Post-operative PainPhase 4NCT07034300
Lidocaine vs. Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA) in Upper Limb Surgery
A Phase 4 study testing Lidocaine (drug) and Dexmedetomidine in people with Post-operative Pain and Upper Limb Surgery, run by Fatima Memorial Hospital at 1 site in Pakistan.
Trial summary
This study compares lidocaine alone vs. lidocaine with dexmedetomidine in Intravenous regional anesthesia (IVRA) for upper limb surgery in terms of pain scores and duration of analgesia Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-operative Pain, Upper Limb Surgery, Regional Anesthesia
- What is being tested?
- Lidocaine (drug) and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 21 May 2025to 31 Aug 2025
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology Status I
- American Society of Anesthesiology Status II
- Elective surgery
- Surgery duration <45 minutes
Who cannot join
- Sleep apnea
- BMI >30
- Heart block
- uncontrolled hypertension
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
Department of Anesthesiology, Fatima Memorial Hospital
Lahore, Punjab Province, 55000
Mansoor M Younas, MBBS, +923441346810, mansoor.gujjar344@gmail.com
Muhammad M Younas, MBBS
About this study
Official title: Comparison of Lidocaine Alone Versus Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA)
This study compares lidocaine alone vs. lidocaine with dexmedetomidine in Intravenous regional anesthesia (IVRA) for upper limb surgery in terms of pain scores and duration of analgesia
Read the detailed description
Intravenous regional anesthesia effectively anesthetizes limbs for surgeries lasting under one hour. This method involves applying a pneumatic tourniquet and injecting a local anesthetic below the tourniquet to directly target major nerves. Intravenous regional anesthesia has certain limitations, including tourniquet-related pain, risk of local anesthetic systemic toxicity, limited postoperative pain relief, and the potential risk of compartment syndrome. Despite these concerns, it remains a reliable technique with reported success rates between ninety-four percent and ninety-eight percent.
This technique, originally introduced by August Bier, isolates the limb using pressure and a pneumatic tourniquet to retain the anesthetic effect in the target area. Lidocaine, a commonly used amide-type local anesthetic, was popularized for this method after successful use in 1963. However, lidocaine alone has limitations, such as incomplete sensory nerve block, discomfort from the tourniquet, and minimal pain control after the tourniquet is released. To improve these outcomes, additives have been combined with local anesthetics to enhance pain relief after the procedure and reduce intraoperative discomfort. However, the use of such additives has been limited due to concerns about side effects or uncertain effectiveness.
Alpha-2 adrenergic receptor agonists have recently gained attention for their sedative, pain-relieving, and cardiovascular-stabilizing effects in the perioperative setting. These agents can reduce the need for general anesthesia and prolong the effects of local anesthetics in regional anesthesia techniques. Clonidine, one such medication, when added to local anesthetics, has been associated with improved pain control in spinal, epidural, and peripheral nerve blocks compared to the use of local anesthetics alone. Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, offers a rapid onset of action and is recognized for its beneficial sedative and pain-relieving properties.
Dexmedetomidine has additional pharmacological effects, including lowering blood pressure, reducing anxiety, and providing sedation. These properties make it useful in clinical practice, especially in the management of surgical pain and in maintaining comfort for patients in critical care settings. It is often used both during surgical procedures and for sedation in intensive care units.
Studies comparing the use of lidocaine alone versus lidocaine combined with dexmedetomidine have shown that the combination significantly improves the duration of postoperative pain relief and reduces patient-reported pain levels. One study reported a longer duration of pain relief and lower pain scores in patients who received dexmedetomidine along with lidocaine. Another study found similar improvements in both the length of pain relief and pain intensity scores when the combination was used. Despite these promising results, there is a noticeable lack of research on this topic within Pakistan, largely due to the previous unavailability of dexmedetomidine in the local market. Therefore, this study was designed to compare the effectiveness of lidocaine alone versus lidocaine combined with dexmedetomidine in the setting of intravenous regional anesthesia.
- Conditions
- Post-operative Pain, Upper Limb Surgery, Regional Anesthesia
- Being tested
- Lidocaine (drug), Dexmedetomidine
- Keywords
- Intravenous Regional Anesthesia, Lidocaine, Dexmedetomidine, Pain, Upper Limb Surgery, Bier Block
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
40 ml of 0.5% lidocaine
DexmedetomidineDrug
Dexmedetomidine (0.5 μg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine Receives: Drug: Lidocaine (drug) |
| Lidocaine with Dexmedetomidine | Experimental | Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg) Receives: Drug: Lidocaine (drug); Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Postoperative Analgesia
Time from surgery to first request for pain relief
Measured: Up to 24 hours post surgery
Secondary outcomes (1)
Pain Score according to Visual Analogue Scale (VAS)
Mean Pain Score according to Visual Analogue Scale (VAS) measured on a 0-10 scale, 0 being no pain at all and 10 meaning worst pain imaginable
Measured: 2 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start21 May 2025
- Primary completion21 Aug 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fatima Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Mansoor Younas, Fatima Memorial Hospital
- Investigators
- Muhammad M Younas, MBBS, Principal investigator, Fatima Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034300
- Sponsor's protocol ID
- MMY-LidoDex-IVRA-2025
- Status last verified
- Jun 2025
- First submitted
- 15 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to institutional policy and data privacy considerations. The data are not intended for secondary use beyond the scope of this study.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lidocaine Alone Versus Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA)
- ClinicalTrials.gov ID
- NCT07034300
- Acronym / sponsor ID
- MMY-LidoDex-IVRA-2025
- Conditions
- Post-operative Pain, Upper Limb Surgery, Regional Anesthesia
- Keywords
- Intravenous Regional Anesthesia, Lidocaine, Dexmedetomidine, Pain, Upper Limb Surgery, Bier Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Fatima Memorial HospitalUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 21 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 24 Jun 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.
