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Intervention model description: The patients were randomly classified into three groups using computer-generated table numbers each contain (25) patients.
Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D): 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine Control group (group C): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. Masking: double-blind (participant and investigator) Masking Description: The investigator's study is a prospective, randomized, double-blind
This randomized, prospective, double-blind study was carried out on 75 ASA Physical Status I-II adults aged 18-75 years old scheduled to undergo elective and emergency forearm and hand surgeries under ultrasound-guided supraclavicular brachial plexus block. After obtaining the local ethics committee of El-Minia university hospital approval and written informed consent was taken of the patient, this study was conducted from April 2019 to February 2020 in El-Minia university hospital. The investigators excluded any patient with bleeding disorders, damage or disease of the brachial plexus, uncontrolled diabetes mellitus, and patients with neuromuscular diseases, Patients with a local skin infection at the site of injection or patients with known hypersensitivity to studied drugs.
Preoperative assessment and preparation: A careful assessment of medical history, general examination including chest, heart, abdomen, site of injection and other systems were carried out. Routine investigations were done as complete blood picture, ECG (electrocardiogram) renal and liver functions. An explanation of the visual analog scale was done to each patient.
Preparation of the studied medications: The patients were randomly classified into three groups using computer-generated table numbers each contains (25) patients. Ketamine group (group K): 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine, Dexmedetomidine group (group D) 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine (precedex® Hospira,Inc., Lake Forest USA).
Control group (group C) 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline. All medications were prepared in similar sterile coated bottles by the supervisor who didn't include in the anesthetic or operative team, 75 bottles numbered from 1 to 75 were prepared. After completion of the study, the key was opened by the supervisor Block technique: On patient's arrival to the operating room, a 20 G intravenous cannula was inserted in a peripheral vein of unaffected limb and standard monitoring commenced as noninvasive blood pressure (NIBP), (ECG), and Oxygen saturation (Spo2) (UltraviewSL2700, Spacelaps, USA), all equipment and drugs for general anesthesia and resuscitation were prepared, the ultrasound device (Sonosite, Nanomax, USA ) lubricating gel, 21guge 50 mm length, short bevel, insulated stimulating needle (Laboratoires pharmaceutiques, Vygon, France). Patient lie supine with the head turned to the other side and ipsilateral arm adducted gently with a flexed elbow. Under the complete aseptic condition, the identified area and the ultrasound probe was prepared with anti-septic (Povidone-Iodine 10%) solution and the skin infiltrated with 1-2 ml of lidocaine 2% solution subcutaneously, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the supraclavicular brachial plexus was seen, it either appeared as a grape-like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region or as 3 hypoechoic circles with hyperechoic outer rings, the predetermined volume of 40 mL of the study drug solution was administered around the brachial plexus after negative aspiration to avoid accidental intravascular injection, expansion of the brachial plexus sheath was considered as an indication of correct needle placement, multiple injections were used to deposit the total amount of the study drugs, skin massage for about 3 minutes was done to facilitate drug distribution.
Parameters assessed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline |
|
| Ketamine group | Active Comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5%bupivacaine and 20 ml 0.9% normal saline plus 1 mg\kg ketamine |
|
| Dexmedetomidine group | Active Comparator | Supraclavicular Brachial Plexus Block using 20 ml 0.5% bupivacaine and 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supraclavicular Brachial Plexus Block with bupivacaine | Drug | drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate duration of sensory block | Sensory block duration: the time interval between the complete sensory block and complete resolution by hours | 24 hours after block |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate onset of sensory and motor block | Onset time for sensory and motor block: the time interval between the end of local anesthetic administration and complete sensory and motor block by min. | 30 minute after block |
| Assess postoperative pain score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haidy S Mansour, MD | assistant professor of Anesthesia and Surgical Intensive Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minya University | Minya | 61519 | Egypt |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 21, 2019 | Aug 7, 2020 |
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| Supraclavicular Brachial Plexus Block with Ketamine | Drug | drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block |
|
|
| Supraclavicular Brachial Plexus Block with Dexmedetomidine | Drug | drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4. Device: ultrasound-guided supraclavicular Brachial Plexus nerve block |
|
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The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAP) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain |
| For 24 hours after surgery |
| time to first analgesic request | Time for the first request to rescue analgesia (in hours) | 24 hours |
| total analgesic requirements | Total diclofenac consumption requirements in 24 hours | 24 hours after surgery |
| sedation score | Ramsay Sedation Scale from 1-6 as follows: 1 = anxious, agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responds to commands only; 4 = brisk response to light glabellar tap or loud noise; 5 =sluggish response; 6 = no response | 24 hours after surgery |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D007649 | Ketamine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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