Post Operative AnalgesiaPhase 2/3NCT07290595
Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries
A Phase 2/3 study testing Ropivacaine + Dexmedetomidine and Ropivacaine + dexamethasone in people with Post Operative Analgesia and Bradycardia, run by Sahiwal medical college sahiwal at 1 site in Pakistan.
Trial summary
To compare the efficacy of dexmedetomidine and dexamethasone as an adjuvant to 0.5%ropivacaine on onset of ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia, Bradycardia, Hypotension
- What is being tested?
- Ropivacaine + Dexmedetomidine and Ropivacaine + dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jan 2025to 12 Mar 2026
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients scheduled for upper limb surgery below mid-humerus level
- Patients aged 18 to 70 years
- Patients with ASA class I, II and III
- Male and non-pregnant females Exclusion Criteria
- Patients refusal
- Patients with pre-existing peripheral neuropathy of the upper limb
Show all 10Show fewer
- Patients with the Infection at block site
- Patients with history of ischemic heart disease
- Patients with bleeding disorder or deranged coagulation profile
- Patients with known history of allergy to local anaesthetic or any other drugs used
Who cannot join
None listed.
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, 1 recruiting
- Recruiting
Sahiwal Medical College, Sahiwal
Sāhīwāl, Punjab Province, 57000
Dr Rao Riaz ul Haq, FCPS, 0092404502470, slmcswl@gmail.com
Dr Maryam Maqsood, MBBS
About this study
To compare the efficacy of dexmedetomidine and dexamethasone as an adjuvant to 0.5%ropivacaine on onset of ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries.
Ropivacaine hydrochloride, a long acting local anesthetic, is commonly used for supraclavicular block owing to its favorable safety profile especially in terms of minimal cardiotoxicity and less motor block. Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, enhances the quality of supraclavicular block by providing sedation and analgesia while potentially prolonging the duration of block through hyperpolarization of nerve fibers. While, Dexamethasone, a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties, prolongs duration of analgesia by reducing perineural inflammation and inhibiting nociceptive signal transmission. Supraclavicular brachial plexus block offers dense anesthesia for surgical procedures at or distal to the elbow with relatively high success rate, once described as "spinal of the arm". Moreover, supraclavicular brachial plexus block is an excellent alternative to general anesthesia in upper limb surgeries.
Read the detailed description
After preparation, patients will be randomized into two groups of 33 each, where group A will receive 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) and group B will receive 28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml). Anesthetist involved in drug administration and observation will be blinded to coded drugs prepared by another anesthetist who will not be involved further in the study. A detailed history will be taken regarding mode of injury, any pre-existing disease and previous surgery followed by local examination of patient will be done to rule out any systemic disease. On shifting to the operation theatre, standard monitoring like pulse-oximeter, electrocardiogram and non-invasive blood pressure measurement will be started. Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30o toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood, study drugs will be injected in 5ml increments to obtain uniform spread around brachial plexus. Patient will be assessed every 5 minutes till complete sensory and motor block or for 30 minutes, whichever is earlier, using three point scale with pin prick technique for sensory block and modified bromage scale for motor block. Side effects and complications of the technique and drugs will be monitored and appropriately treated. Outcome of study will be to compare the time of onset of sensory and motor block between 2 groups.
- Being tested
- Ropivacaine + Dexmedetomidine, Ropivacaine + dexamethasone
- Medical subject headings
- Bradycardia, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine + DexmedetomidineDrug
Also called Supravlavicular Brachial Plexus Block with Ropivacaine and Dexmedetomidine
Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood, 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) will be injected in 5ml increments to obtain uniform spread around brachial plexus
Ropivacaine + dexamethasoneDrug
Also called Supraclavicular Brachial Plexus Block with Ropivacaine and Dexamethasone
Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood,28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml)will be injected in 5ml increments to obtain uniform spread around brachial plexus
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine Receives: Drug: Ropivacaine + Dexmedetomidine |
| Group B | Other | 0.5%Ropivacaine + 8mg Dexamethasone Receives: Drug: Ropivacaine + dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Analgesia
Onset of Sensory Block
Measured: from performance of Block upto 5 minutes
Post Operative Analgesia
Onset of Motor Block
Measured: from performance of block upto 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start13 Jan 2025
- Primary completion12 Feb 2026 (estimated)
- Study completion12 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative AnalgesiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A will receive 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) and Group B will receive 28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahiwal medical college sahiwal
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Maryam Maqsood, Sahiwal medical college sahiwal
- Investigators
- Adeel Riaz, MD, Study director, Sahiwal medical college sahiwal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290595
- Sponsor's protocol ID
- 173-IRB/SLMC/SWL
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on request after completion of study i.e. March 2026
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries
- ClinicalTrials.gov ID
- NCT07290595
- Acronym / sponsor ID
- 173-IRB/SLMC/SWL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sahiwal medical college sahiwalOther government
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 12 Feb 2026 (estimated)
- Study completion
- 12 Mar 2026 (estimated)
- First posted
- 18 Dec 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.
