Mid-point to Pleura Transverse Process Block Versus Thoracic Intervertebral Foramen Block

NCT05348330 | Completed DMC

• 1 other identifier: 10814/21
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The analgesic effect of continuous mid-point to pleura transverse process block compared to the analgesic effect of continuous thoracic intervertebral foramen block, in patients with multiple rib fractures.

Conditions

Pain, Acute; Rib Fractures; Polytrauma

Keywords

Analgesia; Local anesthetics; Myofascial block; Ultrasound guidance

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"

  First 72 hours from the block

Secondary Outcomes (8)

• Diaphragmatic motion

  First 72 hours from the block

• Arterial blood gas analysis

  First 72 hours from the block

• Airflow rate

  First 72 hours from the block

• Blood pressure

  First 72 hours from the block

• Sensory block

  First 72 hours from the block

Study Arms (2)

Thoracic intervertebral foramen block

EXPERIMENTAL

Under ultrasound guidance the continuous thoracic intervertebral foramen block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.

Procedure: Thoracic intervertebral foramen block

Mid-point to pleura transverse process block

ACTIVE COMPARATOR

Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain.

Procedure: Mid-point to pleura transverse process block

Interventions

Thoracic intervertebral foramen block PROCEDURE

Under ultrasound guidance the continuous thoracic intervertebral foramen block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.

Thoracic intervertebral foramen block

Mid-point to pleura transverse process block PROCEDURE

Under ultrasound guidance the continuous mid-point to pleura transverse process block, will be provided to achieve analgesia in polytraumatic patients with rib fractures. A set for continuous peripheral nerve block will be used. The infusion rate of analgesic solution (levobupivacaine 0.25% combined with dexamethasone 16 mg) will be titrated to patient perceived pain. The block will be performed close, by considering the level of rib fractures.

Mid-point to pleura transverse process block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ribs fracture after polytrauma

You may not qualify if:

• pregnancy
• allergy to anesthetics
• head trauma
• history of neurological impairment (primary or secondary)
• history of cancer
• history of chronic obstructive pulmonary disease
• infections of skin close to the block site
• systemic infections

Sponsors & Collaborators

• San Salvatore Hospital of L'Aquila: lead

Study Sites (1)

Emiliano

L’Aquila, L'Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Acute Pain; Rib Fractures; Multiple Trauma; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Emiliano Petrucci, MD

  San Salvatore Acadec Hospital of L'Aquila (Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 27, 2022
• Study Start: December 4, 2022
• Primary Completion: October 31, 2024
• Study Completion: November 28, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)