Efficacy of Dexmedetomidine, Dexamethasone, and Magnesium Sulphate as Adjuvants in Ultrasound-guided Supraclavicular Brachial Plexus Block in Forearm Surgeries - A Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Al-Azhar University
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- -Post operative Visual analogue scale VAS score
Overview
Brief Summary
This study is to evaluate whether addition of dexmedetomidine, dexamethasone and magnesium sulfate as adjuvants to bupivacaine in supraclavicular Brachial Plexus Blockade (BPB) for pain management assessed by VAS score.
Detailed Description
This is a randomized controlled study involving 105 participants divided into three groups to assess the efficacy of adding dexmedetomidine, dexamethasone, and magnesium sulfate as adjuvants to bupivacaine in supraclavicular brachial plexus blockade during upper limb surgeries. The primary outcome is the postoperative Visual Analog Scale (VAS) score. The secondary outcomes are assessment of onset and duration of the block, patient satisfaction, and adverse effects.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) status of I and II
- •undergoing forearm surgeries
Exclusion Criteria
- •coagulopathies
- •Local skin lesions
- •Pregnancy
- •Has a history of significant neurological, psychiatric, or neuromuscular disorders
- •Patients refusing participation
- •BMI \> 40
- •Patient with COPD. hypersensitivity or allergies to local anesthesia
Outcomes
Primary Outcomes
-Post operative Visual analogue scale VAS score
Time Frame: Over 24 hours post operative starting from transeferring the patient to the recovery area.
Assess post-operative VAS score at: T0 (after transferring to the recovery area), at T1: at two hours, T3: at four hours, T4: at six hours, T5: at eight hours, T6: at 10 hours, T7: at 12 hours, T8: at 16 hours, T9: at 20 hours, and T10 at 24 hours postoperatively.
Secondary Outcomes
- Postoperative transient neurologic symptoms(Over 48 hours post operative starting from transeferring to the recovery area.)
- Onst of sensory block(Complete sensory block will be assessed every 5 min up to a maximum of 30 minutes)
- Onset of motor block(Complete motor block will be assessed every 5 min up to a maximum of 30 minutes)
- Duration of the sensory block(Sensation will be assessed every 4 hours till return of normal sensation up to maximum 24 hours .)
- duration of the motor block(Motor power will be assessed every 4 hours till return of normal sensation up to maximum 24 hourswill be assessed every 4 hours till return of normal sensation up to maximum 24 hours)
- Intraoperative mean arterial blood pressure(From positioning the patient to the block upto 90 minutes from removing the needle)
- Intraoperative Pulse rate.(From positioning the patient to the block upto 90 minutes from removing the needle)
- Post operative opioid consumption(Over 24 hours post operatively started form transferring the patient to the recovery area)
- Post operative Nausea and vomiting(Over 24 hours post operative starting from transferring to the recovery area.)
Investigators
Mohammed Gaber Saad
Lecturer of anesthesia, Intensive care and pain management.
Al-Azhar University