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

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

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.

Study Overview

• Status: Suspended
• Conditions: Anesthesia; Rib Fractures
• Intervention / Treatment: Procedure: Serratus Anterior Plane Catheter; Procedure: Thoracic Epidural Catheter

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours
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.	72 hours
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.	72 hours
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.	72 hours

Collaborators and Investigators

• Sponsor: Imperial College London

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Anticipated): November 30, 2025
• Study Completion (Anticipated): November 30, 2025

Study Registration Dates

• First Submitted: October 8, 2018
• First Submitted That Met QC Criteria: October 16, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 12, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: regional anaesthesia; rib fractures
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease Attributes; Thoracic Injuries; Emergencies; Fractures, Bone; Rib Fractures
• Other Study ID Numbers: 232220

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No