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Completed

NCT Number: NCT04710823

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

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.

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Key information

Conditions

Serratus Anterior Plane Block Agnosia Analgesia Multiple Traumatic Rib Fractures Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Thoracic Paravertebral Block Ultrasound

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Degree of pain scores

    Time frame: Four days after the block

    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.

Secondary outcomes

  1. Total consumption of morphine

    Time frame: Four days after the block

    Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) ≥ 40.

  2. Changes of forced vital capacity (FVC)

    Time frame: Four days after the block

    Forced vital capacity (FVC) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

  3. Changes of forced expiratory volume in one second (FEV1)

    Time frame: Four days after the block

    Forced expiratory volume in one second (FEV1) will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

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

    Time frame: Four days after the block

    FEV1/FVC ratio will be assessed using bedside spirometry before the block, 30 minutes, 60 minutes after the blocks, and then every eight hours for 4 days

  5. Length of ICU stay

    Time frame: Four days after the block

    Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.

  6. Length of hospital stay

    Time frame: Four days after the block

  7. Incidence of complications

    Time frame: Four days after the block

    Incidence of respiratory complications and mechanical ventilation

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Jan 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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