Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04892420 |
| Other study ID # |
R 87/2021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 9, 2021 |
| Est. completion date |
October 30, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Ain Shams University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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.
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.
B. 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.
C. 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.
