Pain, PostoperativeNCT05271188
IPACK Block Versus Adductor Canal Block in High Tibeal Osteotomy
A study testing Infiltration of local anaesthetic between popliteal artery and posterior knee capsule in people with Pain, Postoperative, run by Assiut University.
Trial summary
A comparison between IPACK block and adductor canal block in post operative pain management Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Infiltration of local anaesthetic between popliteal artery and posterior knee capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2022to Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 40 - 60 years.
- American Society of Anesthiologist class ( ASA) I - III
- BMI 18-35 kg/m2
- Scheduled for primary unilateral open wedge high tibial osteotomy
Who cannot join
- Known allergy to local anesthetics
- Contraindication to local anesthetics injection e.g. infection at the site of injection
- Contraindication to spinal anesthesia e.g. coagulopathy.
- Patients with pre-existing motor or sensory deficits in lower extremities.
- Insulin or noninsulin dependent diabetes mellitus.
- systemic corticosteroid use within 30-days of surgery
Show all 9Show fewer
- difficulties in comprehending visual analog scale (VAS) pain scores
- history of arrhythmia or seizures
- severe renal insufficiency
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Infiltration of Local Anesthetic in the Interspace Between the Popliteal Artery and Capsule of the Posterior Knee "IPACK Block" Versus Adductor Canal Block "ACB" for Pain Relief After Open Wedge High Tibial Osteotomy
A comparison between IPACK block and adductor canal block in post operative pain management
Read the detailed description
Two groups of patients between 40 and 60 yrs who are undergoing open wedge high tibeal osteotomy Group 1 will receive IPACK block with 15 ml Bupivacaine, immediately before spinal anaesthesia .
Group 2 will receive adductor canal block ,also with 15 ml Bupivacaine. before spinal anaesthesia. register the time of first pain sensation and firs IV analgesic dose required in each group
- Conditions
- Pain, Postoperative
- Being tested
- Infiltration of local anaesthetic between popliteal artery and posterior knee capsule
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infiltration of local anaesthetic between popliteal artery and posterior knee capsuleProcedure or surgery
Also called Adductor canal block
Adductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function [8]. Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which is moderate to severe in intensity [9, 10]. The recent technique of an ultrasound (US)-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown to provide significant posterior knee analgesia without affecting the common peroneal nerve (CPN) [11]. We postulated that IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB
| Study group | Role | What they receive |
|---|---|---|
| Group 1 who will receive IPACK block | Active comparator | This group of patients will receive IPACK block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements Receives: Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsule |
| Group 2 who will receive adductor canal block | Active comparator | This group of patients will receive adductor canal block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements Receives: Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time of first pain sensation requiring analgesia
If intervention which is adductor canal block or lPACK block is effective in postoperative pain control that can decrease the lV analgesic agents
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start15 Mar 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of people who are undergoing open wedge high tibeal osteotomy aged between 40 and 60 yrs old not diabetic and neurologically free
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Hussein Ahmed Hussein, Assiut University
- Investigators
- Salwa Hussein, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271188
- Sponsor's protocol ID
- Pain control
- Status last verified
- Mar 2022
- First submitted
- 14 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infiltration of Local Anesthetic in the Interspace Between the Popliteal Artery and Capsule of the Posterior Knee "IPACK Block" Versus Adductor Canal Block "ACB" for Pain Relief After Open Wedge High Tibial Osteotomy
- ClinicalTrials.gov ID
- NCT05271188
- Acronym / sponsor ID
- Pain control
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 8 Mar 2022 (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.
A comparison between IPACK block and adductor canal block in post operative pain management
Detailed description
Two groups of patients between 40 and 60 yrs who are undergoing open wedge high tibeal osteotomy Group 1 will receive IPACK block with 15 ml Bupivacaine, immediately before spinal anaesthesia .
Group 2 will receive adductor canal block ,also with 15 ml Bupivacaine. before spinal anaesthesia. register the time of first pain sensation and firs IV analgesic dose required in each group
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of people who are undergoing open wedge high tibeal osteotomy aged between 40 and 60 yrs old not diabetic and neurologically free
| Arm | Type | Receives |
|---|---|---|
| Group 1 who will receive IPACK block | Active comparator | Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsuleThis group of patients will receive IPACK block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements |
| Group 2 who will receive adductor canal block | Active comparator | Procedure: Infiltration of local anaesthetic between popliteal artery and posterior knee capsuleThis group of patients will receive adductor canal block immediately before spinal anaesthesia then follow up for 24 hrs to register first pain sensation and analgesic requirements |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 40 - 60 years.
- American Society of Anesthiologist class ( ASA) I - III
- BMI 18-35 kg/m2
- Scheduled for primary unilateral open wedge high tibial osteotomy
Key exclusion criteria (9 listed)
- Known allergy to local anesthetics
- Contraindication to local anesthetics injection e.g. infection at the site of injection
- Contraindication to spinal anesthesia e.g. coagulopathy.
- Patients with pre-existing motor or sensory deficits in lower extremities.
- Insulin or noninsulin dependent diabetes mellitus.
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 |
|---|---|---|
| Infiltration of local anaesthetic between popliteal artery and posterior knee capsuleAlso: Adductor canal blockAdductor canal block (ACB) is a popular peripheral nerve block that has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function [8]. Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which is moderate to severe in intensity [9, 10]. The recent technique of an ultrasound (US)-guided local anesthetic infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) has shown to provide significant posterior knee analgesia without affecting the common peroneal nerve (CPN) [11]. We postulated that IPACK will provide better pain relief and improve knee function in the immediate postoperative period compared to ACB | Procedure or surgery | Group 1 who will receive IPACK block, Group 2 who will receive adductor canal block |
Primary outcome
the time of first pain sensation requiring analgesia
Time frame: 24 hours
If intervention which is adductor canal block or lPACK block is effective in postoperative pain control that can decrease the lV analgesic agents
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Salwa Hussein, Lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Infiltration of local anaesthetic between popliteal artery and posterior knee capsule in people with Pain, Postoperative, run by Assiut University.
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 9 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 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Salwa Hussein (01159460234, salwa94hussien@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time of first pain sensation requiring analgesia (time frame: 24 hours). 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 8 Mar 2022.