CClinicalTrials.gg
Not yet recruitingNCT06398717Updated May 3, 2024

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

An interventional study of adductor canal block in Adductor Canal Block, sponsored by Ain Shams University. Not yet recruiting. Open to participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-03.

Sponsored by Ain Shams University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Adductor Canal Block
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Age 21-70 years
  2. Both sex
  3. Patients scheduled for elective arthroscopic anterior cruciate ligament reconstruction under general anesthesia.
  4. American Society of Anesthesiologists Physical Status Class I, II Patients.
  5. Body Mass Index \<30 kg/m2.

Exclusion criteria

Exclusion Criteria:

  1. History of allergy to the study medications.
  2. American Society of Anesthesiologists class ≥III.
  3. Patients refusal to participate in the study.
  4. The inability to comprehend or participate in the pain scoring system.
  5. Contraindications to regional anesthesia (including coagulopathy and local infection).
  6. Psychiatric disorder and patient with any neurological disorder.
  7. Opioid tolerance or dependence.
  8. Distorted anatomy.
  9. Peripheral neuropathy.
  10. Renal or hepatic impairment.
  11. Morbid obesity (Body Mass Index: >30kg/m2).

    -

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Active comparator
    group C: will receive unilateral adductor canal block alone

    Procedure: adductor canal block

  • Active comparator
    group H:will receive unilateral peri-hamstring injection combined to adductor canal block

    Procedure: adductor canal block

  • Active comparator
    group O: will receive unilateral anterior obturator nerve block combined to adductor canal block

    Procedure: adductor canal block

Interventions

  • Procedureadductor canal block

    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

    Also known as: obturator canal block, peri-hamestring injection

06

What researchers measure

Primary outcomes

  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." )

    Time frame: 6 hours

Secondary outcomes

  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))

    Time frame: 24 hours

  2. pain controlling methods

    The total consumption of rescue analgesia in 24 hours.

    Time frame: 24 hours

  3. pain controlling methods

    The total number of patients who received intraoperative fentanyl.

    Time frame: 24 hours

  4. pain controlling methods

    The total number of patients who needed rescue analgesia.

    Time frame: 24 hours

  5. pain controlling methods

    The occurrence and severity of complications were noted postoperatively.

    Time frame: 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))

    Time frame: 24 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06398717
Lead sponsor
Ain Shams University
Responsible party
Mohamed Ibrahim El-Desoukey (assistant lecturer, Ain Shams University) — Principal investigator
First posted
May 3, 2024
Start date
May 1, 2024 (estimated)
Primary completion
Nov 1, 2024 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
May 3, 2024

Study contacts

Mohamed Ibrahim El-Desoukey, Master degree
Contact
mohamed.i.eldesoukey@med.asu.edu.eg
0201064988842

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion