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Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department (SABRE)

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ClinicalTrials.gov Identifier: NCT03711812
Recruitment Status : Not yet recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

The main aim of this study is to determine whether Serratus Anterior Plane (SAP) blockade provides improved pain relief after rib fractures compared to epidural administration of local anaesthetic. The investigators aim to show that SAP catheters (SAPC) can be placed in more situations and are less operator-dependent then thoracic epidural anaesthesia (TEA). This reduces the waiting time required to achieve satisfactory analgesia in the patient. Optimal analgesia allows early respiratory physiotherapy and reduction in the complications of multiple rib fractures.

Pain from rib fractures is severe. The sensory nerves of the thoracic wall lie in the SAP and a single ultrasound-guided injection of local anaesthetic spreads widely and provides useful post-injury analgesia for several hours. If a catheter is left in the SAP, the nerve blockade can be maintained for several days.

Rib Fracture pain is traditionally treated with oral/ intravenous analgesics or TEA. Opiate analgesia via patient controlled analgesia (PCA) can work very well but it is associated with excessive sedation, constipation, nausea and vomiting. Continuous TEA is generally regarded as the gold standard but it demands monitoring by adequately trained ward staff and is commonly associated with high failure rates and increased risk of complications. SAPC has also been used when TEA and PCA were not desirable.

The primary outcome will be the amount of morphine analgesia required by the patient. Secondary outcomes will be pain scores (at rest and on movement), the side effects of morphine, complications of TEA/ SAPC, respiratory function changes and a quality of recovery assessment.

The control group will have an epidural block and catheter placed. The treatment group will have SAP blocks and catheters placed under ultrasound guidance. Both blocks will be tested to ensure good pain relief. To avoid potential confounding effects, oral painkillers will adhere strictly to the study protocol.


Condition or disease Intervention/treatment Phase
Anesthesia Rib Fractures Procedure: Serratus Anterior Plane Catheter Procedure: Thoracic Epidural Catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: SABRE: Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
Estimated Study Start Date : November 5, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Serratus Anterior Plane Catheter Procedure: Serratus Anterior Plane Catheter
Insertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion

Placebo Comparator: Thoracic Epidural Procedure: Thoracic Epidural Catheter
Insertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion




Primary Outcome Measures :
  1. intravenous morphine use via a patient controlled pump [ Time Frame: 72 hours ]
    This will be measured as the total amount (in milligrams) of intravenous morphine used via a patient controlled pump in 72 hours.


Secondary Outcome Measures :
  1. static and dynamic pain scores measurements [ Time Frame: 72 hours ]
    This will be measured using a visual analogue scale from 0(no pain) to 10(unbearable pain). The measurement will be done whilst the patient is at rest and again on movement.

  2. side effects/ complications of interventions [ Time Frame: 72 hours ]
    The side effects and complications of either a thoracic epidural or serratus anterior plane block will be recorded. This includes failure to establish the block and/or catheter, decreased blood pressure, neurological sequelae, nausea and vomiting and itching.

  3. spirometry [ Time Frame: 72 hours ]
    Spirometry will be undertaken at the bedside and the tidal volumes will be recorded 3 times and the average taken of the 3 measurements.

  4. quality of recovery assessment [ Time Frame: 72 hours ]
    The quality of recovery (QoR) will be assessed using the QoR40. The QoR-40 is a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged over 18 years suffering 2 or more rib fractures

Exclusion Criteria:

  1. Significant renal dysfunction (baseline creatinine >150μmol/l - morphine contra- indicated)
  2. Pregnancy
  3. Patients with chronic pain on regular analgesic medication
  4. Patients with significant coagulation abnormality (unsafe to site blocks)
  5. Participation in another interventional study that will interact with this trial.
  6. Patients unable to give informed consent
  7. Hypersensitivity to local anaesthetic (or any other study drug).
  8. Contraindication to NSAID (peptic ulceration or sensitive asthma)
  9. Weight <50kg

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03711812     History of Changes
Other Study ID Numbers: 232220
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
regional anaesthesia
rib fractures

Additional relevant MeSH terms:
Fractures, Bone
Emergencies
Rib Fractures
Wounds and Injuries
Disease Attributes
Pathologic Processes
Thoracic Injuries