Forearm Clinical Trial
Official title:
Ultrasound Guided Infraclavicular Brachial Plexus Block Using Levo-bupivacaine Alone or Combined With Dexmedetomidine for Hand and Forearm Surgeries
Verified date | January 2021 |
Source | Aswan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries as regard: Onset of sensory and motor blockade. Duration of sensory and motor blockade. Analgesic pain scores using the verbal rating scale (VRS) for pain. Duration of analgesia postoperative complications.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 1, 2020 |
Est. primary completion date | April 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age: 20-65 years old. - American society of anesthesiologist physical status (ASA): I-II. - Operation: forearm & hand surgeries. Exclusion Criteria: - Patients with chronic pain - Those using chronic analgesic medications - History of brachial plexus injury - Allergy to the study drugs - Hepatic or renal insufficiency or infection at the site of injection |
Country | Name | City | State |
---|---|---|---|
Egypt | Zaher | Cairo |
Lead Sponsor | Collaborator |
---|---|
Aswan University Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Onset time of sensory block in minutes | After the injection of the solution, every patient was checked for the onset of sensory blockade using goose soaked with iced normal saline by the following scale (three-point scale): Grade 0= perceived as normal sensation, Grade 1 = loss of cold sensation (analgesia), Grade 2= loss of sensation of touch (anesthesia). | 45 minutes | |
Primary | onset time of motor blockade in minutes using the modified Bromage scale (Three-point scale) | the modified Bromage scale (Three-point scale): Grade 0: Normal motor function, Grade 1: Decreased motor strength with the ability to move the fingers only, Grade 2: Complete motor block with an inability to move the fingers. | 24 hours | |
Primary | Duration of sensory block in hours | It's the time from sensory block onset to the time of restoration of sensation at the surgical site | 24 hours | |
Primary | Duration of motor block in hours | It's the time from motor block onset to the restoration of global mobility in the hand and the wrist. | 24 hours | |
Secondary | Visual analog scale (VAS) | the VAS consisted of a straight, vertical 10-cm line; the bottom point represented "no pain" = (0 cm) and the top "the worst pain you ever have" = (10 cm) | 24 hours | |
Secondary | Postoperative first analgesic request time in hours | was taken from the time of complete sensory block to the request to rescue analgesia when VAS > 4 cm. | 24 hours | |
Secondary | Mean blood pressure in mmHg | was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block | 24 hours | |
Secondary | heart rate in beats / minute | was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block. | 24 hours | |
Secondary | peripheral oxygen saturation | was measured before the block (0 min) and at 5, 10, 15, 30 min then 1, 2, 3, 6, 12,18and 24 h after the block. | 24 hours |
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