Post Operative PainNCT07046377
Comparison Between Two Blocks in Analgesia After Knee Arthroplasty
A study testing ACB - IPACK and GNB - IPACK in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparative Study between Adductor canal block combined with infiltration OF The interspace between popliteal artery and the capsule of the knee block versus genicular nerves Block combined with IPACK in Postoperative analgesia after knee replacement surgery Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- ACB - IPACK and GNB - IPACK
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2025to 29 Jul 2025
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-85 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status Class I to III.
- Patients scheduled for unilateral TKA under spinal anesthesia.
Who cannot join
- Patient's refusal.
- American Society of Anesthesiologists (ASA) Physical Status Class above III.
- local infection.
- History of allergy to the medications used in the study. 5. Psychiatric disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Adductor Canal Block Combined With (IPACK) Block Versus Genicular Nerves Block Combined With (IPACK) Block Regarding Postoperative Analgesic Effect After Knee Replacement Surgery.
Comparative Study between Adductor canal block combined with infiltration OF The interspace between popliteal artery and the capsule of the knee block versus genicular nerves Block combined with IPACK in Postoperative analgesia after knee replacement surgery
Read the detailed description
Patient informed written consent and ethical committee approval of Faculty of Medicine; Ain Shams University will be obtained before patient allocation.
- Study procedures: Supervisors and experts will do all the study procedures.
Patients undergoing unilateral Total knee replacement (TKR) will be randomly assigned into one of the following groups using computer generated codes (15 patients in each group):
Group 1 (ACB - IPACK group): will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.
Group 2 (GNB - IPACK group): will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.
- Conditions
- Post Operative Pain
- Being tested
- ACB - IPACK, GNB - IPACK
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACB - IPACKProcedure or surgery
will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.
GNB - IPACKProcedure or surgery
will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Adductor canal block + IPACK group Receives: Procedure: ACB - IPACK |
| Group 2 | Active comparator | Genicular nerves block + IPACK block. Receives: Procedure: GNB - IPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Comparing both groups regarding the time needed ( in hours) for the first call rescue analgesia post operatively.
Total knee replacement (TKR) is a well-known popular surgical procedure for knee diseases, including end-stage knee osteoarthritis that causes severe postoperative pain and prolonged immobility.
Acute pain control can be provided with multimodal analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. However, NSAIDs cause many side effects as peptic ulcer and gastritis, also opioids have gastrointestinal side effects as constipation, nausea and vomiting as well as respiratory depression.
Regional analgesia has been used as another modality to provide sufficient perioperative pain relief with minimal opioid consumption to avoid it's adverse effects peripheral nerve blocks (PNBs) is a common practice in orthopedic surgery. PNBs provide excellent pain management after TKA, promote early mobilization, and reduce the consumption of opioids, the incidence of opioid-related adverse effects, and the hospital stay
Measured: 5 minutes after ending of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start29 Jan 2025
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Jul 2025 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai Ma Abd ElAziz, MBBCH, Principal investigator, Ain Shams UniversityMai Ma Abd ElAziz Ibrahim, MBBCH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046377
- Sponsor's protocol ID
- FMASU MS64/2025
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once Study is completed
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Adductor Canal Block Combined With (IPACK) Block Versus Genicular Nerves Block Combined With (IPACK) Block Regarding Postoperative Analgesic Effect After Knee Replacement Surgery.
- ClinicalTrials.gov ID
- NCT07046377
- Acronym / sponsor ID
- FMASU MS64/2025
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Jul 2025 (estimated)
- First posted
- 1 Jul 2025 (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.
Comparative Study between Adductor canal block combined with infiltration OF The interspace between popliteal artery and the capsule of the knee block versus genicular nerves Block combined with IPACK in Postoperative analgesia after knee replacement surgery
Detailed description
Patient informed written consent and ethical committee approval of Faculty of Medicine; Ain Shams University will be obtained before patient allocation.
- Study procedures: Supervisors and experts will do all the study procedures.
Patients undergoing unilateral Total knee replacement (TKR) will be randomly assigned into one of the following groups using computer generated codes (15 patients in each group):
Group 1 (ACB - IPACK group): will receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block.
Group 2 (GNB - IPACK group): will recieve spinal anesthesia and US guided Genicular nerves block and IPACK block.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: ACB - IPACKAdductor canal block + IPACK group |
| Group 2 | Active comparator | Procedure: GNB - IPACKGenicular nerves block + IPACK block. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 30-85 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) Physical Status Class I to III.
- Patients scheduled for unilateral TKA under spinal anesthesia.
Key exclusion criteria (4 listed)
- Patient's refusal.
- American Society of Anesthesiologists (ASA) Physical Status Class above III.
- local infection.
- History of allergy to the medications used in the study. 5. Psychiatric disorder.
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 |
|---|---|---|
| ACB - IPACKwill receive spinal anesthesia and ultrasound-guided Adductor canal nerve block, as well as infiltration of the space between the popliteal artery and the capsule of the posterior knee (IPACK) block. | Procedure or surgery | Group 1 |
| GNB - IPACKwill recieve spinal anesthesia and US guided Genicular nerves block and IPACK block. | Procedure or surgery | Group 2 |
Primary outcome
1- Comparing both groups regarding the time needed ( in hours) for the first call rescue analgesia post operatively.
Time frame: 5 minutes after ending of operation
Total knee replacement (TKR) is a well-known popular surgical procedure for knee diseases, including end-stage knee osteoarthritis that causes severe postoperative pain and prolonged immobility. Acute pain control can be provided with multimodal analgesia, including non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. However, NSAIDs cause many side effects as peptic ulcer and gastritis, also opioids have gastrointestinal side effects as constipation, nausea and vomiting as well as respiratory depression. Regional analgesia has been used as another modality to provide sufficient perioperative pain relief with minimal opioid consumption to avoid it's adverse effects peripheral nerve blocks (PNBs) is a common practice in orthopedic surgery. PNBs provide excellent pain management after TKA, promote early mobilization, and reduce the consumption of opioids, the incidence of opioid-related adverse effects, and the hospital stay
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 1 Jul 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once Study is completed
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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.
Mai Ma Abd ElAziz, MBBCH principal investigator
Ain Shams University
Mai Ma Abd ElAziz Ibrahim, MBBCH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACB - IPACK and GNB - IPACK in people with Post Operative Pain, run by Ain Shams 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Comparing both groups regarding the time needed ( in hours) for the first call rescue analgesia post operatively. (time frame: 5 minutes after ending of operation). 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 1 Jul 2025.