Ultrasound-Guided Continuous Serratus Anterior Plane Block vs Dexmedetomidine Infusion in Patients With Rib Fractures.

NCT05965895 | Unknown Phase 4

• 1 other identifier: FMBSUREC/09072023/Fakhry
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work is to compare analgesic efficacy in patients with multiple rib fractures who will be managed with Ultrasound-guided continuous serratus anterior plane block versus patients who will be managed with dexmedetomidine infusion.

Conditions

Pain

Keywords

Serratus anterior; Dexmedetomidine; Rib; Fractures

Outcome Measures

Primary Outcomes (1)

• Quality of analgesia measured by visual analogue scale

  rate pain severity scored from 0 to 10; while 0 stands for no pain at all and 10 is the worst intolerable pain.

  The first 48 hours.

Secondary Outcomes (2)

• parameters of adequate ventilation and oxygenation

  at 1, 2, 3, 4, 8, 16, 24, 36, 48 hours.

• Sedation score

  Every 8 hours for 48 hours

Study Arms (2)

US-guided SAP block group

ACTIVE COMPARATOR

Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.

Procedure: Ultrasound-guided continuous serratus anterior plane block

Dexmedetomidine group

ACTIVE COMPARATOR

Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.

Drug: intravenous dexmedetomidine infusion

Interventions

Ultrasound-guided continuous serratus anterior plane block PROCEDURE

Patients will receive US-guided SAP block with a bolus of 2 mg/kg levobupivacaine made up to a volume of 40 ml followed by an infusion of 0.125% levobupivacaine will be commenced at rate of 8 ml/hr for 48 hr.

Also known as: Group S

US-guided SAP block group

intravenous dexmedetomidine infusion DRUG

Patients will receive initial loading dose of dexmedetomidine of 1 µg/kg over 30 min followed by a continuous infusion at a rate of 0.5 µg/kg/hr for 48 hr.

Also known as: Group D

Dexmedetomidine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Rib fracture score of more than 7
• Patient with isolated multiple rib fractures, ●American Society of Anesthesiologists classification of physical status \< IV
• Body mass index (BMI) ≤ 35.

You may not qualify if:

• Refusal of the patient
• Trauma survey include multiple injuries including head injuries, visceral and long bone fractures
• Intubated patients
• Known hypersensitivity to any study medication, ●Chronic opioid use or chronic pain patient, ●Hemodynamic instability
• Haemothorax or pneumothorax.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, 62814, Egypt

RECRUITING

MeSH Terms

Conditions

Pain; Fractures, Bone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Dina M Fakhry, MD

  Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dina M Fakhry, MD

CONTACT

+201289998680; dina_fakhry_91@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

EG (1)