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RecruitingNCT07034300Updated Jun 24, 2025

Lidocaine vs. Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA) in Upper Limb Surgery

A Phase 4 interventional study of Lidocaine (drug) and Dexmedetomidine in Post-operative Pain, Upper Limb Surgery and Regional Anesthesia, sponsored by Fatima Memorial Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-24.

Sponsored by Fatima Memorial Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started May 2025; still recruiting 1 year 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post-operative Pain
  • Upper Limb Surgery
  • Regional Anesthesia

Keywords

  • Intravenous Regional Anesthesia
  • Lidocaine
  • Dexmedetomidine
  • Pain
  • Upper Limb Surgery
  • Bier Block
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Fatima Memorial Hospital is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • American Society of Anesthesiology Status I
  • American Society of Anesthesiology Status II
  • Elective surgery
  • Surgery duration \<45 minutes

Exclusion criteria

Exclusion Criteria:

  • Sleep apnea
  • BMI >30
  • Heart block
  • uncontrolled hypertension
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Lidocaine

    Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine

    Drug: Lidocaine (drug)

  • Experimental
    Lidocaine with Dexmedetomidine

    Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg)

    Drug: Lidocaine (drug) · Drug: Dexmedetomidine

Interventions

  • DrugLidocaine (drug)

    40 ml of 0.5% lidocaine

  • DrugDexmedetomidine

    Dexmedetomidine (0.5 μg/kg)

06

What researchers measure

Primary outcomes

  1. Duration of Postoperative Analgesia

    Time from surgery to first request for pain relief

    Time frame: 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

    Time frame: 2 hours post-operation

07

Study locations

1 of 1 sites recruiting
  • Department of Anesthesiology, Fatima Memorial Hospital
    Lahore, Punjab Province 55000, Pakistan
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07034300
Lead sponsor
Fatima Memorial Hospital
Responsible party
Muhammad Mansoor Younas (Principal Investigator, Fatima Memorial Hospital) — Principal investigator
First posted
Jun 24, 2025
Start date
May 21, 2025
Primary completion
Aug 21, 2025 (estimated)
Completion
Aug 31, 2025 (estimated)
Last update
Jun 24, 2025

Study contacts

Muhammad M Younas, MBBS
Contact
mansoor.gujjar344@gmail.com
+923441346810
Muhammad M Younas, MBBS
principal investigator · Fatima Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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