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

NCT ID: NCT07034300

Last Updated: 2025-06-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-21
• Study Completion Date: 2025-08-31

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lidocaine

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine

Group Type: ACTIVE_COMPARATOR

Lidocaine (drug)

Intervention Type: DRUG

40 ml of 0.5% lidocaine

Lidocaine with Dexmedetomidine

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

Group Type: EXPERIMENTAL

Lidocaine (drug)

Intervention Type: DRUG

40 ml of 0.5% lidocaine

Dexmedetomidine

Intervention Type: DRUG

Dexmedetomidine (0.5 μg/kg)

Interventions

Lidocaine (drug)

40 ml of 0.5% lidocaine

Intervention Type: DRUG

Dexmedetomidine

Dexmedetomidine (0.5 μg/kg)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatima Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Mansoor Younas

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muhammad M Younas, MBBS

Role: PRINCIPAL_INVESTIGATOR

Fatima Memorial Hospital

Locations

Department of Anesthesiology, Fatima Memorial Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad M Younas, MBBS

Role: CONTACT

mansoor.gujjar344@gmail.com

+923441346810

Facility Contacts

Mansoor M Younas, MBBS

Role: primary

mansoor.gujjar344@gmail.com

+923441346810

Other Identifiers

MMY-LidoDex-IVRA-2025

Identifier Type: -

Identifier Source: org_study_id