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

Postoperative Pain Clinical Trial

Official title:

Atracurium Mixed With Magnesium Sulfate Versus Atracurium Alone as Adjuvant to Lidocaine in Intravenous Regional Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920905
• Other study ID #: Li,atr,mg in ivra
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: April 2017

Study information

• Verified date: June 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Lidocaine
Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min. Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.
• atracurium
Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min. Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.
• Mg sulphate
Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min. Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse . The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative analgesia	postoperative analgesia measured by VAS of 0-10 (0= no pain and 10=Worst pain imaginable ) during the first 24 hours	24 hour
Secondary	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	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.	24 hours