None listed
Conditions
Brief summary
This is a prospective randomized controlled trial in adult patients undergoing thoracic surgery with CESPB. The purpose of this study is to evaluate the efficacy of postoperative analgesia using a continuous erector spinae plane block (CESPB) in comparison with continuous epidural analgesia (CEA) in patients after thoracic surgery. CESPB is mainly used in the form of a single shot, the efficacy of CESPB with leaving a catheter and the use of continuous infusion of the analgesic will be evaluated which proves a novelty of this study. The occurrence of severe pain in the postoperative period affects worsened wound healing, prolonged hospitalization, may lead to pneumonia, and create additional treatment costs. In addition, in the context of postoperative abuse of opioid drugs, it is an alternative to analgesia and leads to a reduction in the use of opioid drugs and the occurrence of related side effects. The researchers assume that the experimental CESPB procedure will significantly reduce the severity of patient pain, decrease the need for co-analgesics and opioids, and diminish the risk of side effects and postoperative complications in comparison to CEA. We believe that this study will contribute to developing a standard of perioperative analgesia in patients undergoing thoracic surgery. At the same time, CESPB is an alternative to CEA in the case of coagulation disorders or taking anticoagulants by the patient as a contraindication to the central block.
Interventions
Continuous erector spinae plane block (CESPB) procedure:
Patients will be randomly assigned to two comparison groups. The first group (experimental) will be subjected to a continuous erector spinae plane block (CESPB). The CESPB procedure will be performed on the day of surgery in the operating theatre before general anaesthesia is performed. The CESPB within the chest will be performed at the level of the transverse process of the Th4 or Th5 vertebrae. Identification and creation of space betw
Continuous erector spinae plane block (CESPB) procedure: Patients will be randomly assigned to two comparison groups. The first group (experimental) will be subjected to a continuous erector spinae plane block (CESPB). The CESPB procedure will be performed on the day of surgery in the operating theatre before general anaesthesia is performed. The CESPB within the chest will be performed at the level of the transverse process of the Th4 or Th5 vertebrae. Identification and creation of space between the erector spine muscle and transverse processes are accomplished by depositing local anaesthetic agents (LA) directly on the transverse process and observation of muscle separation from the transverse process and intercostal muscles. The whole procedure will be ultrasound-guided using the SonoLong Echo kit (PAJUNK Medical Systems, Norcross, United States). Stages of CESPB anaesthesia: 1. Skin and subcutaneous anaesthesia with 4ml 1% Lignocaine; 2. Identification of the Th4 or Th5 transverse process with a linear ultrasound transducer; 3. "In-plane" insertion of the Touhy cannula with respect to the ultrasound transducer; 4. Identification of the correct needle end position by applying a 0.9% NaCl solution; 5. Creation of space to deposit a continuous infusion catheter with approximately 5 ml 0.9% NaCl solution; 6. Catheter tunnelling, protection of the puncture site with a sterile dressing, the connection of a flow-controlled elastomer pump, and initiation of 0.2% Ropimol infusion rate of 5 mL/hr. - initiation of the infusion occurs approximately 30 mins prior to the end of the procedure and is preceded by a 10-20 ml bolus injection; - Ropimol is infused via an elastomeric pump with a predefined flow rate of 5 ml/h and calibrated for an approximate infusion time of 72 hours; - during that period the patient is strictly monitored for potential side effects, insufficient analgesia, general comfort). Importantly, during the postoperative period, coanalgesics will be used according to the standard: Paracetamol (Acetaminophen) 1.0 g IV every 6 hours, Metamizole 2.5 g IV every 12 hours, Ketoprofen 100 mg IV every 12 hours. In case of allergy or any contraindications to the above-mentioned medications, the scheme will be modified and the patient will be excluded from the study. After 48 hours, the CEA/CESPB catheter will be removed. The person performing the CESPB procedure in the experimental group will be the same anesthesiologist who performs the CEA procedure in the control group with at least 5 years of professional expertise, including a minimum of 100 CEA and 10 CESPB.
Sponsors
4th Military Hospital of Wroclaw
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients qualified for thoracic surgery 2. Age between 18-80 years old 3. The lack of blood coagulation disorders and the lack of allergy to anaesthetic agents 4. The obtained informed and written consent to participate in the study
Exclusion criteria
1. The lack of informed consent for CESPB anaesthesia 2. Technical difficulties in the placement of the CEA catheter 3. The patient's condition that makes it unable to complete the questionnaires or continue the research
Outcome results
None listed