Clinical trial NCT05409144: Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
Official title: Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post-thoracotomy Pain Syndrome
Erector Spinae Plane Block
Serratus Anterior Plane Block
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.

Detailed description: Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.

The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.

The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.

Eligibility criteria: Inclusion Criteria:

* Age (18-65) Years
* Physical status American Society of Anesthesiologists Classification II, III
* Patients undergoing lobectomy through lateral thoracotomy
* Body mass index (BMI): (20-40) kg/m2

Exclusion Criteria:

* Patient refusal.
* Age \<18 years or \>65 years
* Body mass index (BMI) \<20 kg/m2 and \>40 kg/m2
* Known sensitivity or contraindication to drugs used in the study
* Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
* Pregnancy.
* Physical status American Society of Anesthesiologists Classification IV
* patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
* patients with a history of drug abuse
* patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
* patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
* All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
* Thoracic spine disorders or deformity.

Primary outcomes:
measure: Incidence of patients developing post-thoracotomy pain syndrome
timeFrame: 12 weeks postoperatively
Secondary outcomes:
measure: Morphine consumption
timeFrame: 48 hours Postoperatively
measure: Fentanyl consumption
timeFrame: Intraoperatively
measure: Post-thoracotomy pain syndrome severity
timeFrame: 12 weeks postoperatively
measure: Patient's Quality of life
timeFrame: 12 weeks postoperatively
measure: Postoperative Patient's activity level
timeFrame: 12 weeks postoperatively
measure: Heart rate
timeFrame: Intraoperatively
measure: Mean arterial blood pressure
timeFrame: Intraoperatively
measure: Nausea and vomiting
timeFrame: 24 hours postopertivley
measure: Post-operative pain
timeFrame: 24 hours postopratively
measure: Time taken till 1st rescue analgesic request
timeFrame: 24 hours postopratively
measure: Postoperative pulmonary complications
timeFrame: 24 hours postopratively
Other outcomes:
Locations:
Study officials:
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