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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 )

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 )

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06981728
Enrollment
70
Registered
2025-05-21
Start date
2025-06-30
Completion date
2027-09-30
Last updated
2025-05-21

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

Conditions

Rib Fractures

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.

Detailed description

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.\[5\]

Interventions

PROCEDUREMid point transverse to pleura block

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.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Time for first analgesic request. • Total 24 hours analgesic consumption.24hour
• Total 24 hours analgesic consumption.24hour
• Time for block performance.30min
• NRS scores at different times up to 24 hours.72hour
inspiratory volumes (mL) measured with a volume incentive spirometer.72hour
respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.3 days
• Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.3days
• Dermatomal block effect.24hour

Contacts

Primary Contactaya yassien, MD
aya.yassien1994@gmail.com01096577262

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026