Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia in Rib Fractures (COPE)

May 28, 2021 updated by: Chelsea and Westminster NHS Foundation Trust

Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs

In this multicentre randomised controlled trial, adult patients with isolated chest trauma and two or more unilateral rib fractures will be randomised to either serratus plane block and patient controlled analgesia or patient controlled analgesia alone. Our primary outcome is the static visual analogue scale score at one hour.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Rib breaks, or fractures, can cause pain that can be very difficult to manage and can result in chest infection and death. Such pain can be managed with either systemic drugs like morphine, which are given by mouth or through the veins, or local anaesthetic techniques, which can numb the painful area. Use of systemic drugs is however limited by significant side effects and traditional local anaesthetic techniques have problems of their own. Epidural analgesia, where local anaesthetic is placed near the spine, can only be done by those with a high level of technical skill and cannot be performed in patients with spine injuries, positioning difficulties and clotting problems. Complications and side effects can be common and/or serious and include failure, fall in blood pressure, and nerve and spinal cord damage. More recently, there has been interest in a new local anaesthetic technique, serratus plane block. Serratus plane block is simple to learn and can be done without any need for repositioning of the patient. It avoids some of the complications and side effects related to other local anaesthetic techniques and is more easily looked after by nursing staff on the ward. In view of this, we are aiming to recruit 44 adults with isolated chest injury and two or more rib fractures on one side. Each patient will either receive a serratus plane block in conjunction with morphine through the veins or just morphine alone. Our main aim is to assess how bad the pain is at 1 hour, but we will also compare the pain score, morphine consumption, lung function, level of sleepiness, and the frequency of low blood pressure, nausea and vomiting and slow breathing over the first 72 hours, as well as the hospital length of stay and occurrence of lung infection within 30 days.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, SW10 9NH
        • Recruiting
        • Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Pilling, MB ChB FRCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Isolated chest trauma
  • Two or more unilateral rib fractures

Exclusion Criteria:

  • One unilateral rib fracture
  • Bilateral rib fractures
  • Flail chest
  • Clavicular fractures
  • Polytrauma
  • Sternal fracture or injury
  • Thoracic spine injury
  • GCS less than 15
  • Acute or chronic confusional state
  • Delirium or psychiatric illness
  • Chronic lung disease necessitating home nebulisers and/or oxygen
  • Coagulopathy, defined as a platelet count less than 100 x 109/l , PT >15 or APTT >38
  • End stage liver disease
  • Severe congestive cardiac failure
  • Significant renal failure, defined as a creatinine >150µmol/l
  • Local infection at potential site of SBP insertion
  • Pregnancy or breastfeeding
  • History of chronic pain or opioid dependence
  • Current chronic analgesic therapy, not to include paracetamol, NSAIDs and/or codeine
  • Requirement for tracheal intubation and mechanical ventilation
  • Allergy to local anaesthetics and/or opioids
  • Inability to control and self-administer opioids with PCA due to confusion, learning difficulties or poor manual dexterity
  • Unable to speak and/or understand English
  • Patients known to clinicians to be COVID-19 positive as determined by PCR or for whom there is a clinical suspicion that they might be COVID-19 positive will be excluded from the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serratus plane block and patient controlled analgesia

Initial local anaesthetic bolus of 0.4 ml/kg of 0.25% levobupivacaine. Subsequent continuous local anaesthetic infusion of 0.125% levobupivacaine

Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
Procedure: Serratus plane block
Placement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib
Other Names:
  • Experimental
Other: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Other Names:
  • Active comparator
Active Comparator: Patient controlled analgesia only
Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes
Other: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Other Names:
  • Active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Static visual analogue score (0-10) at 1 hour
Time Frame: Measured at 1 hour
Defined as pain score at rest
Measured at 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic visual analogue score (0-10)
Time Frame: Measured at 1 hour, 24, 48 and 72 hours
Defined as pain score on deep inspiration
Measured at 1 hour, 24, 48 and 72 hours
Static visual analogue score (0-10)
Time Frame: Measured at 24, 48 and 72 hours
Defined as pain score at rest
Measured at 24, 48 and 72 hours
Morphine consumption
Time Frame: Measured at 24, 48 and 72 hours
Amount of intravenous morphine consumed within each 24 hour period
Measured at 24, 48 and 72 hours
Peak expiratory flow rate
Time Frame: Measured at 1, 24, 48 and 72 hours
Calculated as a percentage of predicted
Measured at 1, 24, 48 and 72 hours
Level of sedation
Time Frame: Measured at 24, 48 and 72 hours
Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome
Measured at 24, 48 and 72 hours
Incidence of hypotension
Time Frame: Measured at 24, 48 and 72 hours
Defined as a systolic blood pressure less than 90 mmHg
Measured at 24, 48 and 72 hours
Incidence of nausea and vomiting
Time Frame: Measured at 24, 48 and 72 hours
Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome
Measured at 24, 48 and 72 hours
Incidence of respiratory depression
Time Frame: Measured at 24, 48 and 72 hours
Defined as a respiratory rate of less than 12 breaths per minute
Measured at 24, 48 and 72 hours
Occurence of pneumonia
Time Frame: Within 30 days
Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.
Within 30 days
Hospital length of stay
Time Frame: Up to 6 months
Defined as the number of days the patient stayed in hospital
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

St George's University Hospitals NHS Foundation Trust

Investigators

  • Study Chair: Damon Foster, Chelsea And Westminster Hospital NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2021

Primary Completion (Anticipated)

May 10, 2022

Study Completion (Anticipated)

June 10, 2022

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C&W19/007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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