A study to compare analgesic effects of two adjuvants when used with same local anaesthetic in axillary brachial plexus block for forearm and hand surgeries.

A Double Blind Randomized Controlled Trial for analgesic role of Dexmedetomidine vs Dexamethasone as adjuvant in Axillary Brachial plexus block in forearm and hand surgeries. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084011

Enrollment

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S629- Unspecified fracture of wrist andhand Health Condition 2: S529- Unspecified fracture of forearm

Interventions

Intervention1: Axillary Brachial Plexus Block with 0.5% Levobupivacaine and Dexmedetomidine (50 mcg): 30 ml of 0.5% Levobupivacaine (150 mg) and 0.5 ml Dexmedetomidine (50 mcg) with 1.5 ml Distilled W

Dose: Levobupivacaine (2-3mg/kg), Dexmedetomedine (1-1.2mcg/kg)

Frequency: Once

Site: Perineural infiltration of brachial plexus by axillary approach. Duration of procedure: 10 minutes Control Intervention1: Axillary Brachial Plexus Block with 0.5% Levobupivacaine and Dexamethaso

Dose: Levobupivacaine (2-3 mg/kg), Dexamethasone (8 mg)

Site: Perineural infiltration of brachial plexus by axillary approach. Duration of procedure: 10 minutes

Eligibility

Inclusion criteria

Inclusion criteria: 1. ASA Grade I and II. 2. Enrolled for elective forearm and hand surgery under axillary brachial plexus block.

Exclusion criteria

Exclusion criteria: 1. Patient refusal for either the axillary brachial block or participation in the study. 2. Any hypersensitivity or contraindication to study drugs. 3. Pregnant or lactating mothers. 4. Hepatic, renal, or cardiopulmonary abnormality. 5. Chronic alcoholism, uncontrolled hypertension, diabetes, long-term drug therapy. 6. Bleeding diathesis, local skin site infections. 7. History of significant neurological, psychiatric, or neuromuscular disorders (generalized or regional). 8. Patients who have undergone any other clinical trial within the last 3 months.

Design outcomes

Primary

Measure	Time frame
To compare the mean analgesic duration between two groups.Timepoint: 6 hours and 12 hours in post-operative period.	—

Secondary

Measure	Time frame
1. To compare the onset time of sensory & motor block among the two groups. 2. To compare the haemodynamic changes (heart rate & mean blood pressure) among two groups. 3. To compare the total analgesic need among the two groups (over 24 hrs). Timepoint: 1. 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes. 2. 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes in the intra-operative period, 150 minutes, 210 minutes, 270 minutes, 330 minutes, 390 minutes, 450 minutes, 510 minutes, 570 minutes, 630 minutes, 690 minutes, 720 minutes in the post-operative period. 3. Up to 24 hours in the post-operative perod.	—

Measure

Time frame

1. To compare the onset time of sensory & motor block among the two groups. 2. To compare the haemodynamic changes (heart rate & mean blood pressure) among two groups. 3. To compare the total analgesic need among the two groups (over 24 hrs). Timepoint: 1. 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes. 2. 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes in the intra-operative period, 150 minutes, 210 minutes, 270 minutes, 330 minutes, 390 minutes, 450 minutes, 510 minutes, 570 minutes, 630 minutes, 690 minutes, 720 minutes in the post-operative period. 3. Up to 24 hours in the post-operative perod.

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Countries

India

Contacts

Public ContactProf Dr Anjan Das

College of Medicine and Sagore Dutta Hospital

anjan2k8@yahoo.com9874171440

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026