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.
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
- Recruiting
Heba M Fathi
Zagazig
heba m fathi, M.D, 01000143938 ext. 002, heba_elgendi@yahoo.com
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.
- Conditions
- Postoperative Pain
- 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 group | Role | What they receive |
|---|---|---|
| C group | Active comparator | the 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 group | Active comparator | the patients will take standard analgesia plus GNB Receives: Procedure: GNB plus standard analgesia; Drug: standard analgesia (paracetamol and meloxicam) |
| GI group | Active comparator | the 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.
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.
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
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
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
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
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
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)
• 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
• Total morphine consumption
Total morphine consumption
Measured: at 24 hours post-operatively
•incidence of Anticipated side effect
nausea, vomiting, itching, hemorrhage, bradycardia and hypotension.
Measured: at 24,48 hours postoperative
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
walk test
walking distance in meters that patients can wake during 2 min
Measured: at 24 hours post operative
holding quadriceps muscle
number of patients capable to hold quadriceps muscle more than 5 seconds.
Measured: 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
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.
- First posted5 Jan 2023
- Study start5 Nov 2022
- Primary completion5 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Heba M Fathi, Zagazig University
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05672784
- Acronym / sponsor ID
- 9577/19-9-2022
- Conditions
- Postoperative Pain
- Keywords
- genicular ,IPACK, total knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Nov 2022 (actual)
- Primary completion
- 5 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| C group | Active comparator | Drug: standard analgesia (paracetamol and meloxicam)the patients will take standard analgesia ( meloxicam (15 mg) once a day + paracetamol 1gm /3 times a day). ,with no nerve block |
| G group | Active comparator | Procedure: GNB plus standard analgesia, Drug: standard analgesia (paracetamol and meloxicam)the patients will take standard analgesia plus GNB |
| GI group | Active comparator | Procedure: GNB plus IPACK block plus standard analgesia, Drug: standard analgesia (paracetamol and meloxicam)the patients will take standard analgesia plus GNB plus IPACK |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNB plus standard analgesiaAlso: genicular block and standard analgesiaWhen 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) | Procedure or surgery | G group |
| GNB plus IPACK block plus standard analgesiaAlso: genicular bock and IPACK block and standard analgesiaIPACK 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 | Procedure or surgery | GI group |
| standard analgesia (paracetamol and meloxicam)Also: standard analgesia with no nerve block(paracetamol 1 gm 3 times a daily and meloxicam (15 mg) once aday. | Drug | C group, G group, GI group |
Primary outcome
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".
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".
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".
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".
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".
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".
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".
7 secondary outcomes
• Time of performance of block
Time frame: from putting of U.S probe till the end of block procedure
• Total morphine consumption
Time frame: at 24 hours post-operatively
•incidence of Anticipated side effect
Time frame: at 24,48 hours postoperative
degree of maximum active flexion and extension of the knee
Time frame: at 24 hours post operative
walk test
Time frame: at 24 hours post operative
holding quadriceps muscle
Time frame: at 24 hours post operative
time up and go (TUG)
Time frame: at 24 hours post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Derived from this study: PubMed 41318369Fathi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.