COMPARISON OF TWO LOCAL ANAESTHETIC DRUGS (ROPIVACAINE AND LEVOBUPIVACAINE) FOR NERVE BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERY

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/09/036773
• Lead Sponsor: ABVIMS AND DRRML HOSPITAL

Brief Summary

**AIM**: To compare the duration of sensory and motor blockade with Ropivacaine and Levobupivacaine in Ultrasound guided Supraclavicular brachial plexus block for upper limb surgeries.

**PRIMARY OBJECTIVE**: To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries.



**SECONDARY OBJECTIVE**:To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups.



**METHODOLOGY**

After a detailed pre-anaesthetic check-up, an informed consent will be obtained from all the patients after explaining the details of the procedure. In the operation theatre, pre-operative parameters including heart rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and oxygen saturation (SpO2) will be recorded and an intravenous access established and iv fluids started. Patients will be sedated with intravenous Midazolam 0.03 mg/kg, supra-clavicular brachial plexus block will then be performed .



**SUPRA-CLAVICULAR BRACHIAL PLEXUS BLOCK**



**Position**: This block will be performed with the patient in the supine position, with the patient’s head turned away from the side to be blocked.



**USG guided Technique:**After sterile preparation and draping, the transducer is positioned in the transverse plane immediately proximal to the clavicle, slightly posterior to at its midpoint. The transducer is tilted caudally, as if to image the chest contents, to obtain a cross-sectional view of the subclavian artery. The brachial plexus is seen as a collection of hypoechoic oval structures posterior and superficial to the artery. Colour Doppler should be routinely used prior to needle insertion to rule out the passage of large vessels (i.e., dorsal scapular artery, transverse cervical artery, suprascapular artery) in the anticipated trajectory of the needle.Using a 25-gauge needle, 1–2 mL of local anesthetic is injected into the skin 1 cm lateral to the transducer to decrease discomfort during needle insertion. The block needle is then inserted in plane toward the brachial plexus, in a lateral-to-medial direction. After careful aspiration, 1–2 mL of normal saline is injected to confirm proper needle placement. When the injection displaces the brachial plexus away from the needle, an additional advancement of the needle 1–2 mm closer to the plexus may be required to accomplish adequate local anesthetic spread.



After proper needle placement:

Group 1 – Patients will receive 30 ml of 0.5% ropivacaine with 25 µg Fentanyl (n=21)

Group 2 – Patients will receive 30 ml of 0.5% levobupivacaine with 25 µg Fentanyl (n=21) Surgical anaesthesia will be achieved when the patient shows complete loss of sensation in the surgical field with the concomitant inability to elevate the operated limb.



**OBSERVATION**:The following observations will be made:

• **Time of onset of sensory block** : the time from the completion of the injection of drug till the patient can no longer feel the cold sensation in the surgical field by the Ice test method.

• **Time of onset of motor block** : the time from the completion of the injection of drug till the complete block i.e. Modified Bromage scale of 3.

• ECG and SpO2 will be monitored continuously throughout the surgery.

• HR, SBP, DBP, MAP will be recorded every 5 mins for the first 15 mins and thereafter every 15 mins throughout the surgery.

• Duration of sensory and motor blockade will be assessed every hour till the recovery.

• Duration of sensory block will be defined as time from the loss of temperature sensation till the recovery of sensation (by Ice test method).

• Duration of motor blockade will be defined as the time when Modified Bromage scale of 3 is achieved till the time of achievement of Modified Bromage scale of 2.

• HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter every 4 hours till the need for rescue analgesia.

• After the recovery of sensations, pain will be assessed using Visual Analogue Scale (VAS score 0= no pain to 10=worst pain) every hour till the need for rescue analgesia. Rescue analgesia will be administered at a VAS of ≥4.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-09-21
• Study Start: 2021-09-30

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age 18-65 years 2.
• ASA Grade I & II 3.
• Patients scheduled for upper limb orthopedic surgeries.

Exclusion Criteria

• Patients with infection at the site of injection.
• Patients with known history of allergy to any of the study medications .
• Patients with bleeding disorders and those on anti-coagulant therapy.
• Patients with neurological disorders and neuropathy.
• Failure of block (in these patients, general anaesthesia will be supplemented).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries.	Time of giving supraclavicular brachial plexus block is taken as baseline (0 minutes). Patient is monitored every 15 mins in the intraoperative period followed by every 1 hour in the postoperative period upto 24 hours.
To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in	Time of giving supraclavicular brachial plexus block is taken as baseline (0 minutes). Patient is monitored every 15 mins in the intraoperative period followed by every 1 hour in the postoperative period upto 24 hours.

Secondary Outcome Measures

Name	Time	Method
To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups	HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter

Trial Locations

Locations (1)

A.B.V.I.M.S AND DR.RML HOSPITAL; 🇮🇳 Delhi, DELHI, India

A.B.V.I.M.S AND DR.RML HOSPITAL

🇮🇳Delhi, DELHI, India

DR KARTHIGA

Principal investigator

9677556650

karthiga96.mano@gmail.com