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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 : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
St George's University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Chelsea and Westminster NHS Foundation Trust

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 Drug: Patient controlled analgesia Not Applicable

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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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : March 1, 2020


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

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




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. Occurrence of pneumonia [ Time Frame: Within 30 days ]
  10. Hospital length of stay [ Time Frame: Up to 6 months ]
    Defined as the number of days the patient stayed in hospital



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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:

  • Bilateral rib fractures
  • Clavicular fractures
  • Polytrauma
  • Sternal fracture or injury
  • Thoracic spine injury
  • Decreased Glasgow Coma Scale score
  • Dementia
  • Delirium or psychiatric illness
  • Chronic lung disease
  • Coagulopathy
  • End stage liver disease
  • 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
  • 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

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: Neel Desai, MB ChB FRCA 02033158000 ext 58026 Neel.Desai@gstt.nhs.uk

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 Sponsor Representative, Research Delivery Operations Manager, Chelsea and Westminster Hospital NHS Foundation Trust

Publications:

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Responsible Party: Chelsea and Westminster NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03919916     History of Changes
Other Study ID Numbers: C&W19/007
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
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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Agnosia
Fractures, Bone
Rib Fractures
Thoracic Injuries
Wounds and Injuries
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents