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.
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
- Conditions the study is for
- Supraclavicular Plexus Block, Ultrasound, Anaesthesia
- 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.
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
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.
- Conditions
- Supraclavicular Plexus Block, Ultrasound, Anaesthesia
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: No peripheral nerve stimulator |
| Ultrasound+PNS | Experimental | Use 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.
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.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supraclavicular Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Azhar Rehman, Mbbs Fcps, Principal investigator, Aga Khan University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Supraclavicular Brachial Plexus Block With and Without Peripheral Nerve Stimulation (PNS) Guidance: A Randomized Controlled Tria
- ClinicalTrials.gov ID
- NCT07083934
- Acronym / sponsor ID
- 2024-9043-30909
- Conditions
- Supraclavicular Plexus Block, Ultrasound, Anaesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups assignment 1. Ultrasound and nerve stimulator 2. Only Ultrasound
| Arm | Type | Receives |
|---|---|---|
| Ultrasound (US) | Active comparator | Device: No peripheral nerve stimulatorUse of an ultrasound guidance device without a peripheral nerve stimulator for nerve block placement. Only ultrasound will be used for the procedure. |
| Ultrasound+PNS | Experimental | Device: Peripheral nerve stimulatorUse of a peripheral nerve stimulator device in combination with ultrasound for nerve block placement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral nerve stimulatorPeripheral nerve stimulator along with ultrasound | Device | Ultrasound+PNS |
| No peripheral nerve stimulatorNo peripheral nerve stimulator with ultrasound. Only ultrasound will be used | Device | Ultrasound (US) |
Primary outcome
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
Comparison of PNB success rate between UGRA alone and UGRA combined with PNS guidance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No. It will be shared among investigatots only
Related trials for Supraclavicular Plexus Block
Recruiting
Sensorimotor Block Dynamics and Hemidiaphragmatic Palsy: Selective Trunk Block vs Supraclavicular Brachial Plexus Block
Musculoskeletal Diseases or Conditions
Not yet recruiting
Ultrasound Guidance Intercostobrachial Nerve Block in AVF Superficialization
Supraclavicular Plexus Block Procedure (SCPB), ESRD
RecruitingPhase 3
Liposomal Bupivacaine Plus Plain Bupivacaine Versus Dexamethasone Plus Plain Bupivacaine in the Supraclavicular Brachial Plexus Block in Patients With Risk Factors for Severe Acute Postoperative Pain
Pain, Postoperative, Liposomal Bupivacaine
Not yet recruitingObservational study
Early Detection of Ulnar Sparing After Supraclavicular Block Using Infrared Thermography and Perfusion Index
Elective Upper Limb Surgery Distal to the Elbow
Not yet recruitingPhase 4
Perineural Dexamethasone, Dexmedetomidine, or Their Combination to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block
Brachial Plexus Blocks
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azhar Rehman, Mbbs Fcps principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
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.