Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block )No acronymNCT05794685
The Analgesic Efficacy of Ultrasound Guided Adductor Canal Block Versus 4 in 1 Block in Patients Undergoing Knee Surgeries: A Comparative Randomized Double Blinded Study .
A study testing adductor canal block and 4 in one block in people with Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block ), run by Mahmoud Hussein Bahr at 1 site in Egypt.
Trial summary
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block )
- What is being tested?
- adductor canal block and 4 in one block
- Type of treatment
- Injection or infusion, 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 Apr 2023to 1 Jan 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sexes.
- ASA grade 1 and 2.
- Age group between 20-60 years.
- Patients who will undergo knee surgeries under neuroaxial anesthesia.
Who cannot join
- Patient refusal.
- Patients who are allergic to any of study drugs.
- Absolute contraindication causes to spinal anesthesia due to coagulopathy, severe aortic/mitral stenosis, or active infection at site of injection
Trial locations and contacts
1 site in 1 country.
About this study
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019)
Read the detailed description
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019). Regarding the functional anatomy of the nerve supply to knee joint: The knee is innervated by genicular branches from the nerve to vastus medialis, saphenous nerve, sciatic nerve and the posterior division of obturator nerve. The skin around the knee is supplied by the cutaneous branches from the femoral nerve and the saphenous nerve (Ritesh Roy, Gaurav Agarwal, et al, 2018). The widespread use of ultrasound to advance peripheral nerve block techniques over the past decade has led to enormous growth in the utilization and efficiency of regional anesthesia (Cozowicz, Crispiana \& Poeran, et al, 2015). The adductor canal block (ACB) is an interfascial plane block performed in the middle third of the medial side of the thigh. The adductor canal bounded anteriorly by the sartorius muscle, posteriorly and medially by the adductor longus and magnus muscles, and laterally by the vastus medialis muscle. It contains the femoral vein and artery, the saphenous nerve and the nerve to the vastus medialis, both are sensory branches of the femoral nerve. In some individuals, the obturator sensory branch (also a femoral nerve branch) can be affected by local anesthetic infiltration into this area. It can be noted that this block affect sensory branches and avoid blocking the majority of motor branches. The block is most commonly performed using ultrasound guidance (Thiayagarajan MK, Kumar SV,et al 2019). Ultrasound guided 4-in-1 block technique: a new single injection technique described by Roy R, Agarwal G, et al, 2018 for the combined 4 nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) with a single injection point is located at the adductor hiatus where descending genicular artery branches from superficial femoral artery. Bupivacaine is a long-acting amide local anesthetic (max. dose 2.5 mg/kg). Symptoms contributed to local anesthetic toxicity include tinnitus, perioral tingling, visual disturbances and dizziness (Shafiei FT, McAllister RK, Lopez J, 2022)
- Being tested
- adductor canal block, 4 in one block
- Keywords
- ultrasound guided adductor canal block ., 4 in 1 block ., knee surgeries .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block).
4 in one blockProcedure or surgery
patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block).
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block | Active comparator | adductor canal block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle Receives: Procedure: adductor canal block; Procedure: 4 in one block |
| 4 in one block | Active comparator | 4 in one block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery . Receives: Procedure: adductor canal block; Procedure: 4 in one block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score: resting and dynamic .
Postoperative pain score: resting and dynamic pain using NRS at postoperative 6 hours.Numerical rating scales (NRSs) are the simplest and most commonly used scales. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around (written version) the number that best describes the pain dimension, usually intensity.
Measured: 6 hours Postoperative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 12 hours.
Measured: 12 hours post operative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 18 hours.
Measured: 18 hours post operative
Postoperative pain score: resting and dynamic
Postoperative pain score: resting and dynamic pain using NRS at postoperative 24 hours.
Measured: 24 hours post operative.
Secondary outcomes (3)
Change of blood pressure .
Change of blood pressure (systolic, diastolic, mean pressure): Evaluation of the blood pressure before and 30min after applying the assigned block before receiving anesthesia. Then, we will calculate the change of blood pressure at the two time points.
Measured: Intraoperative
Change of heart rate .
Change of heart rate: Evaluation of the heart rate before and 30 min after applying the assigned block before receiving anesthesia. Then, we will calculate the change of heart rate at the two time-points
Measured: Intraoperative
Postoperative opioid requirements .
First time for opioid rescue and total dose in the frist 24 hours.
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block )Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative Randomized Study between 2 groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahmoud Hussein Bahr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Hussein Bahr, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794685
- Sponsor's protocol ID
- FMBSUREC/12022023/saad
- Acronym
- No acronym
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Ultrasound Guided Adductor Canal Block Versus 4 in 1 Block in Patients Undergoing Knee Surgeries: A Comparative Randomized Double Blinded Study .
- ClinicalTrials.gov ID
- NCT05794685
- Acronym / sponsor ID
- No acronym / FMBSUREC/12022023/saad
- Keywords
- ultrasound guided adductor canal block ., 4 in 1 block ., knee surgeries .
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mahmoud Hussein BahrUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 Apr 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.
