Postoperative PainNCT06265441
Comparison of Pain Relief Post Knee Arthroscopy Using IPACK + Adductor Canal Block Vs. Adductor Canal Block Alone
A study testing Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected and Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25% in people with Postoperative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries. Read more about this study
- Who is it for?
- Ages 21 to 40 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected and Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 1 Oct 2024
- 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 21 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physical status: ASA 1 or 2
- Age group: 21-40 years.
- No sex predilection.
- Patients undergoing arthroscopic knee surgery under spinal anesthesia.
Who cannot join
- Patient refusal
- Physical status: ASA III or above.
- Patients with contraindications for spinal anesthesia.
- Patients with history of drug allergies to study drugs.
- Evidence of local infection at site of injection.
- Neuromuscular pathology (example: - Multiple Sclerosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries
In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.
Read the detailed description
Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.
- Conditions
- Postoperative Pain
- Being tested
- Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected, Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injectedProcedure or surgery
The patients in group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the patients are placed in the supine position with the arms resting comfortably across the chest and the affected lower extremity is externally rotated. Adductor canal was identified beneath the sartorius muscle and 22-gauge 90-mm spinal needle is inserted from anterolateral to posteromedial direction at a point approximately at the junction between the middle and distal third of the thigh on the anteromedial femur, this location is called mid adductor canal, then 20 ml of 0.25% bupivacaine is injected in the canal
Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%Procedure or surgery
The patients in Group B will receive adductor canal block as described in group A then IPACK block, in which the patients are placed in a supine position and knee is placed in position of 90° flexion. A low-frequency ultrasound probe is positioned in the popliteal crease 1 finger breadth above the patella, and a spinal needle is inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle is placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine is injected while the needle is being withdrawn after negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Group A : Adductor canal block only | Experimental | Patients will receive Adductor canal block under ultrasound guide of 20 ml bupivacaine 0.25% Receives: Procedure: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected |
| Group B : Adductor canal + IPACK block | Active comparator | Patients will receive Adductor canal block and IPACK block under ultrasound guidance with 20 ml bupivacaine 0.25% for each block Receives: Procedure: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.
Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study.
Measured: 8 hours
Secondary outcomes (3)
Total pethidine consumption
Total pethidine consumption (in mg.) over 24-hour period post-operative
Measured: 24 hours
The time till first analgesic requirement
The time (in hours) after finishing of ultrasound guided IPACK or Adductor canal blocks till the patient's requirement for first analgesia postoperative in ward. (All patients will receive intravenous pethidine (30mg) when VAS > 4 at any time of assessment)
Measured: as requested by patient
The number of steps
ambulation distance assessed by the number of steps walked by the patient 24 hours after the surgery
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 posted20 Feb 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Morsi, M.B.B.CH, Principal investigator, Anesthesia resident, Ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265441
- Sponsor's protocol ID
- MS42/2024
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of IPACK Block with Adductor Canal Block Vs Adductor Canal Block Alone for Post Operative Analgesia Following Arthroscopic Knee Surgeries
- ClinicalTrials.gov ID
- NCT06265441
- Acronym / sponsor ID
- MS42/2024
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 20 Feb 2024 (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.
In this study, the invistigators aim to compare postoperative analgesia effectiveness between combined interspace between the popliteal artery and posterior capsule of the knee block (IPACK) and Adductor canal block vs. Adductor canal block alone after Arthroscopic knee surgeries.
Detailed description
Patients who fulfilled the inclusion criteria and agreed to participate in the study will be randomly divided into two groups using their computer-generated random numbers such that even numbers will be enrolled in group A for Adductor canal block alone and odd numbers will be enrolled in group B for Adductor canal block and IPACK block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A : Adductor canal block only | Experimental | Procedure: Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injectedPatients will receive Adductor canal block under ultrasound guide of 20 ml bupivacaine 0.25% |
| Group B : Adductor canal + IPACK block | Active comparator | Procedure: Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%Patients will receive Adductor canal block and IPACK block under ultrasound guidance with 20 ml bupivacaine 0.25% for each block |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Physical status: ASA 1 or 2
- Age group: 21-40 years.
- No sex predilection.
- Patients undergoing arthroscopic knee surgery under spinal anesthesia.
Key exclusion criteria (6 listed)
- Patient refusal
- Physical status: ASA III or above.
- Patients with contraindications for spinal anesthesia.
- Patients with history of drug allergies to study drugs.
- Evidence of local infection at site of injection.
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 |
|---|---|---|
| Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injectedThe patients in group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance (SonoSite™, Inc., Bothell, WA 98021, USA) in which the patients are placed in the supine position with the arms resting comfortably across the chest and the affected lower extremity is externally rotated. Adductor canal was identified beneath the sartorius muscle and 22-gauge 90-mm spinal needle is inserted from anterolateral to posteromedial direction at a point approximately at the junction between the middle and distal third of the thigh on the anteromedial femur, this location is called mid adductor canal, then 20 ml of 0.25% bupivacaine is injected in the canal | Procedure or surgery | Group A : Adductor canal block only |
| Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25%The patients in Group B will receive adductor canal block as described in group A then IPACK block, in which the patients are placed in a supine position and knee is placed in position of 90° flexion. A low-frequency ultrasound probe is positioned in the popliteal crease 1 finger breadth above the patella, and a spinal needle is inserted from the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur. The tip of the needle is placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine is injected while the needle is being withdrawn after negative aspiration. | Procedure or surgery | Group B : Adductor canal + IPACK block |
Primary outcome
Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure.
Time frame: 8 hours
Visual analogue scale (VAS) (scale 0-10, where 0 = no pain and 10 = worst imaginable pain). All the patients will have the VAS score explained and taught for self-assessment of pain at the time of enrolment for the study.
3 secondary outcomes
Total pethidine consumption
Time frame: 24 hours
The time till first analgesic requirement
Time frame: as requested by patient
The number of steps
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Mohamed Morsi, M.B.B.CH principal investigator
Anesthesia resident, 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 Group A will receive adductor canal block after spinal anesthesia under a high-frequency ultrasound guidance in which the adductor canal is identified and 20 ml of 0.25% bupivacaine will be injected and Group B will receive adductor canal block under ultrasound guide 20 ml bupivacaine 0.25% and IPACK block under direct visualization of ultrasound of 20 ml bupivacaine 0.25% in people with Postoperative 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 6 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: finished, as of the sponsor's last update on 5 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessment of pain using the visual analogue scale (VAS) at 2 hours, 4 hours, 6 hours, and 8 hours after the completion of the surgical procedure and skin closure. (time frame: 8 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 5 Nov 2024.