Comparison of two techniques of upper limb block in upper limb surgeries

Not yet recruiting

• Conditions: Fracture of upper end of radius,

• Registration Number: CTRI/2024/02/062198
• Lead Sponsor: Shree krishna hospital,anand

Brief Summary

After obtaining ethical committee approval and obtaining written and informed consent, patients

of ASA (American society of anaesthesia) I to ASA III physical status who is undergoing elective orthopedic

surgeries the level below the shoulder and distally will be recruited to participate in study. It is a

observational study. Sixty patients will be devided randomly to either ultrasound guided vs peripheral nerve

stimulator guided the supraclavicular block using winpepi software.

Pre anaesthetic check up will be carried out in all patients with detailed clinical history, general

history, as well as general and systemic examination. After checking the overnight fasting of 6-8hours,

arrival to anaesthetic room, an i.v line, a blood pressure cuff and pulse oximetry probe will be attached to

non operated arm. All block will be performed by the 2nd and 3rd year resident with experience of

performing 10-15 blocks using ultrasound under the supervision of an experienced anesthesiologist. A

randomization envelope opened at this stage and the patient will be allocated to either group US or NS. All

block will be performed by the first anesthesiologist who will take no further part in that case management.

Sedation will be administered until the evaluation of the block is completed if required.

· After obtaining written informed consent from all subjects, 60 adult patients, who were American Society

of Anaesthesiology physical status I-III and scheduled for electiveor emergency upper limb surgery will be

studied prospectively.

· The study will be conducted in 2 years from october 2022 to october 2024.

· Total of 60 patients will be enrolled in this observational study and will be randomly divided into two

groups: US (Group US) and NS (Group NS).

All the patients will be fasted adequately. In the operation theatre, patients will be monitored with pulse

oximetry, non invasive blood pressure, and electro cardiogram. After establishing an intravenous access, the

patients received inj. midazolam 1 mg intravenously. No other sedation will be given till evaluation of the

block gets completed.

· The patients will be randomly allotted by closed envelope technique into either of the two groups namely,

US-guided (group US) or NS-guided (group NS). The respective equipment will be kept ready and the drugs

will be loaded maintaining sterility. The drug used will be a 1:1 mixture of 0.5% ropivacaine and 2%

lignocaine with 1:200000 adrenaline. The amount of local anaesthetic injected calculated according to the

body weight and not crossing the toxic dosage (inj. Ropivacaine 4 mg/kg, inj. lignocaine with adrenaline 7

mg/kg). The patients will be positioned supine with the arms by the side and head turned to the opposite side

by 45°. The proposed site of block will be aseptically prepared and draped.

Group US

The probe will be inserted into a sterile plastic sheath so as to maintain sterility. It will be placed in the

coronal oblique plane in the supraclavicular area. The subclavian artery, vein, and the brachial plexus will be

visualized. The brachial plexus and its spatial relationship to the surrounding structures will be scanned. The

plexus will be identified superolateral to the subclavian artery consistently in all the cases. Next, skin will be

anesthetized at the proposed site of entry with 2% lignocaine (2 mL) and a 20 G, 50 mm needle will be

connected to a 50 cm extension line and primed with the drug. It will be inserted from the lateral to medial

direction and the needle movement was observed in real time. Once the needle reached the plexus, after

negative aspiration, drug will be injected and the spread of the drug will

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-01-29
• Study Start: 2024-02-19

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients ASA(american society of anaesthesia) I, II and III physical status 2)Age 18-70yrs of either sex 3)Patients undergoing upper limb surgery.

Exclusion Criteria

1. Patients refusal to regional anaesthesia 2) Skin infection located on or near block injection site 3) Allergy to local anesthetics 4) Presence of bleeding disorder or coagulopathy 5) Patients with preexisting neurological deficit of the same limb 6) Psychiatric disorder 7) Bilateral upper limb surgery 8) Severe chronic obstructive or restrictive lung disease 9) Requirement of conversion to general anaesthesia due to inadequate block.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2)to compare the two techniques of supraclavicular block in terms of Block success rate	10-20mins
3)To compare the hemodynamic parameters: Heart-rate, systolic & diastolic blood pressure, oxygen	10-20mins
saturation & complications like vascular punctures, pneumothorax, nerve palsies, hematoma formation	10-20mins
and infection at injection site.	10-20mins
1)Assess the efficacy & procedure duration in view of onset of sensory blockade in	10-20mins
supraclavicular block ultra sound guided vs peripheral nerve stimulator guided block.	10-20mins
Secondary outcome	10-20mins
1)to compare the two techniques of supraclavicular block in terms of Onset of sensory and	10-20mins
motor block.	10-20mins

Secondary Outcome Measures

Name	Time	Method
1)to compare the two techniques of supraclavicular block in terms of Onset of sensory and	motor block.

Trial Locations

Locations (1)

Shree krishna hospital karamsad; 🇮🇳 Anand, GUJARAT, India

Shree krishna hospital karamsad

🇮🇳Anand, GUJARAT, India

DrVatsal parikh

Principal investigator

8200643179

vatsalparikh.vp@gmail.com