Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in IVRA

Assiut University

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain

Treatments: Drug: Lidocaine; Drug: Mg sulphate; Drug: atracurium

Study type: Interventional

Funder types: Other

Identifiers

NCT02920905

Li,atr,mg in ivra

Details and patient eligibility

About

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 .

Full 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

Enrollment: 75 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Short procedures (less than 2 hours).
• Cooperative patients.

Exclusion criteria

• 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 .

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

lidocaine

Experimental group

Description:

• Patients in group A will receive 3 mg/kg of lidocaine 2% diluted with saline to a total volume of 40 ml.

Treatment:

Drug: Lidocaine

lidocaine & atracurium

Experimental group

Description:

• Patients in group B receive 3 mg/kg of lidocaine 2% + 2 mg atracurium diluted with saline to a total volume of 40 ml.

Treatment:

Drug: atracurium

Drug: Lidocaine

lidocaine & atracurium & Mg sulphate

Experimental group

Description:

• 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.

Treatment:

Drug: atracurium

Drug: Lidocaine

Drug: Mg sulphate