Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA
- Conditions
- Postoperative Pain
- Interventions
- Registration Number
- NCT02920905
- Lead Sponsor
- Assiut University
- Brief Summary
The present clinical study will be undertaken to compare study between the effect of atracurium with lidocaine versus addition of magnesium sulphate to the same doses with lidocaine administrated alone in IntraVenous Regional Anaesthesia to access motor block, sensory block, tourniquet pain and post operative analgesia .Also assessment of patient and surgeon satisfaction .
- Detailed Description
patients will be divided randomly into three groups (A, B, C) of 25 each, according to computer generated table of random numbers.
* Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.
* Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml.
* Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml.
Onset of sensory block will be assessed by a pin prick performed at 1 minute interval in the dermatomal sensory distribution of the medial and lateral ante brachial cutaneous, ulnar, median and radial nerves. Sensory block onset time will be recorded as time elapsed from injection of drug to sensory block achieved in all dermatomes.Onset of motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers. Monitoring of motor block will be assessed by Modified Bromage Score . Complete motor block will be recorded when no voluntary movement will be possible.
At the end of surgery, the tourniquet will be deflated by a cyclic deflation technique and recording this :
* Sensory block recovery time
* Motor block recovery time
* Mean arterial pressure (MAP),
* heart rate (HR)
* visual analogue scale (VAS) will be recorded at 0, 15 min , 1, 6, 12, and 24 h.
* The time to first analgesic requirement will be recorded (the time elapsed from tourniquet release until first patient request for analgesic).
Patient and surgeon satisfaction
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 75
- Short procedures (less than 2 hours).
- Cooperative patients.
- Patients with sickle cell anemia.
- History of drug allergy.
- Raynaud's disease.
- Scleroderma.
- Myasthenia gravis.
- Cardiac disease.
- Diabetes mellitus.
- Peptic ulcer.
- Gastritis.
- Liver or renal insufficiency.
- Patients with history of convulsions .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description lidocaine & atracurium & Mg sulphate Mg sulphate • Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml. lidocaine Lidocaine • Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml. lidocaine & atracurium atracurium • Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml. lidocaine & atracurium Lidocaine • Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml. lidocaine & atracurium & Mg sulphate Lidocaine • Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml. lidocaine & atracurium & Mg sulphate atracurium • Patients in group C will receive 3 mg/kg of lidocaine 2% + 2 mg atracurium mixed with 10 mg /kg magnesium sulphate diluted with saline to a total volume of 40 ml.
- Primary Outcome Measures
Name Time Method postoperative analgesia 24 hour postoperative analgesia measured by VAS of 0-10 (0= no pain and 10=Worst pain imaginable ) during the first 24 hours
- Secondary Outcome Measures
Name Time Method The onset and recovary times of sensory and motor block , first analgesic request , tourniquet pain ,side effects of study drugs , and quality of anesthesia assessed by patients and surgeons 24 hours Onset of sensory block assessed by pinbrick of the arm . Onset of motor block will be assessed by asking the subject to flex and extend his/her wrist and fingers. Monitoring of motor block will be assessed by Modified Bromage Score . Complete motor block will be recorded when no voluntary movement will be possible.
Trial Locations
- Locations (1)
Assiut University Hospital
🇪🇬Assiut, Egypt