Pain, Acute Clinical Trial
Official title:
A Retrospective Review of Rib Fracture Pain Management at a London Major Trauma Centre Comparing Erector Spinae Plane Blocks, Serratus Anterior Plane Blocks and Epidurals
Verified date | April 2021 |
Source | Imperial College Healthcare NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Thoracic epidural analgesia (TEA) is widely considered to be the current gold standard treatment for rib fracture pain and is used in the Imperial invasive treatment pathway for rib fractures. However, TEA are often contraindicated due to other injuries or the use of anticoagulant medications, which also contraindicates other invasive nerve block techniques e.g. paravertebral catheters. A number of case reports have reported the safe use of alternative techniques such as Serratus Anterior Blocks (SAPB) and Erector Spinae Blocks (ESPB) and the anaesthesia community has taken them up widely based on this relatively limited evidence. In view of this, Womack et al recently published a large retrospective review examining the safety and efficacy of ultrasound guided paravertebral catheter analgesia techniques in rib fracture management along with small numbers of ESPBs. However, this data did not report the analgesic efficacy, patient reported pain relief or respiratory complications.The goal is to advance this body of evidence by reviewing our larger data set concerning the use of TEA and alternative regional techniques such as ESPB and SAPB. This comprehensive review will benefit patients by documenting the efficacy and safety of these techniques for clinicians managing rib fracture patients.
Status | Completed |
Enrollment | 1500 |
Est. completion date | March 30, 2021 |
Est. primary completion date | March 4, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients aged > 18 years of age presenting with traumatic rib fractures in a major trauma centre over the past 5 years - Meet the criteria for the Imperial College Healthcare NHS Trust 'Invasive rib fracture management pathway' Exclusion Criteria: - Under 18 years old - Prisoners - Pregnant - Private patients - Meet the criteria for the Imperial College Healthcare NHS Trust 'Non-invasive rib fracture management pathway' |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Imperiial Collge Healthcare NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College Healthcare NHS Trust |
United Kingdom,
Adhikary SD, Liu WM, Fuller E, Cruz-Eng H, Chin KJ. The effect of erector spinae plane block on respiratory and analgesic outcomes in multiple rib fractures: a retrospective cohort study. Anaesthesia. 2019 May;74(5):585-593. doi: 10.1111/anae.14579. Epub — View Citation
Ahn Y, Görlinger K, Alam HB, Eikermann M. Pain-associated respiratory failure in chest trauma. Anesthesiology. 2013 Mar;118(3):701-8. doi: 10.1097/ALN.0b013e318283996b. — View Citation
Barnea Y, Kashtan H, Skornick Y, Werbin N. Isolated rib fractures in elderly patients: mortality and morbidity. Can J Surg. 2002 Feb;45(1):43-6. — View Citation
Jones KM, Reed RL 2nd, Luchette FA. The ribs or not the ribs: which influences mortality? Am J Surg. 2011 Nov;202(5):598-604. doi: 10.1016/j.amjsurg.2010.09.029. Epub 2011 Aug 26. — View Citation
Simon BJ, Cushman J, Barraco R, Lane V, Luchette FA, Miglietta M, Roccaforte DJ, Spector R; EAST Practice Management Guidelines Work Group. Pain management guidelines for blunt thoracic trauma. J Trauma. 2005 Nov;59(5):1256-67. — View Citation
Witt CE, Bulger EM. Comprehensive approach to the management of the patient with multiple rib fractures: a review and introduction of a bundled rib fracture management protocol. Trauma Surg Acute Care Open. 2017 Jan 5;2(1):e000064. doi: 10.1136/tsaco-2016 — View Citation
Womack J, Pearson JD, Walker IA, Stephens NM, Goodman BA. Safety, complications and clinical outcome after ultrasound-guided paravertebral catheter insertion for rib fracture analgesia: a single-centre retrospective observational study. Anaesthesia. 2019 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of patients with a reduction in pain | The investigators will review pain scores as recorded by clinical staff over 72 hours to assess pain relief efficacy, A verbal rating scale classifying pain as mild, moderate or severe is used at Imperial Data from the acute pain round records will also provide details regarding breathing comfort levels of the patient, coughing ability and deep inspiratory effort. These are recorded as yes/no answers and the team will assess the proportion of patients showing a reduction in pain scores. | 72 hours | |
Secondary | Opioid Type | Data regarding type of opiate use | 72 hours | |
Secondary | Opioid mode of delivery | Mode of delivery of opioids | 72 hours | |
Secondary | Opioid use | Dosage requirement every 24 hours for a total of 72 hours | 72 hours | |
Secondary | Opioid complication(s) | Complications associated with opiates such as constipation, delirium and respiratory depression. | 72 hours | |
Secondary | Nausea and vomiting | The incidence of nausea and vomiting pre-chest wall block | Time zero | |
Secondary | NUmber of nausea and vomiting episodes | The incidence of nausea in the 72 hours post block will be recorded with the number of episodes | 72 hours post block | |
Secondary | Anti-emetic(s) used | The incidence of nausea in the 72 hours post block will be recorded with the number of anti-emetic medications required to treat. | 72 hours post block | |
Secondary | Lower respiratory tract infections | Lower Respiratory Tract Infection (LRTI): for this study is defined as patients showing clinical features of chest infection including pyrexia (temperature >37.5°C), an increase in oxygen requirements from baseline, radiological evidence of chest infection or antimicrobial treatment of an LRTI started by the treating team. | Length of stay up 8 weeks | |
Secondary | Respiratory complication(s) | Empyema/Parapneumonic effusions: defined as radiological evidence of fluid collections within the pleural space and therapeutic interventions required for treatment e.g. aspiration and drainage. | Length of stay up to 8 weeks | |
Secondary | Intensive care admission for respiratory complications | ICU admission for respiratory complications | Length of stay up to 8 weeks | |
Secondary | Intensive care admission | Number of patients requiring intubation and ventilation | Length of stay up to 8 weeks | |
Secondary | Intensive care mechanical ventilation | Number of days of mechanical ventilation | Length of stay up to 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05396820 -
Adaptation of the Motor System to Experimental Pain
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Recruiting |
NCT06350084 -
Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05458037 -
RCT of Pain Perception With Fast and Slow Tenaculum Application
|
N/A | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Completed |
NCT06005480 -
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT04850079 -
EHR Precision Drug Treatment in Neonates
|
||
Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
Recruiting |
NCT05383820 -
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
|
Phase 4 | |
Completed |
NCT04851353 -
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
|
N/A | |
Completed |
NCT03280017 -
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
|
Phase 4 | |
Completed |
NCT04280796 -
Changes in Affective Pain Processing in Human Volunteers
|
N/A | |
Not yet recruiting |
NCT04523623 -
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
|
N/A | |
Not yet recruiting |
NCT04491630 -
COping With PAin Through Hypnosis, Mindfulness and Spirituality
|
N/A | |
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Withdrawn |
NCT03137017 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
|
Phase 1 | |
Withdrawn |
NCT03137030 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
|
Phase 1 | |
Completed |
NCT04659395 -
How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block
|
N/A |