Neostigmine and Dexamethasone in Adductor Canal Block

Study Overview
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Brief Summary
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To compare between the efficacy of neostigmine and dexamethasone as an adjuvant to bupivacaine in adductor canal block after knee arthroscopy surgery.

Detailed Description
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90 participants in this study will be randomized into three groups based on computer generated numbers using computerized generated random tables. The patients enrolled in the study will be transferred to the operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG. To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (25G) will be introduced to the intrathecal space and after ensuring that clear cere¬brospinal fluid will be in free flow injection of 15-20mg of bupivacaine 0.5% and 25mcg of fentanyl will be administrated then the patient will be positioned in the supine position. If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 9mg intravenous ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50beat / minute) occurs, 0.5mg intravenous atropine will be given. After the surgical procedure the patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are: Group neostigmine: The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block. Group dexamethasone: The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block. Group control: The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group). With the patient in the supine position, the procedural needle (Braun Stimuplex Ultra Insuflated Echogenic Needle 22G) will be inserted in plane from the anteromedial side at the mid thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle tip will be located in the adductor canal, the anaesthetic solution will be injected anterior to the artery and deep into the sartorius muscle (24) then patient will be transferred to the PACU then to the ward. Postoperative Postoperative pain will be assessed by visual analog scale (VAS) A fixed dose of intravenous paracetamol 1 gram will be given every 6 hours to all patients in the three groups starting from 1 hour after the ACB. Postoperative pain assessment through VAS will be according to the scale as follow: Pain level 0: no pain Pain level1-3: mild pain Pain level 4-6: moderate pain Pain level 7-10: severe pain Postoperative pain will be managed as follow: Mild pain will be treated with ketolac 30mg IV. Moderate pain will be treated with ketolac 30mg IV + morphine 0.07mg/kg IV. Severe pain will be treated with ketolac 30mg IV & morphine 0.1mg/kg IV. Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS. Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansterone (4mg IV).

Official Title
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A Comparative Study Between Neostigmine and Dexamethasone as an Adjuvant to Bupivacaine in Adductor Canal Block After Knee Arthroscopy Surgery

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: neostigmine
* Other: NaCl solutions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing knee arthroscopy surgery. Age between 18 years and 65 years. Both sexes ASA I & ASA II Exclusion Criteria: Patients' refusal Allergy to any drug that will be used in the study Psychological or mental disorders. Disturbance of Conscious level. Uncooperative patients Coagulopathy Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>The patients in this group will be administered 2 ml isotonic saline + 20 ml bupivacaine 0.50 % in the adductor canal block (control group). | Other: NaCl solutions<br>* adductor canal block<br>* Other names: normal saline;|
| Active Comparator: Group D<br>The patients in this group will be administered 8 mg dexamethasone (2 ml) (23) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block. | Drug: Dexamethasone<br>* adductor canal block<br>* Other names: Decadron;|
| Active Comparator: Group N<br>The patients in this group will be administered 500 mcg neostigmine (1 ml) + 1 ml isotonic saline (22) as adjuvant to 20 ml bupivacaine 0.50 % in the adductor canal block. | Drug: neostigmine<br>* adductor canal block<br>* Other names: prostigmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first rescue analgesia time | Time (in hours) of first rescue analgesia (morphine) requirement for each group in the first 24 hours following the adductor canal block | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morphine consumption | Total amount of morphine consumed in the first 24 hours following the AC | 24 hours | 
| Visual analogue scale | VAS score at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively. As visual analouge scale (VAS) is a scale from 0 to 10 where 0 means no pain and 10 means the most severe pain. | up to 24 hours | 
| sensory block | Duration of sensory block at times 0-30 minutes, 1, 2, 4, 8, 12, 18 and 24 hours postoperatively | up to 24 hours | 
| Presence of Nausea and vomiting | through a question answered by yes or no to identify the presence of nausea and vomiting | 24 hours |