Parascapular Sub Iliocostalis Plane Block Versus Thoracic Paravertebral Plane Block for Traumatic Multiple Rib Fractures

NCT07493473 | Recruiting

• 1 other identifier: ZU-IRB #1139
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pain control of rib fractures is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia which increase the hospital stay, as well as the transition to chronic pain. The cornerstones of analgesic management are oral and intravenous medications such as paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids as well as regional block techniques as paravertebral block and thoracic epidural. To avoid opioid as well as regional block related side effects such as pneumothorax and hemodynamic instability, previous studies showed that superficial chest wall block such as thoracic erector spinae plane block and serratus anterior plane block had shown a promising success in management of such pain with few side effects. In an effort to reduce the pain score, hospital stay and improve the patient's capability of physiotherapy this study compares continuous block of parascapular sub-iliocostalis plane block versus continuous thoracic paravertebral block for analgesia in patients with traumatic multiple rib fractures.

Conditions

Discitis of Thoracic Region

Keywords

Paravertebral block

Outcome Measures

Primary Outcomes (1)

• pain intensity using VAS.

  Patients will be instructed to evaluate pain scores by visual analog scale (VAS), which is a simple assessment tool consisting of a 10-cmline, where 0=no pain at all, 1-2=mild pain intensity,3-5=moderate pain intensity, 6-8=severe pain intensity, and 9-10=worst pain was felt.

  VAS score will be recorded just before analgesia, post block at hour1, hour12 , hour24 and hour48 at rest and on coughing.

Secondary Outcomes (4)

• inspiratory exercise tolerance by using Hand-held volume targeted incentive spirometry

  immediately before analgesia, post block at hour1, hour12, hour24 and hour48

• peak expiratory flow rate

  immediately before analgesia, post block at hour1, hour12, hour24 and hour48

• Patient satisfaction

  at hour 48

• amount of total opioid consumption

  in 48 hours in block groups starting from the beginning of the local anesthetic block.

Study Arms (2)

Group 1 (TPV)

ACTIVE COMPARATOR

patients will receive ultrasound guided continuous thoracic paravertebral nerve block

Procedure: Thoracic paravertebral block

Group 2 (PSIB)

ACTIVE COMPARATOR

patients will receive ultrasound-guided continuous parascapular subiliocostalis plane block

Procedure: Parascapular Sub-Iliocostalis Plane Block

Interventions

Thoracic paravertebral block PROCEDURE

Site of injection is two segments below the most cephalad fractured rib. The midpoint of the transducer is placed in a longitudinal paramedian plane between two transverse processes of chosen vertebral level. An 18 G needle is introduced using out of plane . The tip of the needle is advanced under vision till it pierces the superior costotransverse ligament. 5 ml of bupivacaine 0.25% is injected after negative aspiration, while the spread of local anaesthetic and simultaneously anterior pushing of the pleura is observed Afterwards an additional 10 ml bupivacaine 0.25% with one μg per kg of fentanyl is injected. A catheter is threaded 2-3 cm into the paravertebral space after the block. The distance travelled by needle is noted. A perioperative elastomeric infusion of 0.125 percent bupivacaine begins at a rate of 5 ml/h via the paravertebral catheter and maintained for a duration of 48 hours.

Group 1 (TPV)

Parascapular Sub-Iliocostalis Plane Block PROCEDURE

While seated with arms draped over body, the patient will receive the PSIB. A linear ultrasound probe is positioned in a parasagittal plane, at the level of the scapular spine edge, 2 cm from the medial scapular border (fourth rib level). An examination of the trapezius, rhomboid major, iliocostalis, and intercostal muscles is conducted, encompassing both the superficial and deep layers of muscle tissue. By employing an in-plane method, a sono-visible 100 mm 18 G needle is inserted in the vicinity of the fourth rib with a cranial to caudal orientation. The needle is then advanced in the iliocostal-intercostal myofascial plane. Following the confirmation of the needle's position, a catheter is inserted 6 cm beyond the needle tip and tunneled beneath the skin. 15 ml of 0.25 percent bupivacaine is injected. Then, a perioperative elastomeric infusion of 0.125 percent bupivacaine begins at a rate of 5 ml/h via the PSIB catheter and will be maintained for a duration of 48 hours.

Group 2 (PSIB)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient written informed consent.
• ASA I to III.
• Age 21-60 years old.
• Gender: Both.
• BMI \< 35 Kg/M2.
• Accepted mental state of the patient.
• Patient with unilateral multiple rib fractures (≥2 fractures)

You may not qualify if:

• Any trauma in the patient that interfere with the positioning of patients for block.
• Patients who needed mechanical ventilation before or during the study.
• Patients with associated head trauma.
• Patient with hemodynamic instability and need inotropic support. • Patient with abbreviated injury scale (AIS) in extremity more than 2 (10)
• Pathological coagulopathy.
• Infection at the injection site.
• Disturbed conscious level.
• An allergy to local anesthetics or any used drugs in this study.
• Pregnancy.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, Sharqia Province, 44111, Egypt

RECRUITING

Study Officials

• A A El Malky, MD

  Zagazig University

  STUDY DIRECTOR

Central Study Contacts

R A Kamel, MD

CONTACT

+201229927122; ranion8598@gmail.com

D A Abo El Naga, MSC

CONTACT

+201022274433

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 25, 2026
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: August 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)