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Pain reduction with hematoma block in patients with clavicle fracture

Effect of Ultrasound-Guided Hematoma Block Versus Intravenous Opioids on Pain Reduction in Patients with Clavicle Fracture: A Prospective Parallel-Group Open-label Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094089
Enrollment
56
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ultrasound Guided Hematoma Block (UGHB): High frequency linear probe will be used to inject 5 ml of 1 percent Lidocaine and 5 ml of 0.25 percent Ropivacaine into fracture hematoma. 21 o

Sponsors

Sanjeev Kumar Bhoi
Lead Sponsor
Abhiraj R
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients presenting with acute clavicle fracture (within 24 hours of injury). Radiologically confirmed clavicle fracture. Defence and Veterans Pain Rating Scale (DVPRS) pain score of 7 or more on arrival. Ability to provide informed written consent.

Exclusion criteria

Exclusion criteria: Known allergy to local anesthetics or opioids. Hemodynamic instability (SBP less than 90 mmHg or HR more than 130 bpm). Polytrauma requiring immediate surgical interventions. Fractures with neurovascular compromise. Open clavicle fractures. History of substance abuse or chronic opioid use. Cognitive impairment or psychiatric illness. interfering with consent or communication Local infection or overlying skin lesions at the proposed injection site. Pregnancy or breastfeeding. Those who do not give consent.

Design outcomes

Primary

MeasureTime frame
50 percent reduction in pain score (DVPRS 0?10) at 30 minutes post-interventionTimepoint: 30 minutes—

Secondary

MeasureTime frame
DVPRS scores at 15, 30, 60, and 120 minutes post-interventionTimepoint: 15, 30, 60, and 120 minutes;Requirement for rescue analgesia (defined as DVPRS score of 7 or more at 30 min)Timepoint: 30 minutes;Incidence of side effects: nausea, vomiting, sedation, respiratory depression, allergic reactions, local anaesthetic systemic toxicity or any other.Timepoint: 120 minutes;Time taken to perform Hematoma block (excluding scanning and preparation time)Timepoint: ;Patient satisfaction score at 2 hours (Likert scale 1?5)Timepoint: 120 minutes—

Countries

India

Contacts

Public ContactSanjeev Kumar Bhoi

All India Institute of Medical Sciences, New Delhi

sanjeevbhoi@gmail.com8527050391

Outcome results

None listed

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