Comparison of Edge Laminar Block and Serratus Posterior Superior Intercostal Plane Block for Postoperative Pain Management After VATS

NCT ID: NCT07073495

Last Updated: 2026-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-15
• Study Completion Date: 2025-12-15

Brief Summary

This prospective observational study aims to compare the effectiveness of Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in managing postoperative pain after Video-Assisted Thoracoscopic Surgery (VATS). The study will evaluate postoperative pain scores (VAS/NRS), opioid consumption, incidence of postoperative nausea and vomiting (PONV), additional analgesic requirements, and patient satisfaction between the two regional analgesic techniques. This research seeks to provide guidance for optimal postoperative pain management in VATS patients.

Detailed Description

Video-Assisted Thoracoscopic Surgery (VATS) is a widely used minimally invasive surgical method in thoracic surgery. However, it is known to cause moderate to severe postoperative pain, which can lead to significant respiratory complications such as atelectasis and pneumonia by inhibiting deep breathing and coughing. Inadequate pain control also increases sympathetic nervous system activity, potentially leading to tachycardia, hypertension, and increased myocardial oxygen consumption, especially in patients with cardiac conditions. Furthermore, delayed mobilization due to pain can increase the risk of deep vein thrombosis (DVT) and pulmonary embolism, while insufficient acute pain management may contribute to chronic postoperative pain syndrome. These issues highlight the critical need for effective postoperative pain management. While traditional methods like thoracic epidural analgesia (TEA) and thoracic paravertebral block (TPVB) exist, they are often invasive. In this context, interfascial block techniques such as Edge Laminar Block (ELB) and Serratus Posterior Superior Intercostal Plane Block (SPSIPB) emerge as safer and effective alternatives.

ELB effectively blocks both anterior and posterior branches of thoracic nerves, providing extensive dermatomal sensory loss. It is considered a safer alternative to TPVB due to a lower risk of damage to sensitive structures like the pleura or major vessels during needle placement. ELB has been shown to be effective in postoperative pain management and reducing opioid consumption in surgeries like VATS. SPSIPB, applied by injecting local anesthetic between the serratus posterior superior muscle and intercostal muscles, provides both anteroposterior and lateral thoracic analgesia, creating a broad sensory block area. Studies have reported that SPSIPB provides an effective sensory block between C3-T10 levels and significantly reduces postoperative pain scores.

Study Objectives:

The primary objective of this study is to compare the effectiveness of ELB and SPSIPB in postoperative pain management in patients undergoing VATS. The study will focus on the following specific aims:

To evaluate the effects of ELB and SPSIPB on postoperative pain scores (Visual Analog Scale/Numeric Rating Scale - VAS/NRS).

To compare the potential of both techniques in reducing postoperative opioid consumption.

To examine the incidence of postoperative nausea and vomiting (PONV). To assess secondary outcome measures such as the need for additional analgesics and patient satisfaction in the postoperative period.

This study aims to be one of the first prospective observational studies to directly compare the efficacy of ELB and SPSIPB. The results are expected to provide guidance for optimal postoperative pain management in VATS patients and contribute to a better understanding of the clinical role of these two techniques.

Study Design and Methodology:

This will be a prospective, observational, single-center study. Patient groups will be formed based on natural clinical practice, without randomization. No additional procedures, interventions, or treatment changes will be made to any patient within the scope of the study. All patients will be managed according to standard anesthesia protocols currently applied in the clinic, at the discretion of the responsible anesthesiologists. During the study period, patients undergoing VATS will receive the block protocol routinely preferred by the responsible anesthesiologists, and no intervention will be made by the researchers. This study will not implement a new protocol; rather, it involves prospectively recording data from an anesthesia pain management protocol that proceeds in its natural course.

Postoperative Follow-up:

Pain Assessment: Pain will be assessed using the Visual Analog Scale (VAS) at 1, 4, 12, and 24 hours postoperatively.

Opioid Consumption: The amount of opioid consumed within the first 48 hours will be recorded (as morphine equivalents).

Complications: Complications such as hypotension, pruritus, nausea, and vomiting will be monitored.

Mobilization: The time until first mobilization (sitting at bedside/walking) will be recorded.

Patient Satisfaction: Patient satisfaction and pain control will be monitored and recorded for 48 hours (using a 5-point Likert scale).

Conditions

Postoperative Pain; Thoracic Surgery; Video-assisted Thoracoscopic Surgery (VATS); Serratus Posterior Superior Intercostal Plane Block; Edge Laminar Block

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ELB Group

Patients undergoing VATS who received Edge Laminar Block (ELB) for postoperative pain management. ELB involves the injection of local anesthetic at the edge of the thoracic lamina as a regional anesthesia technique. The efficacy and safety of ELB will be evaluated in this group.

No interventions assigned to this group

SPSIPB Group

Patients undergoing VATS who received Serratus Posterior Superior Intercostal Plane Block (SPSIPB) for postoperative pain management. SPSIPB involves the injection of local anesthetic into the intercostal plane beneath the serratus posterior superior muscle. The efficacy and safety of SPSIPB will be evaluated in this group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Adults aged 18-75 years Scheduled for elective video-assisted thoracoscopic surgery (VATS) American Society of Anesthesiologists (ASA) physical status I-III Ability to provide informed consen

Exclusion Criteria

Known allergy or contraindication to local anesthetics Chronic opioid use or chronic pain conditions Coagulopathy or use of anticoagulant therapy Infection at the injection site Severe hepatic or renal dysfunction Pregnancy or breastfeeding Inability to understand or complete pain assessment scales

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eda Cennet Caferoğlu

Dr. Eda Cennet Caferoğlu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2025-06/84

Identifier Type: -

Identifier Source: org_study_id