Efficacy and Safety of Dexmedetomidine to Bupivacaine in Supraclavicular Brachial Plexus Block
- Conditions
- DexmedetomidineBupivacaineSupraclavicular Brachial Plexus Block
- Interventions
- Registration Number
- NCT06020781
- Lead Sponsor
- Kafrelsheikh University
- Brief Summary
The study aims to evaluate the analgesic efficacy and safety of addition of 1µg/kg dexmedetomidine to 20ml bupivacaine compared to 20ml and 30ml bupivacaine without additives in ultrasound-guided supraclavicular brachial plexus block for anesthesia.
- Detailed Description
Dexmedetomidine, a highly selective α2 adrenergic agonist, has been used as an adjuvant to local anesthetics. Various clinical trials performed have shown dexmedetomidine to be safe when used as an adjuvant to local anesthetic in subarachnoid, caudal, and epidural Different doses of dexmedetomidine are commonly used as an additive in Ultrasound-guided supraclavicular brachial plexus block, 1 μg/kg and 2 μg/kg in which a high dose of dexmedetomidine does not prolong the duration of analgesia, but it is associated with lower heart rate and blood pressure. Incidence of hypotension and bradycardia is also more. Hence, a lower dose of 1 μg/kg dexmedetomidine is a good balance between safety and efficacy
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- American Society of Anesthesiologist (ASA) grade I or II patients
- both sexes
- scheduled for elective upper limb surgery below mid-humerus level under Ultrasound -guided Supraclavicular brachial plexus block .
- with pre-existing peripheral neuropathy of upper limb.
- Bleeding disorders.
- Infection at injection site.
- Untreated pneumothorax.
- Patients on adrenoreceptor agonist or antagonist therapy.
- History of severe cardiac,.respiratory, hepatic, or renal disease.
- pregnancy and known hypersensitivity to the study drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine and Dexmedetomidine bupivacaine and dexmedetomidine. Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% + 1 μg/kg dexmedetomidine. 20 ml Bupivacaine without additives bupivacaine only Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 20 ml bupivacaine 0.5% without additives. 30 ml bupivacaine without additives bupivacaine Patients will receive ultrasound-guided Supraclavicular brachial plexus block with 30 ml bupivacaine 0.5% without additives as a control group.
- Primary Outcome Measures
Name Time Method Success rate. 30 minutes after block performance Sensory and motor block evaluation will be done every 3 min after giving the block until complete sensory and motor block or 30 min, whichever will be earlier.
- Secondary Outcome Measures
Name Time Method Total pethidine consumption. 24 hours postoperative. Visual analog scale ≥ 4 indicates the analgesic requirements. The patient will be given supplementary pethidine I.V. injection in a dose of 0.5 mg as rescue analgesia. Total pethidine consumption postoperative in the 1st 24 hours will be measured.
Pain score. 24 hours postoperative. Pain score will be measured by visual analogue scale (VAS) at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative.
The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).Mean arterial blood pressure From preoperatively till the end of surgery Mean arterial blood pressure from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.
Heart rate From preoperatively till the end of surgery Heart rate from preoperatively, after block, then every 15 minutes intraoperative till the end of surgery.
Postoperative side effects. 24 hours postoperative Complication related to the block or adverse events of the administered drugs.
Trial Locations
- Locations (1)
Kafrelsheikh University
🇪🇬Kafr Ash Shaykh, Kafrelsheikh, Egypt