Clinical trial

Impact of Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block on Incentive Spirometry Volumes and Pain Scores in Multiple Rib Fractures

Name
36264MD35/2/23
Description
The aim of this study is to compare the incentive spirometry volume and analgesic efficacy of ultrasound guided continuous Retrolaminar block and continuous Erector spinae plain block in patients with multiple rib fractures.
Trial arms
Trial start
2023-10-18
Estimated PCD
2024-04-01
Trial end
2024-04-01
Status
Recruiting
Treatment
Retrolaminar block group
Under complete aseptic precautions and sterilization and in sitting position, A high-frequency linear ultrasound probe (6-11 MHz) was placed into a longitudinal orientation in the paraspinous line 1 cm from the midline. Lamina appeared as a continuous line interrupted by the intra laminar spaces. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done Then, an 18-gauge Tuohy needle was inserted in plane 1 cm lateral to the spinous process using ultrasound imaging and advanced caudally or cranially until it contacts the lamina.
Arms:
Group I (Retrolaminar block group)
Erector spinae plane block group.
Under complete aseptic precautions and sterilization and in sitting position, A high-frequency ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the midline midway between the uppermost and the lowest fractured rib to identify counting of ribs using ultrasound three muscles were identified as superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. However, when the rhomboid major muscle disappears this indicates that we are at the level of the seventh thoracic vertebra. local infiltration of needle insertion site with 3ml of 2.0 % lidocaine was done. Then, an 18-gauge Tuohy needle was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles
Arms:
Group II (Erector spinae plane block group)
Size
60
Primary endpoint
Maximum inspired volume
4 days after intervention.
Eligibility criteria
Inclusion Criteria: * Age from 18 to 65 years old. * Both sexes. * Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs). Exclusion Criteria: * 1st ken refusal. * Patients with any contraindication for regional block as: * Bleeding disorders. * Infection at the injection site. * Patients with hemodynamic instability. * Patients with known hypersensitivity to the study drugs * Unconscious patients * Patients with significant trauma outside the chest wall e.g., acute spine or pelvic fracture, severe traumatic brain or spinal cord injury, or abdominal visceral injuries * Patients with significant lung contusions, pneumothorax, flail chest * Chronic opioid users. * Uncooperative patients and patients with psychiatric illness
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}
Updated at
2023-10-19

1 organization

2 products

5 indications

Organization
Tanta University
Indication
Spirometry
Indication
Pain
Indication
Rib Fracture