Adductor Canal BlockNCT06398717
Effect of Combining Peri-hamstring Injection or Anterior Obturator Nerve Block on the Analgesic Efficacy of Adductor Canal Block for Arthroscopic Anterior Cruciate Ligament Reconstruction Under General Anesthesia
A study testing adductor canal block in people with Adductor Canal Block, run by Ain Shams University.
Trial summary
Pain after anterior cruciate ligament reconstruction with autologous hamstring graft can be attributed to both arthroscopic surgery and the graft donor site. Many methods are available to provide postoperative analgesia for patients undergoing total knee arthroplasty, but it is unclear how they compare with each… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Adductor Canal Block
- What is being tested?
- adductor canal block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Jan 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 21-70 years
- Both sex
- Patients scheduled for elective arthroscopic anterior cruciate ligament reconstruction under general anesthesia.
- American Society of Anesthesiologists Physical Status Class I, II Patients.
- Body Mass Index <30 kg/m2.
Who cannot join
- History of allergy to the study medications.
- American Society of Anesthesiologists class ≥III.
- Patients refusal to participate in the study.
- The inability to comprehend or participate in the pain scoring system.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
- Psychiatric disorder and patient with any neurological disorder.
Show all 12Show fewer
- Opioid tolerance or dependence.
- Distorted anatomy.
- Peripheral neuropathy.
- Renal or hepatic impairment.
- Morbid obesity (Body Mass Index: >30kg/m2).
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Combining Peri-hamstring Injection or Anterior Obturator Nerve Block on the Analgesic Efficacy of Adductor Canal Block for Arthroscopic Anterior Cruciate Ligament Reconstruction Under General Anesthesia: A Randomised Controlled Trial.
Pain after anterior cruciate ligament reconstruction with autologous hamstring graft can be attributed to both arthroscopic surgery and the graft donor site. Many methods are available to provide postoperative analgesia for patients undergoing total knee arthroplasty, but it is unclear how they compare with each other. The extent to which the two techniques anterior division obturator nerve block vs peritendinous hamstring injection may benefit the patients in terms of overall analgesia and specifically the autograft site analgesia needs evaluation.
Read the detailed description
In induction room, standard anesthesia monitors, including Electrocardiogram, Non Invasive Blood Pressure, and pulse oximeter, will be connected. Baseline parameters such as mean arterial pressure, heart rate, and oxygen saturation will be recorded. An intravenous cannula of 18-gauge will be secured and intravenous lactated Ringer will be started, for all patients. The patients will be premedicated with Midazolam 0.02 mg/kg, fentanyl 50-100 μg IV titrated to effect, Granisetron 1 mg (undiluted) Intravenous push over 30 seconds and Proton pump inhibitor 40 mg. Patients will be placed in the supine position with the operative leg externally rotated. Asepsis will be achieved using chlorhexidine 2% in alcohol. The skin at block sites will be subsequently infiltrated with lidocaine 2%.
In group C: (n=26) every patient will receive unilateral adductor canal block alone, a pre-procedural scan using a 5 cm (7-13 MHz) high-frequency linear transducer will be performed to identify the location of the descending genicular artery arising from the superficial femoral artery. The finding of this vascular landmark is known to demark the exit (and subsequent bifurcation) of the saphenous nerve from the adductor canal just distal to the discontinuation of the vaso-adductor membrane. The injection point for the ACB will be 2 cm proximal to this landmark along the sartorius muscle. A 21-gauge 90 mm needle will pass in-plane in an anterolateral to posteromedial direction through the sartorius muscle. Once the needle tip location is confirmed (by hydro-location using dextrose 5%, 1-2 ml) to be lateral to the femoral artery but within the adductor canal, bupivacaine 0.25%, 20 ml will be injected after negative aspiration for blood .
In group H: (n=26) every patient will receive unilateral peri-hamstring injection combined to adductor canal block, After the completion of the Adductor canal block, the transducer will be moved further posteriorly around the thigh. The same needle will be redirected in a steeper posteromedial direction towards the fascial plane between the sartorius and gracilis muscle. Once the needle tip is confirmed to be deep to sartorius but superficial to gracilis, bupivacaine 0.25%, 7.5 ml will be injected superficially to the deep fascia of the muscle sheath to achieve free spread around the anterior surface of the muscle contained within the fascial compartment (as the muscle was viewed in short axis on ultrasound). The needle will then be advanced further posteriorly towards the fascial planes between the semimembranosus and semitendinosus, and an additional bupivacaine 0.25%, 7.5 ml will be similarly injected to achieve spread around the anterior aspect of the semitendinosus muscle superficial to its deep fascia .
