Ultrasound- Guided Continuous Retro Laminar Block Versus Continuous Erector Spinae Plane Block in Multiple Rib Fractures

NCT06088836 | Completed

• 1 other identifier: 36264MD35/2/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retrolaminar Block; Erector Spinae Plane Block; Spirometry; Pain; Multiple Rib Fractures

Outcome Measures

Primary Outcomes (1)

• Maximum inspired volume

  Maximum inspired volume will be measure by incentive spirometry which indicate less pain. Inspiratory capacity (IC) measured by Incentive Spirometry before the block, 30 minutes, 60 minutes after the blocks and then every six hours for subsequent 4 days.

  4 days after intervention.

Secondary Outcomes (9)

• Daily and total rescue analgesics consumption.

  24 hours after intervention.

• Intensive care length of stay.

  28 days after intervention

• Hospital length of stay.

  28 days after intervention

• pH

  4 days after intervention.

• PaO2

  4 days after intervention.

Study Arms (2)

Group I (Retrolaminar block group)

EXPERIMENTAL

Patients received ultrasound guided Retrolaminar block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

Drug: Retrolaminar block group

Group II (Erector spinae plane block group)

EXPERIMENTAL

Patients received ultrasound guided Erector spinae plane block bolus dose of 20 ml 0.25% bupivacaine then continuous infusion at a rate of 0.1 mL/kg/hr. for 4 days

Drug: Erector spinae plane block group.

Interventions

Retrolaminar block group DRUG

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.

Group I (Retrolaminar block group)

Erector spinae plane block group. DRUG

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

Group II (Erector spinae plane block group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years old.
• Both sexes.
• Patients with unilateral multiple traumatic rib fractures (≥ 3 ribs).

You may not qualify if:

• st 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesia, Surgical ICU and Pain Medicine Master's degree of Anesthesia, Surgical ICU And Pain Medicine

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 18, 2023
• Study Start: October 18, 2023
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)