Ultrasound-guided Serratus Block and the Emergence of Post-thoracotomy Pain Syndrome

Thoracic Neuritis Clinical Trial

Official title:

The Impact of Ultrasound-guided Serratus Anterior Plane Catheter Block (SAPB) Following Thoracotomy for Chest Malignancies on the Emergence of Post-thoracotomy Pain Syndrome (PTPS): A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533426
• Other study ID #: Raafat-Ehab.serratus
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: July 15, 2018

Study information

• Verified date: July 2018
• Source: National Cancer Institute, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective, single blinded, comparative pilot study is to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post - thoracotomy pain syndrome (PTPS). The investigator's assumed hypothesis is that; SAPB is an effective thoracic analgesic technique that may reduce the development of PTPS.

Description:

Lung cancer has the highest incidence of all malignancies worldwide & represents about 13% of all cancer victims. Lung cancer still represents the first cause of cancer deaths and lung resection surgeries could be the main therapeutic procedure. Hence, the number of thoracotomies is progressively increasing with more & more post- thoracotomy pain . Together with amputation, thoracotomy is considered the main etiology of severe & long-term acute and chronic post-surgical pain syndromes (CPSP). The prevalence of post - thoracotomy pain syndrome (PTPS) is variable (30-50%). The international association for the study of pain (IASP) has defined PTPS as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure".Besides, PTPS is mostly described with neuropathic manifestations along the thoracotomy scar, mammary & submammary ipsilateral scapular & interscapular areas. Pain is often aching, burning with tingling, numbness, pruritis plus sensory loss and/or hypoesthesia.Preemptive post-thoracotomy analgesia is mostly multimodal & integrates both systemic & regional techniques. Systemic drugs (either given parenterally or through patient controlled - analgesia "PCA") include, NSAIDs, Cox - II inhibitors, paracetamol, opioids, ketamine (as N-methyl-D- aspartate blocker), gabapentins & pregabalin, selective serotonin re-uptake inhibitors and/or duloxetine .Regional analgesic techniques include thoracic epidural analgesia (TEA) which, is considered by many as the gold standard analgesic mode for post-thoracotomy pain .Other regional analgesic techniques are paravertebral analgesia (PVB), intercostal nerve blocks and intrapleural analgesia.Recently SAPB has been practiced more widely as an U/S - guided, simple technique of effective post-thoracotomy analgesia which is comparable with standard techniques such as TEA and PVB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18y

• American Society of Anesthethiologists (ASA) physical status II or III .

• Patient will undergo thoracotomy for lung resection procedures (metastatectomy, segmentectomy lobectomy, pneumonectomy or pleuropneumonectomy).

Exclusion Criteria:

• Patients with history of drugs (opioids, L.A., NSAIDs) allergy.

• Morbid obese patients (BMI >40) .

• Major cardiorespiratory, hepatic, renal, endocrinal or hematological disorders.

• Patients on chronic analgesic therapy (daily morphine = 30 mg or equivalent dose of other opioids).

• History of drug abuse and neuropsychiatric diseases .

• History of thoracic cancer surgery within the last five years or patients having chest recurrence within 6 months.

• Patients having severe intra or post-operative bleeding or demanding postoperative ventilation will be also excluded from the study.

Related Conditions & MeSH terms

• Neuritis
• Thoracic Neuritis

Intervention

Procedure:
• Serratus anterior plane catheter block
Ultrasonographic guided placement of a catheter under the serratus anterior muscle in cases of open thoracotomies for chest malignancies in an attempt to reduce the emergence of postthoracotomy pain syndrome.
• Patient controlled analgesia
The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome

Locations

Country	Name	City	State
Egypt	Department of Anesthesia and Pain medicine.National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment for the possible emergence of post - thoracotomy pain syndrome .	The neuropathic PTPS cases are screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS having neuropathic component is grade 3 (probable) or 4 (definite) i.e GSNP =3 .	changes in 4 and 12 weeks .
Secondary	Assessment of patient daily activity and functional capacity.	Activity of daily living score (ADL score).It comprises 6 basic daily activities (feeding, toilet, bathing, dressing, grooming and walking) with each item is scored either 1= need no help, 2=need some help, 3=need complete help	changes in 4 and 12 weeks .
Secondary	Assessment of patient's quality of life.	Flanagan quality of life scale.A 16 items (domains) questionnaire with each item weights 1 to 7 points.the total score ranges from 16 to 112 .Higher values indicate better quality of life .It will be explained to the patients by the pain physician and the total score will be calculated and recorded	changes in 4 and 12 weeks .

External Links

•   preventing and treating pain after thoracic surgery