Comparison of ultrasound guided Serratus Anterior Plane Block (SAPB) with continuous local anesthetic infusion and epidural analgesia in the treatment of multiple rib fracture analgesia: a prospective, randomized clinical study

Phase 1

• Conditions: Multiple traumatic rib fractures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-001657-27-FI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-03
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

The patients who are concent to participate in the trial and have multiple unilateral traumatic rib fractures (at least 3 fractured ribs in one side, not only the three uppermost) and it is estimated that the patient benefits regional anesthetic techniques in analgesia in rest and movement (pain score in numeral rating scale = 4).
Age 18-75 years
Body mass index = 38
Spontaneously breathing patients
Normal consciousness
No traumatic brain injury
patient is not an abuser of narcotic substances or alcohol
patient has no allergies to local anesthetics and oxycodone
patient is not preagnant
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

The patient has a contraindication for either of the regional anesthetic techniques (epidural analgesia or serratus anterior plane block):
the most important contraindication are disturbed haemostasis, signs of infection in the area of regional anesthesia or generel infection and limitations in positionig the patient for the procedures. Patient with aortic valvulae stenosis are excluded.
Patient is not able to use PCA(patient controlled analgesia)-device or has a contraindication for it (lack of co-operation, dementia, patient is hemodynamically instable, has sleep apnea or history of abuse of drugs or alcohol)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to compare the effect of ultrasound guided serratus anterior plane block with continuous local anesthetic infusion with epidural analgesia in patients with multiple traumatic rib fractures;Secondary Objective: ....;Primary end point(s): Pain scores in NRS (numeral rating scale) in rest and movement;Timepoint(s) of evaluation of this end point: before regional analgesia (0 min), after 30 and 60 minutes, 2 hours, 12 hours, 1. and 2. day after the start of regional anesthesia

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): FEV1 (forced expiratory volume in one second) before regional analgesia in rest and movement(deep breathing) and the same measurments after 30 and 60 minutes, 2, 12 and 12 hours after regional anesthesia and day one and two after the procedure. <br> Blood pressure, heart rate, oxygen saturation are measured at the same time points than NRS and FEV 1.<br> PCA oxycodone consuption<br> ;<br> Timepoint(s) of evaluation of this end point: Before regional anesthesia (0 min) and after 30 and 60 minutes, 2, 12 and 12 hours after regional anesthesia and day one and two after the procedure. <br>