AzTrials
AzTrials

Postoperative PainNCT05672784

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

A study testing GNB plus standard analgesia, GNB plus IPACK block plus standard analgesia and standard analgesia (paracetamol and meloxicam) in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
GNB plus standard analgesia, GNB plus IPACK block plus standard analgesia and standard analgesia (paracetamol and meloxicam)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
1 siteEgypt
Study dates
5 Nov 2022to 30 Dec 2024
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • Patients with coronary disease
  • Patients with bronchial asthma
  • Patients with bleeding disorders
  • Patients with compromised renal or hepatic function
  • pregnant female.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Heba M Fathi

    Zagazig

    heba m fathi, M.D, 01000143938 ext. 002, heba_elgendi@yahoo.com

    Recruiting

Other trials in Egypt

About this study

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

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.

Being tested
GNB plus standard analgesia, GNB plus IPACK block plus standard analgesia, standard analgesia (paracetamol and meloxicam)
Keywords
genicular ,IPACK, total knee
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GNB plus standard analgesiaProcedure or surgery

    Also called genicular block and 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)

  • GNB plus IPACK block plus standard analgesiaProcedure or surgery

    Also called genicular bock and IPACK block and 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

  • standard analgesia (paracetamol and meloxicam)Drug

    Also called standard analgesia with no nerve block

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

Study groups in NCT05672784
Study groupRoleWhat they receive
C groupActive comparatorthe patients will take standard analgesia ( meloxicam (15 mg) once a day + paracetamol 1gm /3 times a day). ,with no nerve block
Receives: Drug: standard analgesia (paracetamol and meloxicam)
G groupActive comparatorthe patients will take standard analgesia plus GNB
Receives: Procedure: GNB plus standard analgesia; Drug: standard analgesia (paracetamol and meloxicam)
GI groupActive comparatorthe patients will take standard analgesia plus GNB plus IPACK
Receives: Procedure: GNB plus IPACK block plus standard analgesia; Drug: standard analgesia (paracetamol and meloxicam)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 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".

    Measured: 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".

    Measured: 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".

    Measured: 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".

    Measured: 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".

    Measured: 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".

    Measured: at 24 hours postoperative

Secondary outcomes (7)
  1. • Time of performance of block

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

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

  2. • Total morphine consumption

    Total morphine consumption

    Measured: at 24 hours post-operatively

  3. •incidence of Anticipated side effect

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

    Measured: 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

    Measured: at 24 hours post operative

  5. walk test

    walking distance in meters that patients can wake during 2 min

    Measured: at 24 hours post operative

  6. holding quadriceps muscle

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

    Measured: 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

    Measured: at 24 hours post operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2023
  2. Study start5 Nov 2022
  3. Primary completion5 Dec 2024 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05672784
Sponsor's protocol ID
9577/19-9-2022
Status last verified
Nov 2024
First submitted
5 Nov 2022
Last updated
26 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41318369

Questions about this trial

What is this clinical trial studying?

A study testing GNB plus standard analgesia, GNB plus IPACK block plus standard analgesia and standard analgesia (paracetamol and meloxicam) in people with Postoperative Pain, run by Zagazig University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Heba M Fathi, MD (01000143938 ext. 002, heba_elgendi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2 hours visual analogue scale (time frame: at 2 hour postoperative.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05672784, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.

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