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AnesthesiaPhase 2NCT04892420

Comparison Between Adjuvants Added to Bupivacaine in Adductor Canal Block

A Phase 2 study testing Dexamethasone, Dexmedetomidine and Magnesium sulfate in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Adult patients undergoing anterior cruciate ligament repair under Spinal Anaesthesia will be randomly assigned into one of the following groups (The Four study groups will receive the standard treatment in the form of spinal anesthesia and adductor canal block), using computer generated codes and opaque sealed… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Anesthesia
What is being tested?
Dexamethasone, Dexmedetomidine and Magnesium sulfate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteEgypt
Study dates
9 Jun 2021to 30 Oct 2021
Phase
Phase 2
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 18-60 years.
  • Sex: Both sexes.
  • Height 155-170 cm.
  • American Society of Anaesthesiologists (ASA) Physical Status Class-I and II.
  • Scheduled for anterior cruciate ligament under spinal anaesthesia.

Who cannot join

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorder.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ismail Mohammed Ibrahim

    Cairo, 11591

Other trials in Egypt

About this study

Official title: The Effect of Adding Dexamethasone Versus Magnesium Sulphate Versus Dexmedetomidine to Bupivacaine in Ultrasound Guided Adductor Canal Block for Post-operative Analgesia Following Anterior Cruciate Ligament Repair

Adult patients undergoing anterior cruciate ligament repair under Spinal Anaesthesia will be randomly assigned into one of the following groups (The Four study groups will receive the standard treatment in the form of spinal anesthesia and adductor canal block), using computer generated codes and opaque sealed envelopes:

  1. Group DX(DEXAMETHASONE): The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anaetthesia.
  2. Group DM (dexmedetomidine)The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anaetthesia.
  3. Group M (magnesium sulphate):The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anaetthesia.
  4. Group C(CONTROL): The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anaetthesia.
Read the detailed description

All patients will clinically be assessed and routine preoperative investigations will be done; CBC, Coagulation profile, liver function tests, kidney function tests, fasting blood sugar and ECG.

  1. Intraoperative settings:

On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied.

Baseline parameters such as systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), and oxygen saturation (SpO2) will be also recorded, All patients in this study will be positioned similarly during the entire surgical procedure and the whole procedures will be done by the same team.

Intravenous (IV) line will be inserted, and IV lactated Ringer will be started.

For all groups, spinal anaesthesia will be performed using spinal needle of 25-G under complete aseptic conditions All participants will receive spinal anaesthesia using hyperbaric 0.5% bupivacaine 20 mg and fentanyl 25 µg.

ACB will be done in the study at the end of surgery.

Specific equipment required: 22-gauge 100mm length, short-beveled regional block needle, skin antiseptic solution, sterile gloves, the portable ultrasound machine.

In Group DX:

The patients received 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) Position patient supine with knee slightly flexed and leg externally rotated

  • Cleaning the area with Povidone-iodine 10% (Betadine), stand to the side of the patient to be blocked with the ultrasound machine on the opposite side and the screen facing, placing a high frequency ultrasound probe on the anterior aspect of the patient's thigh, approximately mid-point between the inguinal crease and medial condyle, Identifying the femur (usually at a depth of 3-5cm although variable) and move probe medially until the trapezoid/boat shaped Sartorius' muscle is visualized. The femoral artery lies just under this muscle within the adductor canal. Considering the saphenous nerve is almost always too small to be reliably imaged and the aim of the technique is therefore, to deposit local anesthetic under Sartorius and around the femoral artery (i.e. within the adductor canal).
  • Optimizing image, adjusting depth, gain and frequency settings as required, the appropriate probe position is just proximal to where the femoral artery "dives" posteriorly and the probe should be positioned perpendicular to the artery. At this point the femoral artery should start to pass deeper to form the popliteal artery, the vastus medialis muscle lies anterolateral, the adductor magnus muscle posteromedial and the sartorius muscle medial. Use an in-plane approach from lateral to medial ensuring that your needle tip can be seen at all times, advance your needle into the adductor canal. This can be achieved by traversing Sartorius or Vastus Medialis, Aspirate and inject a test dose of 1 ml of the local anesthetic solution, observe the spread of the local anesthetic to ensure your needle tip is definitely within the adductor canal. If you cannot clearly see the spread of local anesthetic consider intravascular placement of needle and reposition, continue with the injection, aspirating every 5mls. 2-In GROUP DM: 25 microgram dexmedetomidine will be Added. 3-IN GROUP M: 200 milligram magnesium sulphate will be added 4-IN GROUP C (CONTROL): Nothing will be added to bupivacaine.
  1. Postoperative settings:

