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 )
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mid point transverse to pleura block.
- Who it may be relevant to
- Registry conditions: Rib Fractures. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Procedure Mid 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 wit
Primary outcome measures
- 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 outcome measures (8)
- • NRS scores at different times up to 24 hours. [Time frame: 72hour]
- Time for first analgesic request. • Total 24 hours analgesic consumption. [Time frame: 24hour]
- • Total 24 hours analgesic consumption. [Time frame: 24hour]
- • Time for block performance. [Time frame: 30min]
- • Dermatomal block effect. [Time frame: 24hour]
- inspiratory volumes (mL) measured with a volume incentive spirometer. [Time frame: 72hour]
- respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation. [Time frame: 3 days]
- • Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality. [Time frame: 3days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06981728 · fracture ribs