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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710823
• Other study ID #: 32596/09/18
• Status: Completed
• Phase: N/A
• Start date: January 16, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: January 2023
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2021
• Est. primary completion date: April 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Fractures, Bone
• Multiple Traumatic Rib Fractures
• Rib Fractures
• Serratus Anterior Plane Block
• Thoracic Paravertebral Block
• Ultrasound

Intervention

Procedure:
• Thoracic paravertebral block
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
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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total consumption of morphine	Rescue analgesia will be provided with morphine (0.05 mg/kg) intravenously if visual analogue score (VAS) = 40.	Four days after the block
Secondary	Changes of forced vital capacity (FVC)	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	Four days after the block
Secondary	Changes of forced expiratory volume in one second (FEV1)	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	Four days after the block
Secondary	Changes of forced expiratory volume in one second (FEV1)/forced vital capacity (FVC)	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	Four days after the block
Secondary	Length of ICU stay	Length of ICU stay, defined as the time from admission to ICU to time of transfer to the surgical ward.	Four days after the block
Secondary	Length of hospital stay		Four days after the block
Secondary	Incidence of complications	Incidence of respiratory complications and mechanical ventilation	Four days after the block