Comparison Between Erector Spinae Plane Block And Retrolaminar Block In Patients Undergoing VATS.

Study Overview
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Brief Summary
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Post-Video-assisted thoracoscopic surgery pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post Video-assisted thoracoscopic surgery pain

Detailed Description
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Video-assisted thoracoscopic surgery (VATS) is increasingly being used to manage primary lung cancer and helps reduce postoperative pain. However, it is a fact that pain following VATS can be severe and long-lasting. According to previous study, 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery .The provision of pain relief is a significant consideration, and thoracic epidural analgesia is often regarded to be the gold standard. However, epidural analgesia is not always ideal, and other practical regional methods of analgesia after VATS have been proposed as Erector Spinae Plane Block (ESPB) or retrolaminar block (RLB) . The retrolaminar block (RLB) is a modified paravertebral block that administers local anesthetic between the lamina of the thoracic vertebra and the erector spinal muscles, using landmark technique or under ultrasound guidance. Previous clinical study reported that RLB provides a good analgesic effect after VATS but was inferior to para-vertebral block(PVB). Erector spinae plane block (ESPB) is a relatively new interfascial block procedure first described for thoracic analgesia. Previous clinical studies reported that ESPB provides a good analgesic effect after VATS (comparable with PVB) and decreases morphine consumption after Lateral thoracotomy surgery. Thus, anaesthesiologists now have a greater choice for regional anaesthesia for thoracic analgesia. Although ESPB and RLB have similar puncture sites, Only one clinical study comparing ESPB and RLB in breast surgery has been reported , The mentioned study was also limited only to female patients. both blocks were compared with PVB but There is no clinical study that compares ESPB and RLB directly in VATS. Although the mechanisms of action of both ESPB and RLB have not yet been completely clarified, one cadaveric study indicated that ESPB leads to a broader spread of the local analgesic into a more extensive range of intercostal spaces from a single point of injection than RLB . Another cadaveric study reported that the lateral pathway, which is involved in the blockade of the intercostal nerve or the lateral cutaneous branches of the intercostal nerves, is the primary mechanism of ESPB, in contrast to RLB. Based on these anatomical studies, we hypothesize that ESPB can be superior to RLB for postoperative analgesia after VATS.

Official Title
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Comparison Of The Analgesic Effect Of Ultrasound-Guided Erector Spinae Plane Block And Ultrasound-Guided Retrolaminar Block In Patients Undergoing Video Assisted Thoracoscopic Surgery: A Prospective, Randomized Study.

Conditions
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Post-operative Analgesia, Retrolaminar Block, Erector Spinae Plan Block, VATS

Intervention / Treatment
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* Procedure: Erector spinae plane block
* Procedure: Retrolaminar block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical status class (ASA) I, II and III Patients undergoing VATS. Exclusion Criteria: Patient refusal Coagulopathy, bleeding disorders, In-ability to postpone anti-coagulation medications. infection at the injection site pregnancy, breastfeeding, severe obesity (body mass index > 35 kg/m2 ) allergy to any drug used in the study preoperative daily use of a non-steroidal anti-inflammatory drug (NSAID) or opioids, Previous surgery in the thoracic vertebral region Liver dysfunction. Injury or a lesion at the block site.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Erector spinae plane block<br>will receive a US-guided ESPB | Procedure: Erector spinae plane block<br>* Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 3 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact the tip of the T4 transverse process , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. Adequacy of the block will be confirmed by ultrasonographic visualization of fluid spread (seen as a lifting of the erector spina muscles in both block) and after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.<br>|
| Active Comparator: Retrolaminar block<br>will receive a US-guided RLB | Procedure: Retrolaminar block<br>* Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 1 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact T4 lamina of the vertebra , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. And after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups | ESPB compared to RLB for postoperative analgesia after VATS | 24-hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Time is required to perform the technique in minutes. | between the start of US scanning and the local anesthetic injection | intraoperative | 
| Heart Rate | Heart rate (Bpm) at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours. | intraoperative and 24 hours postoperative | 
| Systolic arterial blood pressure | Systolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours. | intraoperative and 24 hours postoperative | 
| Diastolic arterial blood pressure | Diastolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours. | intraoperative and 24 hours postoperative | 
| Mean arterial blood pressure | Mean arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours. | intraoperative and 24 hours postoperative | 
| • Intraoperative cardioactive drug use | The number of patients requiring ephedrine and atropine | Intraoperative | 
| • Intraoperative analgesics | The number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram ) | Intraoperative | 
| • Pain score according to VAS score | VAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively. | 24 hours | 
| • First request of analgesia postoperative | The elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours | 24 hours Postoperative | 
| • Incidence of side effects related to opioid use | (postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time. | 24 hours Postoperative | 
| • Incidence of complications or side-effects related to the block | (bradycardia, hypotension, hematoma formation or intravascular injection). | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RLB, ESPB, VATS