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

Primary Purpose

Thoracic Injuries, Rib Fractures, Anaesthesia, Local

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Serratus plane block

Patient controlled analgesia

About this trial

This is an interventional treatment trial for Thoracic Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Serratus plane block and patient controlled analgesia

Patient controlled analgesia only

Arm Description

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

Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes

Outcomes

Primary Outcome Measures

Static visual analogue score (0-10) at 1 hour

Defined as pain score at rest

Secondary Outcome Measures

Dynamic visual analogue score (0-10)

Defined as pain score on deep inspiration

Static visual analogue score (0-10)

Defined as pain score at rest

Morphine consumption

Amount of intravenous morphine consumed within each 24 hour period

Peak expiratory flow rate

Calculated as a percentage of predicted

Level of sedation

Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome

Incidence of hypotension

Defined as a systolic blood pressure less than 90 mmHg

Incidence of nausea and vomiting

Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome

Incidence of respiratory depression

Defined as a respiratory rate of less than 12 breaths per minute

Occurence of pneumonia

Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.

Hospital length of stay

Defined as the number of days the patient stayed in hospital

Full Information

NCT ID

NCT03919916

First Posted

April 8, 2019

Last Updated

May 28, 2021

Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

St George's University Hospitals NHS Foundation Trust

1. Study Identification

Unique Protocol Identification Number

NCT03919916

Brief Title

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

Acronym

COPE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Unknown status

Study Start Date

May 28, 2021 (Actual)

Primary Completion Date

May 10, 2022 (Anticipated)

Study Completion Date

June 10, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chelsea and Westminster NHS Foundation Trust

Collaborators

St George's University Hospitals NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Injuries, Rib Fractures, Anaesthesia, Local, Levobupivacaine, Analgesia, Patient-Controlled, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Serratus plane block and patient controlled analgesia

Arm Type

Experimental

Arm Description

Arm Title

Patient controlled analgesia only

Arm Type

Active Comparator

Arm Description

Patient controlled analgesia programmed with morphine to deliver on demand boluses of 1 mg and limited by a lockout time of 5 minutes

Intervention Type

Procedure

Intervention Name(s)

Serratus plane block

Other Intervention Name(s)

Experimental

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Patient controlled analgesia

Other Intervention Name(s)

Active comparator

Intervention Description

Computerised pump device facilitating the patient self administration and titration as needed of morphine

Primary Outcome Measure Information:

Title

Static visual analogue score (0-10) at 1 hour

Description

Defined as pain score at rest

Time Frame

Measured at 1 hour

Secondary Outcome Measure Information:

Title

Dynamic visual analogue score (0-10)

Description

Defined as pain score on deep inspiration

Time Frame

Measured at 1 hour, 24, 48 and 72 hours

Title

Static visual analogue score (0-10)

Description

Defined as pain score at rest

Time Frame

Measured at 24, 48 and 72 hours

Title

Morphine consumption

Description

Amount of intravenous morphine consumed within each 24 hour period

Time Frame

Measured at 24, 48 and 72 hours

Title

Peak expiratory flow rate

Description

Calculated as a percentage of predicted

Time Frame

Measured at 1, 24, 48 and 72 hours

Title

Level of sedation

Description

Assessed using the Ramsay Sedation Scale (1-6) and a value of 2 is considered the best outcome

Time Frame

Measured at 24, 48 and 72 hours

Title

Incidence of hypotension

Description

Defined as a systolic blood pressure less than 90 mmHg

Time Frame

Measured at 24, 48 and 72 hours

Title

Incidence of nausea and vomiting

Description

Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome

Time Frame

Measured at 24, 48 and 72 hours

Title

Incidence of respiratory depression

Description

Defined as a respiratory rate of less than 12 breaths per minute

Time Frame

Measured at 24, 48 and 72 hours

Title

Occurence of pneumonia

Description

Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation.

Time Frame

Within 30 days

Title

Hospital length of stay

Description

Defined as the number of days the patient stayed in hospital

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert J Pilling, MB ChB FRCA

Phone

02033158000

Ext

58026

Robert.Pilling@chelwest.nhs.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Damon Foster

Phone

02033156825

Ext

58026

damon.foster1@nhs.net

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Damon Foster

Organizational Affiliation

Chelsea and Westminster NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

SW10 9NH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Research Delivery Operations Manager

Phone

020 3315 6825

chelwest.research@nhs.net

First Name & Middle Initial & Last Name & Degree

Robert Pilling, MB ChB FRCA

robert.pilling1@nhs.net

First Name & Middle Initial & Last Name & Degree

Robert Pilling, MB ChB FRCA

12. IPD Sharing Statement

Plan to Share IPD

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

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