Post Operative PainNCT06404658
Analgesic Efficacy of Genicular Nerve Block Versus (IPack Block ) in Patients Undergoing (ACL) Repair
A study testing Genicular nerve block in people with Post Operative Pain, run by Beni-Suef University at 1 site in Egypt.
Trial summary
One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Genicular nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2024to 30 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 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) <40 kg/m2
Who cannot join
- -Patients were excluded if they refused consent.
- Patients who are Not cooperative.
- BMI >40 kg/m2.
- Allergy to local anesthetics.
- Patients with anticoagulation or bleeding problems.
- Previous nerve dysfunction.
- Physical status ASA class IV.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benisuef University Hospital
Benisuef
Mariana AbdElsayed Mansour, MD, 01222960009, mrmrsyk4@gmail.com
About this study
Official title: Analgesic Efficacy of Genicular Nerve Block Versus Local Anaesthetic Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK Block ) in Patients Undergoing Anterior Cruciate Ligament (ACL) Repair by Knee Arthroscopy . A Randomized Controlled Prospective Study .
One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.
Read the detailed description
The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery
- Conditions
- Post Operative Pain
- Being tested
- Genicular nerve 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.
Genicular nerve blockProcedure or surgery
patients who receive Genicular nerve block with spinal anathesia .
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | did not receive any block just spinal anathesia. |
| Genicular nerve block | Active comparator | patients who receive Genicular nerve block with spinal anathesia . Receives: Procedure: Genicular nerve block |
| IPACK block | Active comparator | patients who receive IPACK block with spinal anathesia. Receives: Procedure: Genicular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
Measuring pain intensity regarding mean visual analogue score (VAS score ) ranging from 0 (no pain) to 10 (the worst imaginable pain.
Measured: 48 hour
Secondary outcomes (5)
Ambulatory score
Ambulatory score from ( 0 to 2) (score of 0) is assigned if the activity cannot be performed despite substantial help
(score of 1 )is assigned if the activity is performed using personal physical support.
(score of 2) is assigned if the activity is performed independently.
Measured: Within 48 hour
Time of first rescue analgesia
the time to ask for the first post operative analgesia
Measured: within 24 hour
Total opioid consumption post operative
Total opioid consumption post operative
Measured: Within 24 hour
Incidence of occurrence of systemic toxicity
( hypotension ,arrthymias, bradycardia, cardiac arrest, oral numbness and convulsions
Measured: Within 24 hour
The length of hospital stay .
The length of hospital stay .
Measured: within one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start12 May 2024
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Oct 2024 (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.
- More trials run by Beni-Suef 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Soliman, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404658
- Sponsor's protocol ID
- FMBSUREC/02012024/Kamal
- Status last verified
- May 2024
- First submitted
- 8 Apr 2024
- Last updated
- 14 May 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Genicular Nerve Block Versus Local Anaesthetic Infiltration Between Popliteal Artery and Capsule of the Knee (IPACK Block ) in Patients Undergoing Anterior Cruciate Ligament (ACL) Repair by Knee Arthroscopy . A Randomized Controlled Prospective Study .
- ClinicalTrials.gov ID
- NCT06404658
- Acronym / sponsor ID
- FMBSUREC/02012024/Kamal
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 12 May 2024 (actual)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 8 May 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.
One of the most common injuries to the knee is an anterior cruciate ligament (ACL) sprain or tear due to trauma ACL damage is crippling and often requires repair with an arthroscopic method, which is an outpatient surgery. Nevertheless, patients experience severe postoperative pain on the first day after the ACL reconstruction.Efficient postsurgery pain management is an important part of patient recovery that is also crucial for their satisfaction.
Detailed description
The optimum role of peripheral nerve blocks in ACL reconstruction continue to be debated as a component of multi-modal analgesia . As such ,an ideal block for ACLR would target sensation but not motor function,have minimal complication risk,and be easily reproducible The genicular nerves include branches from the femoral, common peroneal, saphenous, tibial, and obturator nerves which innervate the knee capsule . The superolateral, superomedial, and inferomedial On the other hand, the interspace between the Popliteal Artery and Capsule of the Knee (IPACK) block provides analgesia on the posterior knee joint, and the application of a genicular or IPACK block has been be associated with promising outcomes following the ACLR surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –did not receive any block just spinal anathesia. |
| Genicular nerve block | Active comparator | Procedure: Genicular nerve blockpatients who receive Genicular nerve block with spinal anathesia . |
| IPACK block | Active comparator | Procedure: Genicular nerve blockpatients who receive IPACK block with spinal anathesia. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patient age from 18 to 45 years old Patient status ASA I - II Patient body mass index (BMI) <40 kg/m2
Key exclusion criteria (7 listed)
- -Patients were excluded if they refused consent.
- Patients who are Not cooperative.
- BMI >40 kg/m2.
- Allergy to local anesthetics.
- Patients with anticoagulation or bleeding problems.
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 |
|---|---|---|
| Genicular nerve blockpatients who receive Genicular nerve block with spinal anathesia . | Procedure or surgery | Genicular nerve block, IPACK block |
Primary outcome
VAS score
Time frame: 48 hour
Measuring pain intensity regarding mean visual analogue score (VAS score ) ranging from 0 (no pain) to 10 (the worst imaginable pain.
5 secondary outcomes
Ambulatory score
Time frame: Within 48 hour
Time of first rescue analgesia
Time frame: within 24 hour
Total opioid consumption post operative
Time frame: Within 24 hour
Incidence of occurrence of systemic toxicity
Time frame: Within 24 hour
The length of hospital stay .
Time frame: within one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
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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 Genicular nerve block in people with Post Operative Pain, run by Beni-Suef 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 1 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 14 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana AbdElsayed Mansour (01222960009 ext. MD, mrmrsyk4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: 48 hour). 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 14 May 2024.