Ismail Mohammed Ibrahim
Cairo, 11591, Egypt
NCT Number: NCT04892420
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 2
Cairo, 11591, Egypt
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
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;
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia.
Other names: decadrone
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 .
Other names: precedex
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.
Other names: english salt
The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.
Other names: marcain
Time frame: first 24 hours postoperatively
time to first analgesic requirement
Time frame: 24 hours
total dose of morphine needed postoperatively
Ain Shams University
Other
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
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