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Supraclavicular Plexus BlockNCT07083934

Ultrasound-Guided Supraclavicular Block With vs Without PNS

A study testing Peripheral nerve stimulator and No peripheral nerve stimulator in people with Supraclavicular Plexus Block and Ultrasound, run by Aga Khan University at 1 site in Pakistan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
What is being tested?
Peripheral nerve stimulator and No peripheral nerve stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
1 Sep 2025to 31 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hafiz Muhammad Motsim Tariq, Mbbs contact

+923072213470

muhammad.motsim@aku.edu

Muhammad Azhar Sharafat, Mbbs FCPS contact

+92 308 2109790

azhar.sharafat@aku.edu

Pakistan1 site
  • Aga Khan University

    Karachi, Sindh, 74800

    Hafiz Muhammad Motsim Tariq, Mbbs, 923072213470, muhammad.motsim@aku.edu

    Muhammad Azhar Sharafat, Mbbs fcps, +92 308 2109790, azhar.sharafat@aku.edu

Other trials in Pakistan

About this study

Official title: Comparison of Ultrasound Guided Supraclavicular Brachial Plexus Block With and Without Peripheral Nerve Stimulation (PNS) Guidance: A Randomized Controlled Tria

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.

Read the detailed description

Peripheral Nerves Blockade (PNB) via local anaesthetics is a method of providing anesthesia and analgesia to the limbs and it was well established in the late 20th century. However, it did not come very well into practice because of unreliability, high rate of complications and failure due to lacking of accurate and reliable techniques of nerve localization at that point in time. It was only when newer nerve localization methods, such as Peripheral Nerve Stimulation (PNS) and Ultrasound (U/S) Imaging started becoming commercially available that the trend of Regional Anaesthesia started getting recognized among the physicians. PNB as a sole anaesthesia technique for limb surgery took further integration in practice and widespread acceptance among anaesthetist in the last decade, once ultrasound technology advanced to newer heights resulting in compact and more mobile units, higher resolution, needle recognition software etc.

When compared to PNS guided regional anaesthesia (PGRA), ultrasound guided regional anaesthesia (UGRA) offers a number of important practical advantages such as direct real-time visualization of the anatomy of interest, needle pathway and its passing through structures and spread of local anaesthetic, and the potential for instantaneous needle re-adjustments as per need. All this allows for safer and more effective distribution of local anaesthetic in the region of desired peripheral nerve. This superiority of Ultrasound Guidance led to fade in the use of PNS guidance in the Regional Anaesthesia practice over the recent years.

Regardless of the previously discussed superiority of U/S Guidance in Regional anaesthesia (RA), it has its own limitations. Such limitations include difficulty in visualization and identifying neural structures when they are lying far away from the skin either due to thick overlying subcutaneous adipose tissue in the obese patients or simply because of the presence of nerve bundle in the deeper tissue planes, and inability to confidently identify and exclude the placement of needle tip within the nerve, where if an injectate is injected will lead to nerve damage.

Such limitations of U/S Guidance in RA can be circumvented by using PNS Guidance in its conjunction. PNS works by delivering a small pulse of electric current through the needle tip which when in close proximity to a neural structure will lead to its stimulation and its respective muscle contraction, thereby helping us in identifying the neural structure of interest. Current density (with pulse duration at 1ms and frequency 2Hz) of around 1 mA for superficial nerves and 1.5-2mA for deeper nerves is enough to elicit a desired motor response. Eliciting a motor response at an even higher current density can be discomforting to the patient as well as misleading to the operator as neural structures can get stimulated through tissues and fascial planes. Similarly, Current density can also be used to predict the intra-fascicular or intraneural needle placement. One study showed that minimum stimulation (Median [interquartile range]) threshold outside was 0.60 mA [0.40-1.0] and inside 0.30 mA [0.20-0.40], where, the difference of 0.30 mA was statistically significant. Therefore, a lower limit for the current density can be used as a safety margin beyond which no muscle activity should be elicited by using PNS.

So, considering the additional benefits of PNS Guidance that it can potentially concur in facilitating UGRA in achieving effective and safer PNB, we propose and design a randomized control trial by comparing the UGRA with and without PNS Guidance in achieving PNB and its outcomes.

Being tested
Peripheral nerve stimulator, No peripheral nerve stimulator

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peripheral nerve stimulatorDevice

    Peripheral nerve stimulator along with ultrasound

  • No peripheral nerve stimulatorDevice

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

Study groups in NCT07083934
Study groupRoleWhat they receive
Ultrasound (US)Active comparatorUse of an ultrasound guidance device without a peripheral nerve stimulator for nerve block placement. Only ultrasound will be used for the procedure.
Receives: Device: No peripheral nerve stimulator
Ultrasound+PNSExperimentalUse of a peripheral nerve stimulator device in combination with ultrasound for nerve block placement.
Receives: Device: Peripheral nerve stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
2 groups assignment 1. Ultrasound and nerve stimulator 2. Only Ultrasound
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083934
Sponsor's protocol ID
2024-9043-30909
Status last verified
Jul 2025
First submitted
13 Jun 2025
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It will be shared among investigatots only

Questions about this trial

What is this clinical trial studying?

A study testing Peripheral nerve stimulator and No peripheral nerve stimulator in people with Supraclavicular Plexus Block and Ultrasound, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hafiz Muhammad Motsim Tariq, Mbbs (+923072213470, muhammad.motsim@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success rate of peripheral nerve block (PNB) with ultrasound-guided regional anesthesia (UGRA) with and without peripheral nerve stimulation (PNS) (time frame: From administration of peripheral nerve block (PNB) until confirmation of successful block onset, assessed up to 60 minutes post-procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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