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 )

NCT ID: NCT06981728

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-09-30

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]

Conditions

Rib Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

M (MTPB)

Mid-point transverse to pleura block

Group Type: ACTIVE_COMPARATOR

Mid point transverse to pleura block

Intervention Type: 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.

P (TPVB)

Thoracic paravertebral block

Group Type: SHAM_COMPARATOR

Mid point transverse to pleura block

Intervention Type: 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.

Interventions

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 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.

Intervention Type: PROCEDURE

Other Intervention Names

Thoracic paravertebral block

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aya Yassien Mahmoud Ahmed

MD doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

alaa attia, professor

Role: STUDY_DIRECTOR

alaaguhina@aun.edu.eg

Monira Ismail, professor

Role: STUDY_DIRECTOR

Monira.taha77@med.suez.edu.eg

muhamed mamdouh, lecturer

Role: STUDY_DIRECTOR

mamdouh372@med.aun.edu.eg

Central Contacts

aya yassien, MD

Role: CONTACT

aya.yassien1994@gmail.com

01096577262

Related Links

https://goo.gl/MTv7ea

Related Info

https://goo.gl/AeNXBz

Related Info

Other Identifiers

fracture ribs

Identifier Type: -

Identifier Source: org_study_id