In group O: (n=26) every patient will receive unilateral anterior obturator nerve block combined to adductor canal block, The anterior branch of the obturator nerve is seen in the proximal thigh medial to the femoral vessels between the adductor longus and adductor brevis below the inguinal crease. The same 21-gauge 90 mm needle will be directed through the adductor longus in an out of plane technique. A small volume of dextrose 5%, (1-2 ml) will be injected to ensure the needle tip is positioned between the two muscles. After negative aspiration, bupivacaine 0.25%, 10 ml will be injected in this muscle plane to surround the anterior division of obturator nerve.
- Conditions
- Adductor Canal Block
- Being tested
- adductor canal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal blockProcedure or surgery
Also called obturator canal block, peri-hamestring injection
group C will receive a unilateral adductor canal block alone, using an ultrasound to identify the location of the nerve.
group H will receive unilateral peri-hamstring injection combined to adductor canal block, After the adductor canal block, the transducer will be moved posteriorly till identifying the site of injection group O will receive unilateral anterior obturator nerve block combined with adductor canal block, The anterior branch of the obturator nerve is located using ultrasound
| Study group | Role | What they receive |
|---|---|---|
| group C: will receive unilateral adductor canal block alone | Active comparator | Not described Receives: Procedure: adductor canal block |
| group H:will receive unilateral peri-hamstring injection combined to adductor canal block | Active comparator | Not described Receives: Procedure: adductor canal block |
| group O: will receive unilateral anterior obturator nerve block combined to adductor canal block | Active comparator | Not described Receives: Procedure: adductor canal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain control
The postoperative visual analogue scale pain score.( from 0 to 10, 0 being "no pain" and 10 being "worst possible pain." )
Measured: 6 hours
Secondary outcomes (6)
pain controlling methods
The total dose of fentanyl was used intraoperatively.
The patients' satisfaction scores(using a 7-point Likert verbal rating scale after 24 hours (1-extremely dissatisfied, 2-dissatisfied, 3-somewhat dissatisfied, 4-undecided, 5-somewhat satisfied, 6-satisfied, and 7-extremely satisfied))
Measured: 24 hours
pain controlling methods
The total consumption of rescue analgesia in 24 hours.
Measured: 24 hours
pain controlling methods
The total number of patients who received intraoperative fentanyl.
Measured: 24 hours
pain controlling methods
The total number of patients who needed rescue analgesia.
Measured: 24 hours
pain controlling methods
The occurrence and severity of complications were noted postoperatively.
Measured: 24 hours
pain controlling methods
The patients' satisfaction scores(using a 7-point Likert verbal rating scale after 24 hours (1-extremely dissatisfied, 2-dissatisfied, 3-somewhat dissatisfied, 4-undecided, 5-somewhat satisfied, 6-satisfied, and 7-extremely satisfied))
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 posted3 May 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adductor Canal BlockStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim El-Desoukey, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398717
- Sponsor's protocol ID
- MD291/2023
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 3 May 2024
- 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 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combining Peri-hamstring Injection or Anterior Obturator Nerve Block on the Analgesic Efficacy of Adductor Canal Block for Arthroscopic Anterior Cruciate Ligament Reconstruction Under General Anesthesia: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06398717
- Acronym / sponsor ID
- MD291/2023
- Conditions
- Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 3 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.
Pain after anterior cruciate ligament reconstruction with autologous hamstring graft can be attributed to both arthroscopic surgery and the graft donor site. Many methods are available to provide postoperative analgesia for patients undergoing total knee arthroplasty, but it is unclear how they compare with each other. The extent to which the two techniques anterior division obturator nerve block vs peritendinous hamstring injection may benefit the patients in terms of overall analgesia and specifically the autograft site analgesia needs evaluation.
Detailed description
In induction room, standard anesthesia monitors, including Electrocardiogram, Non Invasive Blood Pressure, and pulse oximeter, will be connected. Baseline parameters such as mean arterial pressure, heart rate, and oxygen saturation will be recorded. An intravenous cannula of 18-gauge will be secured and intravenous lactated Ringer will be started, for all patients. The patients will be premedicated with Midazolam 0.02 mg/kg, fentanyl 50-100 μg IV titrated to effect, Granisetron 1 mg (undiluted) Intravenous push over 30 seconds and Proton pump inhibitor 40 mg. Patients will be placed in the supine position with the operative leg externally rotated. Asepsis will be achieved using chlorhexidine 2% in alcohol. The skin at block sites will be subsequently infiltrated with lidocaine 2%.