To compare the efficacy of dexmedetomidine and dexamethasone as an adjuvant to 0.5%ropivacaine on onset of ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries.
Ropivacaine hydrochloride, a long acting local anesthetic, is commonly used for supraclavicular block owing to its favorable safety profile especially in terms of minimal cardiotoxicity and less motor block. Dexmedetomidine, a highly selective alpha-2 adrenergic agonist, enhances the quality of supraclavicular block by providing sedation and analgesia while potentially prolonging the duration of block through hyperpolarization of nerve fibers. While, Dexamethasone, a synthetic corticosteroid with potent anti-inflammatory and immunosuppressive properties, prolongs duration of analgesia by reducing perineural inflammation and inhibiting nociceptive signal transmission. Supraclavicular brachial plexus block offers dense anesthesia for surgical procedures at or distal to the elbow with relatively high success rate, once described as "spinal of the arm". Moreover, supraclavicular brachial plexus block is an excellent alternative to general anesthesia in upper limb surgeries.
Detailed description
After preparation, patients will be randomized into two groups of 33 each, where group A will receive 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) and group B will receive 28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml). Anesthetist involved in drug administration and observation will be blinded to coded drugs prepared by another anesthetist who will not be involved further in the study. A detailed history will be taken regarding mode of injury, any pre-existing disease and previous surgery followed by local examination of patient will be done to rule out any systemic disease. On shifting to the operation theatre, standard monitoring like pulse-oximeter, electrocardiogram and non-invasive blood pressure measurement will be started. Supraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30o toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood, study drugs will be injected in 5ml increments to obtain uniform spread around brachial plexus. Patient will be assessed every 5 minutes till complete sensory and motor block or for 30 minutes, whichever is earlier, using three point scale with pin prick technique for sensory block and modified bromage scale for motor block. Side effects and complications of the technique and drugs will be monitored and appropriately treated. Outcome of study will be to compare the time of onset of sensory and motor block between 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group A will receive 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) and Group B will receive 28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml).
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Drug: Ropivacaine + Dexmedetomidine0.5%Ropivacaine + 1mcg/kg Dexmedetomidine |
| Group B | Other | Drug: Ropivacaine + dexamethasone0.5%Ropivacaine + 8mg Dexamethasone |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients scheduled for upper limb surgery below mid-humerus level
- Patients aged 18 to 70 years
- Patients with ASA class I, II and III
- Male and non-pregnant females Exclusion Criteria
- Patients refusal
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ropivacaine + DexmedetomidineAlso: Supravlavicular Brachial Plexus Block with Ropivacaine and DexmedetomidineSupraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood, 28ml of 0.5%Ropivacaine + 1mcg/kg Dexmedetomidine (diluted in 2ml normal saline) will be injected in 5ml increments to obtain uniform spread around brachial plexus | Drug | Group A |
| Ropivacaine + dexamethasoneAlso: Supraclavicular Brachial Plexus Block with Ropivacaine and DexamethasoneSupraclavicular brachial plexus block will be performed under aseptic measures with the patient lying supine with head turned 30 degrees toward the contralateral side. A linear 7-13 MHz ultrasonography probe (ACUSON P500, digital color doppler ultrasound Siemens Germany) will be placed in supraclavicular fossa and slightly angled towards the thorax. The brachial plexus appears as multiple hypoechoic disks just superficial and lateral to the subclavian artery. After identification of brachial plexus, the proposed puncture site will be infiltrated with 1ml of 2% lignocaine. Then, 25-gauge spinal needle will be inserted using in plane technique, from lateral to medial direction until the tip is visualized near the brachial plexus. After careful aspiration for blood,28ml of 0.5%Ropivacaine + 8mg Dexamethasone (2ml)will be injected in 5ml increments to obtain uniform spread around brachial plexus | Drug | Group B |
Primary outcome
Post Operative Analgesia
Time frame: from performance of Block upto 5 minutes
Onset of Sensory Block
Post Operative Analgesia
Time frame: from performance of block upto 5 minutes
Onset of Motor Block
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 23 Dec 2025.
- Individual participant dataSharing planned: Yes. Data will be available on request after completion of study i.e. March 2026
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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.
Adeel Riaz, MD study director
Sahiwal medical college sahiwal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine + Dexmedetomidine and Ropivacaine + dexamethasone in people with Post Operative Analgesia and Bradycardia, run by Sahiwal medical college sahiwal 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 10 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 23 Dec 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Dr Maryam Maqsood, MBBS (00923347036271, maryammaqsood448@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Analgesia (time frame: from performance of Block upto 5 minutes). The study lists 2 primary outcomes in all. 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 23 Dec 2025.