Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS

Not Applicable

• Conditions: Erector Spinae Plane Block; Post-thoracotomy Pain Syndrome; Serratus Anterior Plane Block
• Interventions: Device: Serratus Anterior Plane Block; Procedure: Thoracic epidural infusion; Device: Erector Spinae Plane Block

• Registration Number: NCT05409144
• Lead Sponsor: National Cancer Institute, Egypt

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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-06-03
• Last Update Submitted: 2022-06-03
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08
• Study Start: 2022-06-20
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 111

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus Anterior Plane Block group	Serratus Anterior Plane Block	Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.
Thoracic epidural infusion group	Thoracic epidural infusion	Patients will receive thoracic epidural preoperative
Erector Spinae Plane Block group	Erector Spinae Plane Block	Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter

Primary Outcome Measures

Name	Time	Method
Incidence of patients developing post-thoracotomy pain syndrome	12 weeks postoperatively	The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP

Secondary Outcome Measures

Name	Time	Method
Heart rate	Intraoperatively	Heart rate will be recorded
Morphine consumption	48 hours Postoperatively	The total amount of morphine consumed postoperatively for 48 hours.
Fentanyl consumption	Intraoperatively	Total amount of fentanyl consumed intraoperative
Post-thoracotomy pain syndrome severity	12 weeks postoperatively	Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
Patient's Quality of life	12 weeks postoperatively	Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
Postoperative Patient's activity level	12 weeks postoperatively	Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
Mean arterial blood pressure	Intraoperatively	Mean arterial blood pressure will be recorded
Nausea and vomiting	24 hours postopertivley	Postoperative nausea and vomiting (PONV) will be recorded
Post-operative pain	24 hours postopratively	Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
Time taken till 1st rescue analgesic request	24 hours postopratively	The time till administration of first rescue analgesia will be recorded
Postoperative pulmonary complications	24 hours postopratively	Postoperative pulmonary complications will be recorded