EUCTR2018-001657-27-FI
Active, not recruiting
Phase 1
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 - SEpi
Not provided0 sites60 target enrollmentJuly 3, 2018
ConditionsMultiple traumatic rib fracturesTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsRopivacaine 2mg/ml
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Multiple traumatic rib fractures
- Sponsor
- Not provided
- Enrollment
- 60
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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