Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to evaluate US-guided ESP block for postoperative analgesia management after VATS.

Detailed Description
-----------------
Postoperative pain after thoracic surgery which is attributed to muscle incision, rib retraction, and intercostal nerve damage may be severe such a degree that it may cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. Because video assisted thoracic surgery (VATS) has some advantages over open thoracotomy such as reduced pain, shoulder dysfunction, early pulmonary impairment, rapid recovery, short hospital stay and low complication risk, it has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is a less painful procedure than open thoracotomy, patients may still feel severe pain during the first hours at postoperative period. As thoracic epidural analgesia (TEA) is the gold standard analgesic technique after thoracotomy, it is also being used for analgesia management following VATS. Hence TEA has some difficulties in administration and side effects, minimally invasive analgesic techniques are supported for pain management in patients who underwent VATS. The gold standard minimal invasive analgesic technique for VATS is still be questioned. Thoracic paravertebral block (TPVB) has been evaluated as the first step regional analgesia technique after VATS. However, its administration is difficult because of its anatomical proximity to important structures such as the pleura and central neuro-axial system. Therefore it may cause complications such as pneumothorax and neuro-axial injury. The ultrasound (US) guided erector spina plane block (ESPB) - a novel interfacial plan block defined by Forero et al. in 2016 - has the advantage of being away from the pleural and neurological structures, thus the risk of complications is lower. In the literature, case reports about the analgesic effect of ESPB after thoracotomy and VATS has been increasing. However there is no randomized study for VATS yet. In this study, investigators aimed to evaluate the efficacy of US-guided ESPB for postoperative analgesia management following VATS.

Official Title
-----------------
The Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia Management Following Video Assisted Thoracic Surgery: A Prospective, Randomized Study

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Erector spinae plane block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of primary lung carcinoma Must be undergoing VATS lobectomy under general anesthesia Must be in American Society of Anesthesiologists (ASA) classification I-II status Exclusion Criteria: History of bleeding diathesis, History of receiving anticoagulant treatment, History of local anesthetics or opioid allergy, Skin infection at the site of the needle puncture, Presence of pregnancy or lactation, and Patients who did not accept the procedure

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized prospective study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block (Group I)<br>The ultrasound (US) guided ESPB was performed under aseptic conditions at the level of T5 vertebrae using the GE Vivid Q® US device. A high frequency 12 MHz linear US probe was covered with a sterile sheath and placed longitudinally 2-3 cm lateral to the T5 transvers process. After visualizing trapezius, rhomboid major, erector spinae muscles superficial to the hyperechoic transverse process shadow respectively, a 22-gauge 50 mm block needle (Braun Stimuplex Ultra 360, Germany) was inserted in a cephalad to caudad direction. Once the needle tip had been placed within the interfacial plane below the erector spinae muscle, 2 mL of saline were injected to confirm the proper injection site, and then a 20 mL dose of 0.25% bupivacaine was injected. Patients received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit | Other: Erector spinae plane block<br>* Erector spinae plane block was performed to the patients under aseptic conditions<br>|
| No Intervention: Control group (Group II)<br>Patients in control group only received fentanyl via a patient controlled analgesia (PCA) device with a protocol of 2 mL (10 µg/mL) bolus without an infusion dose, 20 min lockout time and 4 hour limit. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative opioid consumption change is being assessed | All patients received fentanyl via a patient controlled analgesia (PCA) device. | Postoperative 1, 2, 4, 8, 16 and 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain scores (Visual analoge score-VAS) is being assessed | 0 = no pain, 10 = the most severe pain felt | Postoperative 1, 2, 4, 8, 16 and 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erector spinae plane block, Video assisted thoracic surgery, Postoperative analgesia