Ultrasound- Guided Continuous Serratus Anterior Plane Block Versus Ultrasound- Guided Continuous Thoracic Paravertebral Block in Multiple Traumatic Rib Fractures.

NCT04710823 | Completed

• 1 other identifier: 32596/09/18
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic efficacy of ultrasound guided continuous SAP block and ultrasound guided continuous TPVB in patients with multiple traumatic rib fractures.

Conditions

Serratus Anterior Plane Block; Thoracic Paravertebral Block; Ultrasound; Multiple Traumatic Rib Fractures; Analgesia

Outcome Measures

Primary Outcomes (1)

• Degree of pain scores

  Pain will be assessed at rest and on coughing using the VAS on a scale from 0 (no pain) to 100 (worst pain) before the block, 30 minutes, 60 minutes after the block, and then every six hours for 4 days. But in order not to interrupt the sleeping pattern of patients, patients will be considered pain free (VAS= 0) if they will be at sleep with no tachypnea, tachycardia, or hypertension.

  Four days after the block

Secondary Outcomes (7)

• Total consumption of morphine

  Four days after the block

• Changes of forced vital capacity (FVC)

  Four days after the block

• Changes of forced expiratory volume in one second (FEV1)

  Four days after the block

• Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)

  Four days after the block

• Length of ICU stay

  Four days after the block

Study Arms (2)

Thoracic paravertebral block

EXPERIMENTAL

Patients will receive ultrasound-guided continuous thoracic paravertebral blockusing bupivacaine 0.25% for 4 days.

Procedure: Thoracic paravertebral block

Serratus anterior plane block

EXPERIMENTAL

Patients will receive ultrasound-guided continuous SAP block using bupivacaine 0.25% for 4 days.

Procedure: Serratus anterior plane block

Interventions

Thoracic paravertebral block PROCEDURE

A bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days.

Thoracic paravertebral block

Serratus anterior plane block PROCEDURE

A bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days.

Serratus anterior plane block

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of either gender aged between 22-65 years with unilateral traumatic multiple fracture ribs (≥ 3 fractured ribs).

You may not qualify if:

• Contraindications to regional block such as patient's refusal, coagulopathy, local infection at the site of the block, known allergy to local anesthetic drugs and spinal deformity.
• Patients suffer from severe cardiovascular disease, hepatic or renal disease and patients with history of psychiatric illness.
• Patients had indications for mechanical ventilation on admission or during the study period.
• Patients had indications for immediate surgery for other associated injuries.
• Patients with hemodynamic instability.
• Patients having spine or pelvic fracture, traumatic brain injury, altered conscious level or spinal cord injury.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: January 16, 2021
• Primary Completion: April 25, 2021
• Study Completion: April 30, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After 3 months from the end of study and for one year

Locations

EG (1)