In group C: (n=26) every patient will receive unilateral adductor canal block alone, a pre-procedural scan using a 5 cm (7-13 MHz) high-frequency linear transducer will be performed to identify the location of the descending genicular artery arising from the superficial femoral artery. The finding of this vascular landmark is known to demark the exit (and subsequent bifurcation) of the saphenous nerve from the adductor canal just distal to the discontinuation of the vaso-adductor membrane. The injection point for the ACB will be 2 cm proximal to this landmark along the sartorius muscle. A 21-gauge 90 mm needle will pass in-plane in an anterolateral to posteromedial direction through the sartorius muscle. Once the needle tip location is confirmed (by hydro-location using dextrose 5%, 1-2 ml) to be lateral to the femoral artery but within the adductor canal, bupivacaine 0.25%, 20 ml will be injected after negative aspiration for blood .
In group H: (n=26) every patient will receive unilateral peri-hamstring injection combined to adductor canal block, After the completion of the Adductor canal block, the transducer will be moved further posteriorly around the thigh. The same needle will be redirected in a steeper posteromedial direction towards the fascial plane between the sartorius and gracilis muscle. Once the needle tip is confirmed to be deep to sartorius but superficial to gracilis, bupivacaine 0.25%, 7.5 ml will be injected superficially to the deep fascia of the muscle sheath to achieve free spread around the anterior surface of the muscle contained within the fascial compartment (as the muscle was viewed in short axis on ultrasound). The needle will then be advanced further posteriorly towards the fascial planes between the semimembranosus and semitendinosus, and an additional bupivacaine 0.25%, 7.5 ml will be similarly injected to achieve spread around the anterior aspect of the semitendinosus muscle superficial to its deep fascia .
In group O: (n=26) every patient will receive unilateral anterior obturator nerve block combined to adductor canal block, The anterior branch of the obturator nerve is seen in the proximal thigh medial to the femoral vessels between the adductor longus and adductor brevis below the inguinal crease. The same 21-gauge 90 mm needle will be directed through the adductor longus in an out of plane technique. A small volume of dextrose 5%, (1-2 ml) will be injected to ensure the needle tip is positioned between the two muscles. After negative aspiration, bupivacaine 0.25%, 10 ml will be injected in this muscle plane to surround the anterior division of obturator nerve.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group C: will receive unilateral adductor canal block alone | Active comparator | Procedure: adductor canal block |
| group H:will receive unilateral peri-hamstring injection combined to adductor canal block | Active comparator | Procedure: adductor canal block |
| group O: will receive unilateral anterior obturator nerve block combined to adductor canal block | Active comparator | Procedure: adductor canal block |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21-70 years
- Both sex
- Patients scheduled for elective arthroscopic anterior cruciate ligament reconstruction under general anesthesia.
- American Society of Anesthesiologists Physical Status Class I, II Patients.
- Body Mass Index <30 kg/m2.
Key exclusion criteria (12 listed)
- History of allergy to the study medications.
- American Society of Anesthesiologists class ≥III.
- Patients refusal to participate in the study.
- The inability to comprehend or participate in the pain scoring system.
- Contraindications to regional anesthesia (including coagulopathy and local infection).
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 blockAlso: obturator canal block, peri-hamestring injectiongroup C will receive a unilateral adductor canal block alone, using an ultrasound to identify the location of the nerve. group H will receive unilateral peri-hamstring injection combined to adductor canal block, After the adductor canal block, the transducer will be moved posteriorly till identifying the site of injection group O will receive unilateral anterior obturator nerve block combined with adductor canal block, The anterior branch of the obturator nerve is located using ultrasound | Procedure or surgery | group C: will receive unilateral adductor canal block alone, group H:will receive unilateral peri-hamstring injection combined to adductor canal block, group O: will receive unilateral anterior obturator nerve block combined to adductor canal block |
Primary outcome
post operative pain control
Time frame: 6 hours
The postoperative visual analogue scale pain score.( from 0 to 10, 0 being "no pain" and 10 being "worst possible pain." )
6 secondary outcomes
pain controlling methods
Time frame: 24 hours
pain controlling methods
Time frame: 24 hours
pain controlling methods
Time frame: 24 hours
pain controlling methods
Time frame: 24 hours
pain controlling methods
Time frame: 24 hours
pain controlling methods
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing adductor canal block in people with Adductor Canal Block, run by Ain Shams 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 5 inclusion and 12 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 3 May 2024. 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 Mohamed Ibrahim El-Desoukey, Master degree (0201064988842, mohamed.i.eldesoukey@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain control (time frame: 6 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 3 May 2024.