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

NCT ID: NCT03533426

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-27
• Study Completion Date: 2018-07-15

Brief 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.

Detailed 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.

Conditions

Thoracic Neuritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Pump based patient controlled analgesia

Analgesia is maintained using disposable silicon ballon pump "Accufuser" containing morphine 0.2 mg/ml, 8mg ondansetron plus and 180 mg ketorolac. The infusion rate is 5 ml / h and lockout interval of 15min. the hourly delivered morphine dose is 1-1.8 mg \& the pump is sufficient for about 60 hours according to patient response.

Group Type: ACTIVE_COMPARATOR

Patient controlled analgesia

Intervention Type: PROCEDURE

The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome

serratus anterior plane catheter block

Linear ultrasound transducer (superficial) 6-12 MHz is utilized to count the ribs up to 4th or 5 th rib in the mid-axillary line. Musculature of thoracic wall is identified sonographically,an echogenic needle "14-16 G, 100 mm" is inserted in plane with the U/S probe towards the plane deep to the serratus anterior muscle. Under real - time U/S, single shot of 20ml contrast medium "iohexol = omnipaque" 150 mg I2 / ml is injected to check the plane and level (T3-T8/9) of SAPB.A reinforced radiopaque catheter is threaded through the needle and its final position underneath the plane of serratus anterior muscle is confirmed fluoroscopically. 20ml 0.25% levobupivacaine (Chirocaine).Analgesia is maintained using 0.125% levobupivacaine infusion at a rate of 7-12 ml/h according to patient response.

Group Type: ACTIVE_COMPARATOR

Serratus anterior plane catheter block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Patient controlled analgesia

The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Ehab Hanafy Shaker

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab H Shaker, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute- Cairo University

Locations

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, , Egypt

Countries

Egypt

Related Links

http://anesthesiology.pubs.asahq.org/article.aspx?articleid=1923467

preventing and treating pain after thoracic surgery

Other Identifiers

Raafat-Ehab.serratus

Identifier Type: -

Identifier Source: org_study_id