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

Primary Purpose

Anesthesia, Rib Fractures

Status
Suspended
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Serratus Anterior Plane Catheter
Thoracic Epidural Catheter
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia focused on measuring regional anaesthesia, rib fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Serratus Anterior Plane Catheter

Thoracic Epidural

Arm Description

Outcomes

Primary Outcome Measures

intravenous morphine use via a patient controlled pump
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

static and dynamic pain scores measurements
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.
side effects/ complications of interventions
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.
spirometry
Spirometry will be undertaken at the bedside and the tidal volumes will be recorded 3 times and the average taken of the 3 measurements.
quality of recovery assessment
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.

Full Information

First Posted
October 8, 2018
Last Updated
October 12, 2022
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03711812
Brief Title
Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
Acronym
SABRE
Official Title
SABRE: Serratus Anterior Block and Catheter Use in Rib Fractures in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Covid-19
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Rib Fractures
Keywords
regional anaesthesia, rib fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serratus Anterior Plane Catheter
Arm Type
Active Comparator
Arm Title
Thoracic Epidural
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Serratus Anterior Plane Catheter
Intervention Description
Insertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion
Intervention Type
Procedure
Intervention Name(s)
Thoracic Epidural Catheter
Intervention Description
Insertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion
Primary Outcome Measure Information:
Title
intravenous morphine use via a patient controlled pump
Description
This will be measured as the total amount (in milligrams) of intravenous morphine used via a patient controlled pump in 72 hours.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
static and dynamic pain scores measurements
Description
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.
Time Frame
72 hours
Title
side effects/ complications of interventions
Description
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.
Time Frame
72 hours
Title
spirometry
Description
Spirometry will be undertaken at the bedside and the tidal volumes will be recorded 3 times and the average taken of the 3 measurements.
Time Frame
72 hours
Title
quality of recovery assessment
Description
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.
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients aged over 18 years suffering 2 or more rib fractures Exclusion Criteria: Significant renal dysfunction (baseline creatinine >150μmol/l - morphine contra- indicated) Pregnancy Patients with chronic pain on regular analgesic medication Patients with significant coagulation abnormality (unsafe to site blocks) Participation in another interventional study that will interact with this trial. Patients unable to give informed consent Hypersensitivity to local anaesthetic (or any other study drug). Contraindication to NSAID (peptic ulceration or sensitive asthma) Weight <50kg
Facility Information:
Facility Name
Imperial College Healthcare NHS Trust
City
London
Country
United Kingdom

12. IPD Sharing Statement

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

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