surgery then every hour during the 1st 48 hours post operative]

      measured by pulse oximeter

    7. degree of maximum active flexion of the knee [at 24 and 48 hours post operative]

      degree of maximum active flexion of the knee comparing to the preoperative state

    8. time of first mobilization after surgery [at 24 and 48 hours post operative]

      the first time when the patient start to walk( measured by hours )

    9. walk test [at 24 and 48 hours post operative]

      walking distance in meters that patients can wake during 2 min)

    10. walking more than 3 meters [at 24 and 48 hours post operative]

      number of patients capable to walk more than 3 meters

    11. holding quadriceps muscle [at 24 and 48 hours post operative]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 60 Years
    Sexes Eligible for Study:
    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 between 25 and 30 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Heba M Fathi Zagazig Egypt

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Heba M Fathi, Dr. Heba M Fathi, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05672784
    Other Study ID Numbers:
    • 9577/19-9-2022
    First Posted:
    Jan 5, 2023
    Last Update Posted:
    Jan 5, 2023
    Last Verified:
    Dec 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Heba M Fathi, Dr. Heba M Fathi, Zagazig University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2023