Ultrasound-Guided Mid-Point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block for Pain Management in Patients With Multiple Rib Fractures (A Prospective Randomized Double- Blinded, Non-inferiority Trial )

NCT06981728 | Not Yet Recruiting

• 1 other identifier: fracture ribs
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of our study is to investigate whether the analgesic effect of MTPB is non inferior to that of TPVB in trauma patients with multiple rib fractures.

Conditions

Rib Fractures

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the mean difference in numeric rating pain scores (NRS) between the MTPB and TPVB groups at 24-hour after the block.

  24hour

Secondary Outcomes (8)

• • NRS scores at different times up to 24 hours.

  72hour

• Time for first analgesic request. • Total 24 hours analgesic consumption.

  24hour

• • Total 24 hours analgesic consumption.

  24hour

• • Time for block performance.

  30min

• • Dermatomal block effect.

  24hour

Study Arms (2)

M (MTPB)

ACTIVE COMPARATOR

Mid-point transverse to pleura block

Procedure: Mid point transverse to pleura block

P (TPVB)

SHAM COMPARATOR

Thoracic paravertebral block

Procedure: Mid point transverse to pleura block

Interventions

Mid point transverse to pleura block PROCEDURE

TPVB and MTPB was performed at a spinal level midway between the uppermost and the lowest fractured rib, with the patient in a sitting position, and under complete aseptic conditions, a linear ultrasound probe (GE Healthcare-Logiq F6) will be placed oblique parasagittally 3 cm lateral to spinous process used to identify the transverse process, pleura, superior costotransverse ligament, and the paravertebral space at the target vertebral level. After skin and subcutaneous tissue infiltration with 2-3 mL of 2% lignocaine, an 18-gauge Touhy needle was inserted under ultrasound guidance until the needle tip reaches : * the midpoint between the transverse process and the pleura (group M). * the paravertebral space (group P). A bolus dose (0.3mL/kg) of plain bupivacaine 0.5% plus 8 mg of dexamethasone was injected after negative aspiration to blood and air.

Also known as: Thoracic paravertebral block

M (MTPB); P (TPVB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 70 years, from both genders, who had uni lateral traumatic multiple rib fractures (three or more confirmed by a CT chest scan).

You may not qualify if:

• Significant head injury/unconsciousness (GCS less than 15).
• Patients with Pain score \>6.
• those having significant trauma outside the chest wall, e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries.
• Obese patients with body mass index ≥ 35.
• coagulopathy.
• History of drug allergy to local anesthetics.
• Patient refusal.
• Local infection at the injection site.
• Opioid addiction.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• alaa attia, professor

  alaaguhina@aun.edu.eg

  STUDY DIRECTOR

• Monira Ismail, professor

  Monira.taha77@med.suez.edu.eg

  STUDY DIRECTOR

• muhamed mamdouh, lecturer

  mamdouh372@med.aun.edu.eg

  STUDY DIRECTOR

Central Study Contacts

aya yassien, MD

CONTACT

01096577262; aya.yassien1994@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: According to computer-generated software randomization (www.randomization.com) table into two groups of 35 each, patients randomly were allocated to Group M or Group P at a ratio of 1:1. * Group M: mid-point transverse to pleura block. * Group P: thoracic paravertebral block. The grouping sequence was put into a sealed opaque envelope, the operator opened the envelope to identify the type of block. Patients were blinded to the grouping assignments. After trial completion, all participants remained unaware of the grouping assignments until un blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD doctor

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 21, 2025

Record last verified: 2025-05