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

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ClinicalTrials.gov Identifier: NCT03919916
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
St George's University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracic Injuries Rib Fractures Anaesthesia, Local Levobupivacaine Analgesia, Patient-Controlled Pain Procedure: Serratus plane block Other: Patient controlled analgesia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : May 10, 2022
Estimated Study Completion Date : June 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Experimental

Other: Patient controlled analgesia
Computerised pump device facilitating the patient self administration and titration as needed of morphine
Other Name: 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 Name: Active comparator


Outcome Measures
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Primary Outcome Measures :
  1. Static visual analogue score (0-10) at 1 hour [ Time Frame: Measured at 1 hour ]
    Defined as pain score at rest


Secondary Outcome Measures :
  1. Dynamic visual analogue score (0-10) [ Time Frame: Measured at 1 hour, 24, 48 and 72 hours ]
    Defined as pain score on deep inspiration

  2. Static visual analogue score (0-10) [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as pain score at rest

  3. Morphine consumption [ Time Frame: Measured at 24, 48 and 72 hours ]
    Amount of intravenous morphine consumed within each 24 hour period

  4. Peak expiratory flow rate [ Time Frame: Measured at 1, 24, 48 and 72 hours ]
    Calculated as a percentage of predicted

  5. 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

  6. Incidence of hypotension [ Time Frame: Measured at 24, 48 and 72 hours ]
    Defined as a systolic blood pressure less than 90 mmHg

  7. 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

  8. 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

  9. Occurence of pneumonia [ Time Frame: Within 30 days ]
    Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.

  10. Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919916


Contacts
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Contact: Robert J Pilling, MB ChB FRCA 02033158000 ext 58026 Robert.Pilling@chelwest.nhs.uk
Contact: Damon Foster 02033156825 ext 58026 damon.foster1@nhs.net

Locations
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United Kingdom
Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Contact: Research Delivery Operations Manager    020 3315 6825    chelwest.research@nhs.net   
Contact: Robert Pilling, MB ChB FRCA       robert.pilling1@nhs.net   
Principal Investigator: Robert Pilling, MB ChB FRCA         
Sponsors and Collaborators
Chelsea and Westminster NHS Foundation Trust
St George's University Hospitals NHS Foundation Trust
Investigators
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Study Chair: Damon Foster Chelsea and Westminster NHS Foundation Trust
More Information
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Publications:

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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03919916    
Other Study ID Numbers: C&W19/007
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Thoracic Injuries
Wounds and Injuries