Pain Clinical Trial
— COPEOfficial title:
Comparison of Serratus Plane Block With Parenteral Opioid Analgesia Versus Patient Controlled Analgesia Alone in Acute Rib fracturEs
NCT number | NCT03919916 |
Other study ID # | C&W19/007 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 28, 2021 |
Est. completion date | June 10, 2022 |
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.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | June 10, 2022 |
Est. primary completion date | May 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Chelsea and Westminster Hospital, Chelsea and Westminster Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Chelsea and Westminster NHS Foundation Trust | St George's University Hospitals NHS Foundation Trust |
United Kingdom,
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* Note: There are 35 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Static visual analogue score (0-10) at 1 hour | Defined as pain score at rest | Measured at 1 hour | |
Secondary | Dynamic visual analogue score (0-10) | Defined as pain score on deep inspiration | Measured at 1 hour, 24, 48 and 72 hours | |
Secondary | Static visual analogue score (0-10) | Defined as pain score at rest | Measured at 24, 48 and 72 hours | |
Secondary | Morphine consumption | Amount of intravenous morphine consumed within each 24 hour period | Measured at 24, 48 and 72 hours | |
Secondary | Peak expiratory flow rate | Calculated as a percentage of predicted | Measured at 1, 24, 48 and 72 hours | |
Secondary | Level of sedation | 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 | |
Secondary | Incidence of hypotension | Defined as a systolic blood pressure less than 90 mmHg | Measured at 24, 48 and 72 hours | |
Secondary | Incidence of nausea and vomiting | Assessed using the Nausea-Vomiting Scale (1-4) and lower values are considered a better outcome | Measured at 24, 48 and 72 hours | |
Secondary | Incidence of respiratory depression | Defined as a respiratory rate of less than 12 breaths per minute | Measured at 24, 48 and 72 hours | |
Secondary | Occurence of pneumonia | Defined as occurence of in-hospital pneumonia from admission to discharge of this hospitalisation. | Within 30 days | |
Secondary | Hospital length of stay | Defined as the number of days the patient stayed in hospital | Up to 6 months |
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