This study compares lidocaine alone vs. lidocaine with dexmedetomidine in Intravenous regional anesthesia (IVRA) for upper limb surgery in terms of pain scores and duration of analgesia
Detailed description
Intravenous regional anesthesia effectively anesthetizes limbs for surgeries lasting under one hour. This method involves applying a pneumatic tourniquet and injecting a local anesthetic below the tourniquet to directly target major nerves. Intravenous regional anesthesia has certain limitations, including tourniquet-related pain, risk of local anesthetic systemic toxicity, limited postoperative pain relief, and the potential risk of compartment syndrome. Despite these concerns, it remains a reliable technique with reported success rates between ninety-four percent and ninety-eight percent.
This technique, originally introduced by August Bier, isolates the limb using pressure and a pneumatic tourniquet to retain the anesthetic effect in the target area. Lidocaine, a commonly used amide-type local anesthetic, was popularized for this method after successful use in 1963. However, lidocaine alone has limitations, such as incomplete sensory nerve block, discomfort from the tourniquet, and minimal pain control after the tourniquet is released. To improve these outcomes, additives have been combined with local anesthetics to enhance pain relief after the procedure and reduce intraoperative discomfort. However, the use of such additives has been limited due to concerns about side effects or uncertain effectiveness.
Alpha-2 adrenergic receptor agonists have recently gained attention for their sedative, pain-relieving, and cardiovascular-stabilizing effects in the perioperative setting. These agents can reduce the need for general anesthesia and prolong the effects of local anesthetics in regional anesthesia techniques. Clonidine, one such medication, when added to local anesthetics, has been associated with improved pain control in spinal, epidural, and peripheral nerve blocks compared to the use of local anesthetics alone. Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, offers a rapid onset of action and is recognized for its beneficial sedative and pain-relieving properties.
Dexmedetomidine has additional pharmacological effects, including lowering blood pressure, reducing anxiety, and providing sedation. These properties make it useful in clinical practice, especially in the management of surgical pain and in maintaining comfort for patients in critical care settings. It is often used both during surgical procedures and for sedation in intensive care units.
Studies comparing the use of lidocaine alone versus lidocaine combined with dexmedetomidine have shown that the combination significantly improves the duration of postoperative pain relief and reduces patient-reported pain levels. One study reported a longer duration of pain relief and lower pain scores in patients who received dexmedetomidine along with lidocaine. Another study found similar improvements in both the length of pain relief and pain intensity scores when the combination was used. Despite these promising results, there is a noticeable lack of research on this topic within Pakistan, largely due to the previous unavailability of dexmedetomidine in the local market. Therefore, this study was designed to compare the effectiveness of lidocaine alone versus lidocaine combined with dexmedetomidine in the setting of intravenous regional anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine (drug)Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine |
| Lidocaine with Dexmedetomidine | Experimental | Drug: Lidocaine (drug), Drug: DexmedetomidineIntravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiology Status I
- American Society of Anesthesiology Status II
- Elective surgery
- Surgery duration <45 minutes
Key exclusion criteria (4 listed)
- Sleep apnea
- BMI >30
- Heart block
- uncontrolled hypertension
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 |
|---|---|---|
| Lidocaine (drug)40 ml of 0.5% lidocaine | Drug | Lidocaine, Lidocaine with Dexmedetomidine |
| DexmedetomidineDexmedetomidine (0.5 μg/kg) | Drug | Lidocaine with Dexmedetomidine |
Primary outcome
Duration of Postoperative Analgesia
Time frame: Up to 24 hours post surgery
Time from surgery to first request for pain relief
1 secondary outcome
Pain Score according to Visual Analogue Scale (VAS)
Time frame: 2 hours post-operation
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 Jun 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to institutional policy and data privacy considerations. The data are not intended for secondary use beyond the scope of this study.
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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.
Muhammad M Younas, MBBS principal investigator
Fatima Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine (drug) and Dexmedetomidine in people with Post-operative Pain and Upper Limb Surgery, run by Fatima Memorial Hospital 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 4 inclusion and 4 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 24 Jun 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Muhammad M Younas, MBBS (+923441346810, mansoor.gujjar344@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Postoperative Analgesia (time frame: Up to 24 hours post surgery). 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 Jun 2025.