Ultrasound-Guided Supraclavicular Block With vs Without PNS

NCT07083934 | Not Yet Recruiting

• 1 other identifier: 2024-9043-30909
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral Nerve Blockade (PNB) became reliable with the advent of Ultrasound (US) and Peripheral Nerve Stimulation (PNS). US offers real-time visualization but has limitations, especially with deep or obscured nerves. PNS complements US by confirming nerve proximity through motor responses. Combining both may enhance safety and success of nerve blocks. This study compares US-guided blocks with and without PNS in a randomized trial.

Conditions

Supraclavicular Plexus Block; Ultrasound; Anaesthesia

Outcome Measures

Primary Outcomes (1)

• Success rate of peripheral nerve block (PNB) with ultrasound-guided regional anesthesia (UGRA) with and without peripheral nerve stimulation (PNS)

  Comparison of PNB success rate between UGRA alone and UGRA combined with PNS guidance.

  From administration of peripheral nerve block (PNB) until confirmation of successful block onset, assessed up to 60 minutes post-procedure

Study Arms (2)

Ultrasound (US)

ACTIVE COMPARATOR

Use of an ultrasound guidance device without a peripheral nerve stimulator for nerve block placement. Only ultrasound will be used for the procedure.

Device: No peripheral nerve stimulator

Ultrasound+PNS

EXPERIMENTAL

Use of a peripheral nerve stimulator device in combination with ultrasound for nerve block placement.

Device: Peripheral nerve stimulator

Interventions

Peripheral nerve stimulator DEVICE

Peripheral nerve stimulator along with ultrasound

Ultrasound+PNS

No peripheral nerve stimulator DEVICE

No peripheral nerve stimulator with ultrasound. Only ultrasound will be used

Ultrasound (US)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 years and older
• ASA physical status I to IV
• No contraindications to regional anaesthesia
• Operative site located at the mid to lower arm, including the elbow, forearm, wrist, or hand
• Ability to provide informed consent
• Ability to reliably report symptoms to the research team related to regional anaesthesia

You may not qualify if:

• Patient's refusal to participate.
• Inability to provide first-party consent due to cognitive impairment.
• Cognitive dysfunction which can lead to difficulties in communication and cooperation of patient.
• Preexisting neuropathy.
• Preexisting coagulopathy.
• Patients who will be shifted to ICU due to post - operative ventilatory support.

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Study Officials

• Azhar Rehman, Mbbs Fcps

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafiz Muhammad Motsim Tariq, Mbbs

CONTACT

+923072213470; muhammad.motsim@aku.edu

Muhammad Azhar Sharafat, Mbbs FCPS

CONTACT

+92 308 2109790; azhar.sharafat@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 groups assignment 1. Ultrasound and nerve stimulator 2. Only Ultrasound

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 31, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)