Clinical trial 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 )
Official title: 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 )
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rib Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.\[5\]

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.

Primary outcomes:
measure: 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.
timeFrame: 24hour
Secondary outcomes:
measure: • NRS scores at different times up to 24 hours.
timeFrame: 72hour
measure: Time for first analgesic request. • Total 24 hours analgesic consumption.
timeFrame: 24hour
measure: • Total 24 hours analgesic consumption.
timeFrame: 24hour
measure: • Time for block performance.
timeFrame: 30min
measure: • Dermatomal block effect.
timeFrame: 24hour
measure: inspiratory volumes (mL) measured with a volume incentive spirometer.
timeFrame: 72hour
measure: respiratory rate (RR),Heart rate (HR), Blood Pressure (BP), peripheral oxygen saturation (SpO2),and need for mechanical ventilation.
timeFrame: 3 days
measure: • Complications such as pneumothorax bradycardia hypotension. • development of pneumonia, hospital length of stay, and mortality.
timeFrame: 3days
Other outcomes:
Locations:
Study officials:
affiliation: alaaguhina@aun.edu.eg
name: alaa attia, professor
role: STUDY_DIRECTOR
affiliation: Monira.taha77@med.suez.edu.eg
name: Monira Ismail, professor
role: STUDY_DIRECTOR
affiliation: mamdouh372@med.aun.edu.eg
name: muhamed mamdouh, lecturer
role: STUDY_DIRECTOR
References: