NCT06757803

Brief Summary

Rib fractures are a common injury, occurring in up to 10% of all trauma patients. Multiple rib fractures can be particularly painful and debilitating, making it difficult for patients to breathe and cough. This can lead to complications such as atelectasis, pneumonia, and respiratory failure. Adequate pain control is essential for patients with rib fractures. This can help to improve respiratory function, reduce the risk of complications, and speed up recovery. Paravertebral block (PVB) is a regional anaesthetic technique that is commonly used for pain management in patients with rib fractures. It involves injecting local anaesthetics into the paravertebral space, which is a region of tissue located between the transverse processes of the vertebrae and the pleura. PVB is an effective way to block the sensory nerves that supply the thoracic region, including the ribs. However, PVB can be technically challenging to perform, and there is a risk of complications such as pneumothorax and pleural puncture. Retrolaminar block (RLB) is a newer regional anaesthetic technique that has been proposed as an alternative to PVB for pain management in patients with rib fractures. RLB involves injecting local anaesthetics into the retrolaminar space, which is a region of tissue located between the lamina of the vertebra and the epidural space. RLB is thought to be easier to perform than PVB, and there is a lower risk of complications. However, there is limited studies support the use of RLB for pain management in patients with rib fractures. The primary objective of this research is to compare the analgesic efficacy of retrolaminar block (RLB) and paravertebral block (PVB) in patients with fracture ribs. Secondary objectives include:

  • To compare the safety of RLB and PVB
  • To compare the duration of analgesia provided by RLB and PVB

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 26, 2024

Last Update Submit

December 19, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • total post operative analgesic consumption

    total analgesic consumption in 1st 48hours

    48 hours

Study Arms (2)

group 1

EXPERIMENTAL

patients will be subjected to rertrolaminar block

Procedure: rertrolaminar block

group 2

EXPERIMENTAL

patients will be subjected to paravertebral block

Procedure: paravertebral block

Interventions

Positioning The patient is positioned in a lateral decubitus position with the affected side up. The patient's arm on the affected side is placed behind the head. The patient's spine is aligned and the shoulder is elevated to expose the paravertebral space. \*Ultrasound imaging A high-frequency linear ultrasound probe (5-12 MHz) is placed in a paramedian sagittal plane at the desired level of block. The probe is oriented so that the transverse processes are visualized on the lateral side of the screen and the vertebral laminae are visualized on the medial side of the screen. The interlaminar space is visualized as a hypoechoic region between the laminae. \*Needle insertion A short bevel block needle (20-22 G) is inserted through the skin at the caudal end of the ultrasound probe, aiming cephalad. The needle is advanced under real-time ultrasound guidance until the tip of the needle contacts the lamina. The needle is then slightly withdrawn and the local anesthetic is injected into t

group 1

* Patient Preparation * Place the patient in the lateral decubitus position with the side of the block facing up. * Position the patient's arm so that it is resting comfortably on the operating table. * Prepare the skin over the block site with an antiseptic solution. * Sterilely drape the area. * Ultrasound Imaging * Place the ultrasound probe in a transverse plane at the level of the desired block. * Identify the following anatomical landmarks: * Vertebral body * Transverse process * Pleura * Intercostal space * Needle Insertion Use a sterile ultrasound-guided needle. Insert the needle in-plane from a lateral to medial direction, aiming for the apex of the paravertebral space. The needle should be advanced until it is just beyond the transverse process. \*Test Aspiration Aspirate to ensure that the needle is not in a blood vessel. * Local Anesthetic Injection * Inject the local anesthetic slowly, aspirating frequently. * The local anesthetic should be injected int

group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \* Age 18 years or older
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Rib fractures, as confirmed by X-ray or computed tomography (CT) scan
  • Both sexes, males and females.

You may not qualify if:

  • \*Patient refusal.
  • Infection at the injection site
  • Allergy to local anesthetics
  • Neurological deficit
  • Spinal deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (1)

  • Kotze A, Scally A, Howell S. Efficacy and safety of different techniques of paravertebral block for analgesia after thoracotomy: a systematic review and metaregression. Br J Anaesth. 2009 Nov;103(5):626-36. doi: 10.1093/bja/aep272.

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesThoracic Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

December 12, 2024

Primary Completion

December 2, 2025

Study Completion

December 19, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations