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

NCT03711812 | Suspended

• 1 other identifier: 232220
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Rib Fractures

Keywords

regional anaesthesia; rib fractures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• static and dynamic pain scores measurements

  72 hours

• side effects/ complications of interventions

  72 hours

• spirometry

  72 hours

• quality of recovery assessment

  72 hours

Study Arms (2)

Serratus Anterior Plane Catheter

ACTIVE COMPARATOR

Procedure: Serratus Anterior Plane Catheter

Thoracic Epidural

PLACEBO COMPARATOR

Procedure: Thoracic Epidural Catheter

Interventions

Serratus Anterior Plane Catheter PROCEDURE

Insertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion

Serratus Anterior Plane Catheter

Thoracic Epidural Catheter PROCEDURE

Insertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion

Thoracic Epidural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Rib Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 18, 2018
• Study Start: November 5, 2018
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: October 14, 2022

Record last verified: 2022-10

Locations

GB (1)