After the patient will be discharged from the operating room. Visual analog scale (VAS) will be used to assess the postoperative pain;

  • The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a hand written mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm), and an eight-point verbal rating score for pain at rest (no pain _ 0, just noticeable _ 1, mild _ 2, weak _ 3, moderate _ 4, strong _ 5, severe _ 6,excruciating _ 7, same random word display shown to each patient).
  • If VAS ≥ 3 postoperatively, IV increment of morphine will be given 0.1 mg per Kg not to be repeated every less than 3 hours ,The times of the first request for postoperative analgesia and the number of injections will be recorded. Any side effects will be recorded as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <60 beat/min), nausea or vomiting, or any other complications. Atropine 0.5 mg will be given in response to bradycardia, 20 ml per kg lactated Ringer will be given in response to hypotension.
  • If local anaesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 100 ml over 2-3 min will be given.
  • HR and MBP will be measured upon arrival to the PACU and after 30 min, then every hour if the patients remain in the PACU.
  • In the surgical ward, vital signs (HR, SBP, MBP, DBP) as well as pain intensity will be assessed every 2 hours during the first 6 hours and then every 6 hours there for 24 hours postoperatively. All patients will receive ketorolac 30 mg IM every 8h. It will start immediately postoperatively in the PACU.

Measurements;

● Primary outcome:

VAS for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours there for 24 hours postoperatively

Duration of postoperative analgesia (the time from recovery to the first given dose of morphine)

Number of patients needed rescue analgesia.

● Secondary outcome:

The total dose of morphine used postoperatively/patient (rescue analgesia) for 24 h.

Conditions
Anesthesia
Being tested
Dexamethasone, Dexmedetomidine, Magnesium sulfate, Bupivacain
Keywords
dexamethasone,, magnesium sulphate, dexmedetomidine, adductor canal block, anterior cruciate ligament repair

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called decadrone

    The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia.

  • DexmedetomidineDrug

    Also called precedex

    The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .

  • Magnesium sulfateDrug

    Also called english salt

    The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.

  • BupivacainDrug

    Also called marcain

    The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.

Study groups in NCT04892420
Study groupRoleWhat they receive
Group DXActive comparatorThe patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia
Receives: Drug: Dexamethasone
Group DMActive comparatorThe patients receive 20 ml plain bupivacaine(0.5%)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .
Receives: Drug: Dexmedetomidine
Group MActive comparatorThe patients receive 20 ml plain bupivacaine(0.5%)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.
Receives: Drug: Magnesium sulfate
Group CPlacebo comparatorThe patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.
Receives: Drug: Bupivacain

What is being measured

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

  1. rescue analgesia time

    time to first analgesic requirement

    Measured: first 24 hours postoperatively

Secondary outcomes (1)
  1. rescue analgesia

    total dose of morphine needed postoperatively

    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 posted19 May 2021
  2. Study start9 Jun 2021
  3. Primary completion20 Aug 2021
  4. Study completion30 Oct 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892420
Sponsor's protocol ID
R 87/2021
Status last verified
Jan 2022
First submitted
11 May 2021
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Dexmedetomidine and Magnesium sulfate in people with Anesthesia, run by Ain Shams 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 5 inclusion and 4 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 25 Jan 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

rescue analgesia time (time frame: first 24 hours postoperatively). 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 25 Jan 2022.

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