Post Operative PainNCT05684107
Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
A study testing IPACK block, adductor canal block and sciatic nerve block in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- IPACK block, adductor canal block and sciatic nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or II physical status
- undergoing elective major knee surgery
Who cannot join
- refusal of the patients to give informed consent,
- preexisting coagulation disorders,
- known allergies to aminoamide local anesthetics,
- local infection at the site of the block,
- morbid obesity,
- hepatic and renal diseases
- patients with psychological disorders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, University Hospitals
Shibīn al Kawm, Menoufia, 32511
Ghada Ali, MD, 01001775783, ghadaali132@yahoo.com
About this study
Official title: Femoral Nerve Block Combined With Sciatic Nerve Block Adductor Canal Block Or (Interspace Between The Popliteal Artery And The Capsule Of The Posterior Knee) IPACK Block For Postoperative Analgesia After Major Knee Surgeries
Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.
- Conditions
- Post Operative Pain
- Being tested
- IPACK block, adductor canal block, sciatic nerve block
- Keywords
- IPACK , Sciatic nerve block , adductor canal block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK blockProcedure or surgery
the probe is applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe is slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches is advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reached the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
adductor canal blockProcedure or surgery
the transducer is placed anteromedially, approximately at the junction between the middle and distal third of the thigh or somewhat lower.
The saphenous nerve block should be performed at the most distal level where the artery still lies immediately deep to the sartorius muscle, thus minimizing the amount of motor nerve block of the vastus medialis; an adductor canal nerve block is typically performed more proximally, around the mid-thigh level. The needle is inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip is visualized anterior to the artery and after careful aspiration, 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
sciatic nerve blockProcedure or surgery
patient in a supine position with the hip and knee on the operated side flexed and the leg externally rotated at approximately 45 degrees. The ultrasound transducer is first positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location is then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter is obtained. a spinal needle 22G x 3.5 inches is advanced parallel and in line with the ultrasound transducer while the sciatic nerve is kept in the middle of the screen. The needle is advanced slowly under real-time ultrasound guidance until it is near the nerve then negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn
| Study group | Role | What they receive |
|---|---|---|
| IPACK block | Active comparator | Not described Receives: Procedure: IPACK block |
| sciatic nerve block | Active comparator | Not described Receives: Procedure: sciatic nerve block |
| adductor canal block | Active comparator | Not described Receives: Procedure: adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of visual analogue scale
a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome
Measured: change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
Secondary outcomes (2)
time for fisrt analgesic request
when VAS is 4 or more longer time means a better outcome
Measured: up to 48 hours
total morphine consumption
intraoperative and post operative higher consumption means a worse outcome
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start1 Nov 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684107
- Sponsor's protocol ID
- 10/2022ANETH2
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Nerve Block Combined With Sciatic Nerve Block Adductor Canal Block Or (Interspace Between The Popliteal Artery And The Capsule Of The Posterior Knee) IPACK Block For Postoperative Analgesia After Major Knee Surgeries
- ClinicalTrials.gov ID
- NCT05684107
- Acronym / sponsor ID
- 10/2022ANETH2
- Conditions
- Post Operative Pain
- Keywords
- IPACK , Sciatic nerve block , adductor canal block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 13 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 between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPACK block | Active comparator | Procedure: IPACK block |
| sciatic nerve block | Active comparator | Procedure: sciatic nerve block |
| adductor canal block | Active comparator | Procedure: adductor canal block |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I or II physical status
- undergoing elective major knee surgery
Key exclusion criteria (7 listed)
- refusal of the patients to give informed consent,
- preexisting coagulation disorders,
- known allergies to aminoamide local anesthetics,
- local infection at the site of the block,
- morbid obesity,
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 |
|---|---|---|
| IPACK blockthe probe is applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe is slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches is advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reached the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn | Procedure or surgery | IPACK block |
| adductor canal blockthe transducer is placed anteromedially, approximately at the junction between the middle and distal third of the thigh or somewhat lower. The saphenous nerve block should be performed at the most distal level where the artery still lies immediately deep to the sartorius muscle, thus minimizing the amount of motor nerve block of the vastus medialis; an adductor canal nerve block is typically performed more proximally, around the mid-thigh level. The needle is inserted in-plane in a lateral-to-medial orientation and advanced toward the femoral artery. Once the needle tip is visualized anterior to the artery and after careful aspiration, 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn | Procedure or surgery | adductor canal block |
| sciatic nerve blockpatient in a supine position with the hip and knee on the operated side flexed and the leg externally rotated at approximately 45 degrees. The ultrasound transducer is first positioned perpendicular to the skin approximately 8 cm distal to the inguinal crease. The location is then scanned by sliding and tilting the transducer until a clear transverse image of the hyperechoic sciatic nerve located posterior and medial to the lesser trochanter is obtained. a spinal needle 22G x 3.5 inches is advanced parallel and in line with the ultrasound transducer while the sciatic nerve is kept in the middle of the screen. The needle is advanced slowly under real-time ultrasound guidance until it is near the nerve then negative aspiration is confirmed and 20 ml of bupivacaine 0.25% is injected incrementally as the needle was withdrawn | Procedure or surgery | sciatic nerve block |
Primary outcome
change of visual analogue scale
Time frame: change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
a scale from 0 to 10 as the patient will be asked to express his pain on the scale higher scale means a worse outcome
2 secondary outcomes
time for fisrt analgesic request
Time frame: up to 48 hours
total morphine consumption
Time frame: up to 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPACK block, adductor canal block and sciatic nerve block in people with Post Operative Pain, run by Menoufia 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 13 Jan 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa saieed saieed mansour, MD (01225484055, mostafa.said@med.menofia.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of visual analogue scale (time frame: change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2023.