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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Mohamed Ibrahim El-Desoukey, Master degree contact

0201064988842

mohamed.i.eldesoukey@med.asu.edu.eg

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.

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 groups in NCT06398717
Study groupRoleWhat they receive
group C: will receive unilateral adductor canal block aloneActive comparatorNot described
Receives: Procedure: adductor canal block
group H:will receive unilateral peri-hamstring injection combined to adductor canal blockActive comparatorNot described
Receives: Procedure: adductor canal block
group O: will receive unilateral anterior obturator nerve block combined to adductor canal blockActive comparatorNot described
Receives: Procedure: adductor canal block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  1. 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

  2. pain controlling methods

    The total consumption of rescue analgesia in 24 hours.

    Measured: 24 hours

  3. pain controlling methods

    The total number of patients who received intraoperative fentanyl.

    Measured: 24 hours

  4. pain controlling methods

    The total number of patients who needed rescue analgesia.

    Measured: 24 hours

  5. pain controlling methods

    The occurrence and severity of complications were noted postoperatively.

    Measured: 24 hours

  6. 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.

  1. First posted3 May 2024
  2. Study start1 May 2024 (estimated)
  3. Primary completion1 Nov 2024 (estimated)
  4. Study completion31 Jan 2025 (estimated)

Resources

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)
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

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.

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