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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-60
SponsorZagazig University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient written informed consent.

ASA I to III.

Age 21-60 years old.

Gender: Both.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Thoracic paravertebral block

    Procedure/Surgery

    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.

  • Parascapular Sub-Iliocostalis Plane Block

    Procedure/Surgery

    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.

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Group 1 (TPV)Active comparator 1 intervention
Group B: Group 2 (PSIB)Active comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

Patients will be asked to take five deep breaths through incentive spirometers then each breath will take one point and then points and inhaled volumes will be documented in a table (No. of breaths, tidal volume (600,900,1200, ml as marked on the spirometer)

Time frame
immediately before analgesia, post block at hour1, hour12, hour24 and hour48
2

peak expiratory flow rate

Assess respiratory functions by peak expiratory flow meter (PEFR)

Time frame
immediately before analgesia, post block at hour1, hour12, hour24 and hour48
3

Patient satisfaction

Degree of patient satisfaction will be assessed and recorded as follows: * 1.Completely satisfied * 2.Satisfied * 3.Neither satisfied nor unsatisfied * 4.Completely unsatisfied

Time frame
at hour 48
4

amount of total opioid consumption

total amount of opioid consumption in 48 hours in block groups starting from the beginning of the local anesthetic block will be recorded

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.