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NCT Number: NCT06981728

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 )

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Trauma is a major global health problem. In Egypt, trauma-related death accounted for 8% of total fatalities and was the eighth leading cause of death in 2010. However.[1]Rib fractures have an incidence around 10% of all trauma patients and over 30% of chest trauma patients.[2] Multiple fractured ribs are associated with extreme pain, to avoid intensifying discomfort, patients' breathing becomes shallower and they repress coughing, leading to respiratory insufficiency. Which may result in numerous complications, as sputum retention, atelectasis, infection, and respiratory insufficiency. This is associated with increase in intensive care admissions and mortality (25%).[3] Hence, pain control is the cornerstone of rib fracture management. Modalities for pain relief ranges from oral administration of analgesic drugs to regional nerve blocks including [intrapleural, intercostal ,thoracic paravertebral nerve blockade (TPVB)]. Despite the low rate of technical failure in TPVB execution (6.1%), pulmonary complications, such as inadvertent pleural puncture (0.8%) and pneumothorax (0.5%), are still a recognized risk.[4] Bedside ED-performed ultrasound-guided anesthesia is gaining in popularity, and early and adequate pain control has shown improved patient outcomes with rare complications.

One of the most recently described technique is mid-point transverse process to pleura (MTP) block.[2] In MTP block, the local anesthetic drug is deposited at the mid-point between the transverse process and pleura and it reaches the paravertebral space by diffusion. With this technique, even if superior costotransverse ligament (SCTL) is not visible, effective block can be achieved. In addition, needle is placed far away from pleura minimizing the rate of pneumothorax.[5]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Thoracic paravertebral block

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.

    Time frame: 24hour

Secondary outcomes

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

    Time frame: 72hour

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

    Time frame: 24hour

  3. • Total 24 hours analgesic consumption.

    Time frame: 24hour

  4. • Time for block performance.

    Time frame: 30min

  5. • Dermatomal block effect.

    Time frame: 24hour

  6. inspiratory volumes (mL) measured with a volume incentive spirometer.

    Time frame: 72hour

  7. respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.

    Time frame: 3 days

  8. • Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.

    Time frame: 3days

Study contacts

Contact information is provided by the study sponsor or research team.

aya yassien, MD

CONTACT

[email protected]

01096577262

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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