Clinical Trials Directory

Trials / Completed

CompletedNCT03854773

Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery

Comparison Of Erector Spinae Plane Block And Thoracal Paravertebral Block For Postoperative Analgesia Management Following Vıdeo Assisted Thoracic Surgery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
Medipol University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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 (12). 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 compare US-guided ESP block and TPVB for postoperative analgesia management after VATS.

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. Thoracic epidural analgesia (TEA) which is the gold standard analgesic technique after thoracotomy, is generally used for analgesia management after VATS. However, since the surgical technique and trauma between open surgery and VATS are different, the question of what should be the gold standard for analgesia management after VATS is a topic of discussion. Especially due to the difficult administration and adverse effect profile of TEA, the opinion of minimally invasive surgical procedures, requiring less invasive analgesic techniques is supported. Thoracic paravertebral block (TPVB) has been evaluated as the first step regional analgesia technique for postoperative analgesia management after VATS. However, its administration is difficult because of its anatomical proximity to important structures such as the pleura and central neuro-axial system and it can cause complications such as pneumothorax, vascular injury. 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. The aim of this study is to compare US-guided ESP block and TPVB 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).

Conditions

Interventions

TypeNameDescription
OTHERErector spinae plane block (Group ESPB)Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
OTHERThoracal paravertebral block (Group TPVB)Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
OTHERControl group (group C)Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Timeline

Start date
2019-03-01
Primary completion
2020-05-01
Completion
2020-05-01
First posted
2019-02-26
Last updated
2020-05-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03854773. Inclusion in this directory is not an endorsement.