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NCT Number: NCT07034300

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Anesthesiology, Fatima Memorial Hospital

Lahore, Punjab Province, 55000, Pakistan

Location status: Recruiting

Location contact

Mansoor M Younas, MBBS

CONTACT

[email protected]

+923441346810

Muhammad M Younas, MBBS

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Lidocaine (drug)

Drug

40 ml of 0.5% lidocaine

Dexmedetomidine

Drug

Dexmedetomidine (0.5 μg/kg)

Primary outcomes

  1. Duration of Postoperative Analgesia

    Time frame: Up to 24 hours post surgery

    Time from surgery to first request for pain relief

Secondary outcomes

  1. Pain Score according to Visual Analogue Scale (VAS)

    Time frame: 2 hours post-operation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Muhammad M Younas, MBBS

CONTACT

[email protected]

+923441346810

Sponsors and collaborators

Lead sponsor

Fatima Memorial Hospital

Other

Registry information

Official study title

Comparison of Lidocaine Alone Versus Lidocaine With Dexmedetomidine for Intravenous Regional Anesthesia (IVRA)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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