- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05321576
Opioid-free Anesthesia With ESPB in VATS Operation
Comparison of ESPB With Opioid-free Anesthesia and Standardopioid Anesthesia in Patients Who Underwent Lobectomy With VATS Method: a Randomized Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Group 1 (opioid-free ESPB) Before induction of anesthesia, patients in this group will undergo ultrasound guidance in a sitting position on the operating table, and an erector spina plan block will be performed with bupivacaine and lidocaine, by entering unilaterally (to the side to be operated) 3 cm lateral to the T5 spinous process. Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), ketamine 2 mg/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Patients will not take any opioids throughout the surgery and will be infused with dexmedetomidine instead. Dexmedetomidine infusion will be started at a dose of 0.4 microgram/kg/hour, BIS < 50 and the dose of dexmedetomidine will be adjusted so that ANI > 50. Patients for whom dexmedetomidine could not be sufficiently effective and opioid use became mandatory will not be included in the analysis. Before postoperative awakening, patients were given 1 g i.v. paracetamol will be given.
Group 2 (standard anesthesia with opioid) Under standard monitoring (ECG, non-invasive blood pressure, and finger oxygen saturation), anesthesia induction will be performed with propofol (2 mg/kg), remifentanil 1 microgram/kg, and rocuronium 0.6 mg/kg. Bispectral index (BIS) and analgesia nociception index (ANI) monitoring will be started immediately after intubation. Patients will receive an infusion of remifentanil throughout the surgery. Remifentanil infusion will be started at a dose of 0.5 microgram/kg/hour, and the dose of remifentanil will be adjusted so that BIS < 50 and ANI > 50. Before postoperative awakening, patients were given 1 g i.v. paracetamol will be given.
Perioperative clinical and demographic data of each patient will be collected: age, gender, diagnosis, operation, ASA status, duration of surgery, duration of anesthesia. Intraoperatively, heart rate, blood pressure, ANI and BIS measurements will be made and recorded in all patients at 15-minute intervals. In addition, the total intraoperative opioid dose (Group 2) and dexmedetomidine (Group 1) dose will be recorded.
Post-awakening pain will be assessed and recorded using a visual analog scale (VAS), then patient-controlled analgesia (PCA) will be initiated, with all patients locked in 15 minutes and given 4 mg of morphine at each application by the patient. Pain assessment will be done with VAS at 6, 12, 24 and 48 hours postoperatively. In the postoperative period, the amount of morphine administered by PCA (in the first and second 24 hours) and the required additional analgesics (tramadol, paracetamol, etc.) will be recorded. Groups will be compared for primary outcome measure and secondary outcome measure.
Although neuropathic pain after VATS is less than the thoracotomy approach, it can still pose a significant postoperative problem. Pain management after VATS is especially important to prevent respiratory complications. However, intraoperative or postoperative excess morphine consumption will also negatively affect postoperative recovery after thoracic surgery. It has been shown that opioid-free anesthesia can reduce the need for morphine and reduce related complications.
In the ultrasound-guided erector spina plan block technique, which is a regional anesthesia technique that has been defined recently, local anesthetic is injected into the erector spina muscle and facial plane and spreads in the caudal and cranial directions. This technique has been successfully used as a postoperative analgesia or intraoperative regional anesthesia technique in areas such as thoracic surgery and trauma, breast surgery, abdominal surgery, and extremity surgery. Erector spina plane block or other block methods have been mostly used for postoperative analgesia after VATS, and they have been shown to provide effective postoperative analgesia and reduce morphine consumption. However, data on the use of ESPB or other block techniques for anesthesia during VATS are limited. Opioid-free anesthesia with the help of ESPB may help recovery by reducing total and postoperative morphine consumption.
The aim of this study is to compare opioid-free anesthesia with ultrasound-guided ESPB in patients who underwent lobectomy with VATS, with standard opioid-containing anesthesia in terms of postoperative morphine requirement, as well as intraoperative variables, postoperative pain management and postoperative recovery, and complications.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey, 34854
- Marmara University
-
İ̇stanbul, Maltepe, Turkey, 34854
- Marmara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- lobectomy with video-assisted thoracic surgery (VATS) method
- ASA score of 3 and below
- willing to be included
Exclusion Criteria:
- chronic pain
- current opioid use
- local anesthetic allergy
- spinal deformity or mental or psychiatric problems that prevent cooperation
- anticoagulant use
- infection at the injection site
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: erector spinae plane block group
Before this process, it will be produced from the bupivacaine plan, which will be made by entering unilaterally 3 cm lateral in the ultrasound to be made from a work section that will be made before the shipment and by lidocaine.
|
Local anesthetic injection to the erector spinae muscle plane at T5 level on the operation side.
Other Names:
|
ACTIVE_COMPARATOR: control group
give opiod in this group of patients
|
Local anesthetic injection to the erector spinae muscle plane at T5 level on the operation side.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid consumption
Time Frame: the first 48 hours after surgery
|
measurement of postoperatif opioid requirement and consumption
|
the first 48 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2022.100
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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