search
Back to results

Erector Spinae Plane Block or Serratus Anterior Plane (SAP) Block Following Video Assisted Thoracic Surgery

Primary Purpose

Lung Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ESP block (Group ESP)
SAP block (Group SAP)
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases focused on measuring Video assisted thoracic surgery, Postoperative pain management, Erector spina plane block, Serratus anterior plane block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for VATS under general anesthesia

Exclusion Criteria:

  • Bleeding diathesis
  • Receiving anticoagulant treatment
  • Known local anesthetics and opioid allergy
  • Infection of the skin at the site of the needle puncture
  • Pregnancy or lactation
  • Patients who do not accept the procedure

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A = ESP group

Group B = SAP group

Arm Description

ESP block (Group ESP) will be performed in the preoperative block room. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.

SAP block (Group SAP) will be performed in the preoperative block room. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.

Outcomes

Primary Outcome Measures

Opioid consumption by the patients at postoperative 24 hours period
Fentanyl using

Secondary Outcome Measures

Postoperative pain scores
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16 and 24 hours.

Full Information

First Posted
May 21, 2019
Last Updated
December 19, 2019
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT03960762
Brief Title
Erector Spinae Plane Block or Serratus Anterior Plane (SAP) Block Following Video Assisted Thoracic Surgery
Official Title
COMPARISON OF ERECTOR SPINAE PLANE BLOCK AND SERRATUS ANTERIOR PLANE BLOCK FOR POSTOPERATİVE ANALGESIA MANAGEMENT FOLLOWING VIDEO ASSISTED THORACIC SURGERY
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. US-guided serratus anterior plane (SAP) block provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study evaluating the efficacy of ESP block and SAP block following VATS in the literature.
Detailed Description
Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. The advantages of VATS procedures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. 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. The ESP block contains a local anesthetic injection into the deep fascia of erector spinae. This area is away from the pleural and neurological structures and thus minimizes the risk of complications due to injury. 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. Cadaveric studies have shown that the injection spreads to the ventral and dorsal roots of the spinal nerves and creates sensory blockade in both posterior and anterolateral thorax. In the literature, it has been reported that ESP block provides effective analgesia after open heart surgery, breast surgery and ventral hernia repair in randomized controlled studies about ESP block efficiency for postoperative analgesia management. In some case series and case reports it has been reported that ESP block provides effective analgesia after thoracotomy and VATS. Furthermore, it has been reported that it provides effective analgesia in chronic and persistant pain syndromes of thorax. US-guided serratus anterior plane (SAP) block is an interfascial plane block and was described by Blanco in 2013. A local anesthetic solution is performed into the fascial plane of serratus anterior muscle. It is easy to perform and has low complication rate because it is far away from the important neurological and vascular structures. The serratus anterior muscle may be seen easily with US guidance in the mid-axillary line. It provides effective analgesia in anterior, posterior and lateral dermatomes of thorax. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery and VATS. There is no clinical randomized study evaluating the efficacy of ESP block and SAP block following VATS in the literature. The aim of this study is to compare US-guided ESP block and SAP block for postoperative analgesia management after VATS. The primary aim is to compare perioperative and postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to blocks (pneumothorax, hematoma).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases
Keywords
Video assisted thoracic surgery, Postoperative pain management, Erector spina plane block, Serratus anterior plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Fifty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for VATS under general anesthesia will be included in the study. Patients with a history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, and patients who do not accept the procedure will be excluded from the study. Randomization will be achieved using a randomizing computer program. Patients will be randomly divided into two groups (Group A = ESP group, Group B = SAP group) including 25 patients each, before entering the operating room.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant will be blinded to the study
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A = ESP group
Arm Type
Active Comparator
Arm Description
ESP block (Group ESP) will be performed in the preoperative block room. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.
Arm Title
Group B = SAP group
Arm Type
Active Comparator
Arm Description
SAP block (Group SAP) will be performed in the preoperative block room. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.
Intervention Type
Other
Intervention Name(s)
ESP block (Group ESP)
Intervention Description
In group A, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse process. From superior to inferior, three muscles will be visualized on the hyperechoic transverse process; trapezius (upper), rhomboideus major (middle), erector spinae (lower). The block needle will be inserted cranio caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block
Intervention Type
Other
Intervention Name(s)
SAP block (Group SAP)
Intervention Description
In group B, after lateral positioning, US probe will be placed in a sagittal plane over the midclavicular region of the thoracic cage. Then the 7th rib will be identified in the midaxillary line, followed by the identification of the following muscles overlying the 6th rib: the latissimus dorsi (superficial and posterior), teres major (superior), and serratus muscle (deep and inferior). The needle will be inserted in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. 5 ml saline will be enjected for correction. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.
Primary Outcome Measure Information:
Title
Opioid consumption by the patients at postoperative 24 hours period
Description
Fentanyl using
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Postoperative pain scores
Description
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 0, 2, 4, 8, 16 and 24 hours.
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for VATS under general anesthesia Exclusion Criteria: Bleeding diathesis Receiving anticoagulant treatment Known local anesthetics and opioid allergy Infection of the skin at the site of the needle puncture Pregnancy or lactation Patients who do not accept the procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, Asist.Prof
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
29980005
Citation
Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.
Results Reference
background
PubMed Identifier
23923989
Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
Results Reference
background
PubMed Identifier
29033355
Citation
Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.
Results Reference
background

Learn more about this trial

Erector Spinae Plane Block or Serratus Anterior Plane (SAP) Block Following Video Assisted Thoracic Surgery

We'll reach out to this number within 24 hrs