Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs

Sponsor

Sohag University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05975294

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Rib fractures are common after blunt injury to the chest. Present in 10% of blunt trauma admissions. Pain associated with rib fractures can result in compromise of pulmonary function causing hypoxaemia or pneumonia, which may require mechanical ventilation. Adequate relief of rib fracture pain allows the patient to breathe deeply, avoid intubation and clear secretions effectively, which will minimise the pulmonary complications .

Pain control is essential for not only primary pain relief but also preventing secondary complications such as atelectasis or pneumonia as well as the transition to chronic pain. Accordingly, further steps are now being taken from the conventional pain control medication and techniques by the introduction of more aggressive pain control measures .Traditional regional anaesthesia (RA) techniques such as paravertebral, intercostal and epidurals injections are resource-intensive and time-consuming, limited to single dermatomes; provide incomplete analgesia of the hemithorax; and are associated with significant potential complications such as local anaesthetic intoxication, vasovagal syncope, hemi diaphragmatic paresis and pneumothorax .

The erector spinae plane block (ESPB) is a novel fascial plane block. Its use has been documented in numerous instances with positive outcomes in controlling acute as well as chronic pain. The most popular technique was the continuous infusion through a catheter . Fascial plane blocks that can be used for rib fracture pain management are serratus anterior plane block, erector spinae plane block and the rhomboid intercostal and subserratus (RISS) block. The procedure is more simple to use with a lower incidence of complications ,less time consuming , more superficial than others so it can be used in patients on anticoagulant therapy .

Providing analgesia for patients with rib fractures continues to be a management challenge. Therefore, further studies are needed comparing between different techniques to prove their efficacy in pain management

Condition or Disease	Intervention/Treatment	Phase
Multiple Fracture Ribs	Drug: amixture 0.125% bupivicaine with fentanyl Drug: 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prospective Comparative Study Between Ultrasound-guided Continuous Erector Spinae Plane Block and the Use of Intravenous Patient Controlled Analgesia for Management of Pain in Patients With Multiple Fracture Ribs

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group(E): including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.	Drug: amixture 0.125% bupivicaine with fentanyl ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.
Active Comparator: Group (C) including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.	Drug: 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Arm

Intervention/Treatment

Active Comparator: Group(E):

including 30 patients with multiple fracture ribs will undergo ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.

Drug: amixture 0.125% bupivicaine with fentanyl

ultrasound guided continuous erector spinae plane block with abolus 0.3ml /kg of amixture 0.125% bupivicaine with fentanyl of 2 mic per ml then Infusion of 0.1 ml /kg/hr of the same mixture.

Active Comparator: Group (C)

including 30 patients with multiple fracture ribs will be given intravenous PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Drug: 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset

PCA device of 100 ml volume containing 80 mg of nalbuphine ,180 mg ketorolac, 24mg dexamethasone, 16 mg danset and normal saline at a rate of 2 ml/h.

Outcome Measures

Primary Outcome Measures

• Pulmonary function to evaluate mean change in incentive spirometry volume [1 year]
from pretreatment then 1 h after procedure then daily for 5days including: Forced expiratory volume in one second (FEV1) ,Forced vial capaciy (FVC) and The ratio of the two volumes(FEV1/FVC) and inspiratory capacity (IC).
• VAS pain score [1 year]
will be calculated pretreatment then at 0, 0.5h, 1h, 2h , 3h ,6h, 12h and 24h thn daily for 5 days at rest and at movement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Age 18:60 years
Patient with 2 or more unilateral rib fractures.
ASA 1 , ASA 2

Exclusion Criteria:

• patient refusal
History of chronic pain or daily use of analgesics
History of psychiatric disorder or inability to understand the consent form or how to use a visual analog scale (VAS) for pain measurement
Severe renal or hepatic dysfunction
Allergy to any required drug
Second thoracic surgery
Local infection at the injection site
Spinal deformity
head injury
lung complications related to trauma ( pneumothorax , haemothorax , lung collapse).
need of mechanical ventilation