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019)
Detailed description
Knee surgeries are associated with severe postoperative pain. Improper pain management affects patients' psychological status with prolongation of hospital stay time and rehabilitation period, with the possibility of progression of the acute pain to chronic pain (McCartney CJ, Nelligan K., 2014). Many Pain management options following these surgeries are available: non-opioid analgesics, opioids and regional anesthesia techniques (epidural and peripheral nerve block). Multi-modal analgesia is considered the best option for pain management in knee surgeries. As non-opioid analgesics alone are not effective enough while opioids alone are associated with many risk factors: nausea, vomiting, decrease intestinal motility and respiratory depression with possibility of addiction (Goode VM, Morgan B, et al, 2019). Regarding the functional anatomy of the nerve supply to knee joint: The knee is innervated by genicular branches from the nerve to vastus medialis, saphenous nerve, sciatic nerve and the posterior division of obturator nerve. The skin around the knee is supplied by the cutaneous branches from the femoral nerve and the saphenous nerve (Ritesh Roy, Gaurav Agarwal, et al, 2018). The widespread use of ultrasound to advance peripheral nerve block techniques over the past decade has led to enormous growth in the utilization and efficiency of regional anesthesia (Cozowicz, Crispiana \& Poeran, et al, 2015). The adductor canal block (ACB) is an interfascial plane block performed in the middle third of the medial side of the thigh. The adductor canal bounded anteriorly by the sartorius muscle, posteriorly and medially by the adductor longus and magnus muscles, and laterally by the vastus medialis muscle. It contains the femoral vein and artery, the saphenous nerve and the nerve to the vastus medialis, both are sensory branches of the femoral nerve. In some individuals, the obturator sensory branch (also a femoral nerve branch) can be affected by local anesthetic infiltration into this area. It can be noted that this block affect sensory branches and avoid blocking the majority of motor branches. The block is most commonly performed using ultrasound guidance (Thiayagarajan MK, Kumar SV,et al 2019). Ultrasound guided 4-in-1 block technique: a new single injection technique described by Roy R, Agarwal G, et al, 2018 for the combined 4 nerves (saphenous nerve, obturator nerve, nerve to vastus medialis and sciatic nerve) with a single injection point is located at the adductor hiatus where descending genicular artery branches from superficial femoral artery. Bupivacaine is a long-acting amide local anesthetic (max. dose 2.5 mg/kg). Symptoms contributed to local anesthetic toxicity include tinnitus, perioral tingling, visual disturbances and dizziness (Shafiei FT, McAllister RK, Lopez J, 2022)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Comparative Randomized Study between 2 groups
| Arm | Type | Receives |
|---|---|---|
| adductor canal block | Active comparator | Procedure: adductor canal block, Procedure: 4 in one blockadductor canal block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle |
| 4 in one block | Active comparator | Procedure: adductor canal block, Procedure: 4 in one block4 in one block : patients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery . |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both sexes.
- ASA grade 1 and 2.
- Age group between 20-60 years.
- Patients who will undergo knee surgeries under neuroaxial anesthesia.
Key exclusion criteria (3 listed)
- Patient refusal.
- Patients who are allergic to any of study drugs.
- Absolute contraindication causes to spinal anesthesia due to coagulopathy, severe aortic/mitral stenosis, or active 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 |
|---|---|---|
| adductor canal blockpatients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg of dexamethasone at a point anterior to the femoral artery, deep to the sartorius muscle (adductor canal block). | Procedure or surgery | 4 in one block, adductor canal block |
| 4 in one blockpatients will receive an injection of 30 ml of .25% of Bupivacaine including 4mg dexamethasone at the adductor hiatus where the descending genicular artery branches from superficial femoral artery (4 in one block). | Procedure or surgery | 4 in one block, adductor canal block |
Primary outcome
Postoperative pain score: resting and dynamic .
Time frame: 6 hours Postoperative
Postoperative pain score: resting and dynamic pain using NRS at postoperative 6 hours.Numerical rating scales (NRSs) are the simplest and most commonly used scales. The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable." The patient picks (verbal version) or draws a circle around (written version) the number that best describes the pain dimension, usually intensity.
Postoperative pain score: resting and dynamic
Time frame: 12 hours post operative
Postoperative pain score: resting and dynamic pain using NRS at postoperative 12 hours.
Postoperative pain score: resting and dynamic
Time frame: 18 hours post operative
Postoperative pain score: resting and dynamic pain using NRS at postoperative 18 hours.
Postoperative pain score: resting and dynamic
Time frame: 24 hours post operative.
Postoperative pain score: resting and dynamic pain using NRS at postoperative 24 hours.
3 secondary outcomes
Change of blood pressure .
Time frame: Intraoperative
Change of heart rate .
Time frame: Intraoperative
Postoperative opioid requirements .
Time frame: 24 hours post operative
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 19 Aug 2024.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adductor canal block and 4 in one block in people with Comparing the Analgesic Outcome by ( 4 in 1 Block ) & ( Adductor Canal Block ), run by Mahmoud Hussein Bahr 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 3 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 19 Aug 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?
Postoperative pain score: resting and dynamic . (time frame: 6 hours Postoperative). The study lists 4 primary outcomes in all. 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 19 Aug 2024.