Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Pharmaceutical Solutions

Analgesics

Antipyretics

Anti-Inflammatory Agents

Antirheumatic Agents

Anesthetics

Ropivacaine

Anesthetics, Local

Levobupivacaine

Analgesics, Opioid

Dipyrone

Pirinitramide

Patients in the experimental group will receive the erector spinae catheter prior the surgery and will be administered local anesthetics for 48 hours post-operatively.

Anesthetic regimen: initial bolus of 20ml 0.5% levobupivacaine before the end of surgery. Then continually ropivacaine 0,2% 5ml/h with intermittent boluses 15ml ropivacaine 0,2% every 4h.

Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Patients will receive standard treatment, i.e. the multi-level intercostal block administered at the end of the surgery by the surgeon. They will receive 20ml 0,5% levobupivacaine on 6 levels of the thoracic wall according to the operative wound level.

Both groups will receive multimodal analgetic treatment consisting of a patient-controlled (PCA) pump with opioid analgetics and a peripherally acting analgetic metamizol on a regular basis. The PCA pump will be set to intermittent boluses of 3mg piritramide with a lock-out time 15 min and a maximal number of 6 boluses /3 hours. Patients will receive metamizol 2,5g/12hours i.v. on the day of surgery and 500-1000mg / 6 hours orally on the first and second post-operative day.

Patients in the experimental group will receive the Erector Spinae Catheter with an initial bolus ob 20ml 0,5% levobupivacaine prior the surgery and will be administered local anesthetics for 48 hours post-operatively.

Erector Spinae Catheter

Patients in the comparative group will receive standard treatment, i.e. the multi-level intercostal block with 20ml 0,5% levobupivacaine administered at the end of the surgery by the surgeon.

Intercostal block

Patients in the experimental group will receive Ropivacaine 0,2% continous infusion of 5ml/h with boluses 15ml/4h by the Erector Spinae Catheter for 48 hours post-operatively.

Ropivacaine 0.2% Injectable Solution

Polona Gams

The purpose of the research is to prove the analgesic efficacy of a novel technique in regional anaesthesia, i.e. the catheter under the erector spinae muscle (ESC). Investigators will evaluate the use of the ESC for analgesia after video-assisted thoracoscopic lung surgeries in comparison to the standard method of post-operative analgesia, which is the multiple level intercostal block given at the end of surgery by the surgeon. Investigators will compare the amount of opioid analgesics required by the patient using the patient controlled pump, the pain status in 48-hours after surgery and compare the differences between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

The method of treatment is obvious and cannot be masked for care providers and investigators. Data will be non-labelled and therefore concealed before the outcomes assessor.

Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery

Investigators will follow up the patients in 4 and 12 weeks after surgery for possible complications. The complications will be read from the follow up documentation in observed patient files. Investigators will search for complications such as arrhythmias, lung or wound infections, lethalities or other unexpected complications.

Investigators will measure the total consumption of i.v. piritramide after surgery given by the PCA (patient-controlled analgesia) pump. The PCA pump automatically marks all the drug consumption. The PCA pump will be set to a uniform protocol: piritramide 1mg/ml; flow 0ml/h, bolus 3ml, lockout time 15 min, max 4 boluses / hour.

Investigators will compare the change between pre- and post-operative main inspiratory pressure and main expiratory pressure measurements between the two research groups.

Investigators will measure subjective perception of pain with the nubmering rating score (NRS) scoring system at resting and coughing. The NRS scoring system is a numerical scale from 0-10, with 0 being no pain and 10 the strongest pain imaginable. Patients will assess their pain with the help of analogue scale with colours and faces by each number representing different NRS pain levels.

Surgery Bitenc

Symptoms and General Pathology

Pain, Postoperative

Pain

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

Anti-Arrhythmia Agents

Channel Blockers

Vasoconstrictor Agents

Respiratory System Agents

Dexamethasone

Lidocaine

Bupivacaine

Epinephrine

Dexamethasone acetate

Racepinephrine

Epinephryl borate

BB 1101

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Adrenergic beta-Agonists

Bronchodilator Agents

Anti-Asthmatic Agents

Mydriatics

Sympathomimetics

patients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.

patients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.

ESP with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

Sham intercostal block with 20 ml Normal Saline

ESP block

Intercostal block with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

Sham ESP with 20 ml Normal Saline

Sham ESP block

Sham Intercostal block

Bupivacaine-epinephrine

Dexamethasone injection

Normal saline

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al. Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures. Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

In recent years, Video-Assisted Thoracic surgeries (VATS) has become the preferred approach for thoracic surgeries over thoracotomies, due to its clear advantages, such as improved pulmonary function, rapid recovery and reduced pain scores postoperatively. Although pain is reduced in VATS when compared to conventional thoracotomies, patients still experience moderate to severe pain, mainly due to intercostal nerve damage by ports and drains, as well as the surgical resection itself. Adequate pain relief leads to earlier and better mobilization, improves respiratory functions, and decreases global stress response. In addition, it helps in reducing the chances of developing chronic postoperative pain.

