Pain, Acute Clinical Trial
Official title:
Ultrasound-guided Deep Versus Superficial Continuous Serratus Anterior Plane Block for Pain Management in Patients With Multiple Rib Fractures: Randomized Double-blind Clinical Trial
Verified date | April 2024 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present clinical study will be undertaken to evaluate the effect of Ultrasound-guided Deep versus Superficial continuous Serratus Anterior Plane Block for pain management in patients with multiple rib fractures.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 10, 2023 |
Est. primary completion date | December 10, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Adult patients of either sex, having three or more unilateral fracture ribs and admitted to the trauma ICU, Rib fractures were confirmed by X-ray and CT scan reads. Exclusion Criteria: - significant head injury and unconsciousness (GCS less than 14) - Patients with significant pain from other injuries - pathological obesity (body mass index =35) - history of drug allergy local anesthetics - local infection at the injection site - inability to obtain consent from patient or surrogate, and patient refusal |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Beard L, Hillermann C, Beard E, Millerchip S, Sachdeva R, Gao Smith F, Veenith T. Multicenter longitudinal cross-sectional study comparing effectiveness of serratus anterior plane, paravertebral and thoracic epidural for the analgesia of multiple rib fractures. Reg Anesth Pain Med. 2020 May;45(5):351-356. doi: 10.1136/rapm-2019-101119. Epub 2020 Mar 11. — View Citation
Bhoi D, Selvam V, Yadav P, Talawar P. Comparison of two different techniques of serratus anterior plane block: A clinical experience. J Anaesthesiol Clin Pharmacol. 2018 Apr-Jun;34(2):251-253. doi: 10.4103/joacp.JOACP_294_16. No abstract available. — View Citation
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Piracha MM, Thorp SL, Puttanniah V, Gulati A. "A Tale of Two Planes": Deep Versus Superficial Serratus Plane Block for Postmastectomy Pain Syndrome. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):259-262. doi: 10.1097/AAP.0000000000000555. — View Citation
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain score | patient report numerical rating scale (NRS) 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable" | before and after the block at "30 minutes", "2hours", "4hours", "6hours", "12hours", "24hours", "36hours", "48 hours" & "72hours" | |
Secondary | Change in inspiratory volumes (mL) | Maximum inspiratory respiratory volume (measured in ml) recorded on single use of incentive spirometer device | before and after block at "90 minutes" then every "12hours" for 3 days | |
Secondary | change in Serum beta-endorphin level | We will use radioimmunoassays to measure plasma beta-endorphin level | before procedure and at 24 hours post procedure | |
Secondary | Lung Ultrasound Score (LUSS) | We will use a techniques based on the international evidence-based recommendations for point-of-care lung ultrasound that recommended using a complete eight-zone lung ultrasound ,The worst ultrasound pattern observed in each zone was recorded and used to calculate the sum of the scores (total score = 24). | before and after block at "90 minutes" then every "24 hours" for 3 days | |
Secondary | mean arterial blood pressure | mean arterial blood pressure by non invaisive blood pressure monitoring | before and after the block every "2hours" for 3 days | |
Secondary | heart rate | heart rate by EKG monitor | before and after the block every "2hours" for 3 days | |
Secondary | peripheral arterial oxygen saturation (SpO2) | measured by Pulse oximetry | before and after the block every "2hours" for 3 days |
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