Epidural blockade has been recognized as the gold standard for analgesia in thoracic surgeries, with paravertebral blocks (PVB) replacing that standard in VATS procedures, due it's less deleterious adverse effects. Nevertheless, paravertebral blockade still poses some adverse effects such as pneumothorax and the risk of an epidural blockade. Moreover, it might prove difficult to perform in the untrained hand. Thus, a simpler blockade is warranted in patients undergoing VATS.

Proper pain relief is critical in the early postoperative period in VATS surgery, to allow early discharge of patients according to the clinical pathway milestones. The excessive consumption of opioids to achieve this goal on the other hand, may produce complications and side effects not compatible with the early discharge plan.

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al . It consists of injecting 20 ml of local anesthetic (ie.: ropivacaine 0.5%), under ultrasound guidance, at the level of the T5 transverse process in the tissue plane deep to the erector spinae muscle. A study on the ESP block was conducted on fresh human cadavers; dye mixture was injected deep to erector spinae muscle, and the spread showed to be cranio-caudal from C7 to T8, lateral spread extended to the tips of the transverse processes at all levels, penetration of the dye was beyond the costotransverse junction and anteriorly into the inter transverse spaces. In addition, there was evidence of dye penetration deep to the intercostal muscles and into the immediate vicinity of the ventral and dorsal rami of the spinal nerve roots. The authors discussed the most significant advantage of the ESP block is its simplicity and safety. The sonoanatomy is easily recognizable, there are no structures at risk of needle injury in the immediate surroundings (lower risk of nerve damage and pneumothorax), and is probably safer for patients with coagulation disorders. The technique also allows the insertion of an indwelling catheter to extend the duration of analgesia as needed.

Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures.

Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

In this randomized controlled trial, the investigator hypothesize that a single injection ESP block, would provide an effective post operative pain relief, superior to an intercostal nerve block, in patients undergoing VATS procedures.

The study will be conducted at the Montreal General Hospital, one hundred patients; ASA I-III male and female patients aged between 18 to 80 years old, who are scheduled for Video assisted thoracic surgery. Patients will be recruited before surgery. Informed consent will be obtained by a Research Assistant.

Patients will be prospectively randomized in a double blind fashion, using a computer-generated number placed in a sealed brown envelope, into either group 1, receiving ESP block, or group 2, receiving sham ESP block.

In group 1, patients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.

In group 2, patients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.

All medications will be prepared by a research assistant not assigned to the case, and not involved in the follow up assessment. Two 20 ml syringes will be prepared under sterile precautions, one containing Bupivacaine 0.25% with epinephrine 5 µg/ml and 10 mg dexamethasone, and the other containing 0.9% normal saline. Syringes will be labeled as "ESP" and "intercostal" according to the randomization. The evaluator in the postoperative period, the anesthesiologist, the patient and the surgeon will be blinded to the group randomization.

General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 2 mcg/kg, as well as rocuronium 0.6 mg/kg to facilitate tracheal intubation with a double lumen tube (DLT). A 3.2 mm fiberoptic bronchoscope will be used to confirm correct placement of the DLT, to allow one lung ventilation intraoperatively. Anesthesia will be maintained with sevofluorane or desflourane according to the anesthesiologist's preference.

For intra-operative analgesic requirements, Specific instructions will be handed to each anesthetist to administer fentanyl 25 mcg increments every 5 minutes in the following scenarios:

Elevation in the heart rate of more than 20% of baseline values. Elevation in blood pressure of more than 20% of baseline values.

Patients will receive Ondansetron 4mg prior to extubation. Post anesthetic care and medications will include.

Acetaminophen 975mg, PO or PR, Q6H Celecoxib 100mg, PO, BID for 5 days Ondansetron 4mg, PO or IV, Q8H, PRN (for nausea or vomiting) Nalbuphine 2.5 mg, IV, diluted PRN (for pruritus) Polyethylene glycol 17gr, PO, Day, PRN (for constipation)

All patients enrolled will be provided with a Patient Controlled Analgesia (PCA) pump for first 24 hours after the surgery. The pump will be programmed to deliver Morphine sulfate 1mg, lockout time 7 min, without a continuous infusion rate, capable to be increased to 1.5mg if pain VAS≥7 with the absence of sign or symptoms of toxicity. Hydromorphone will be used in case of Morphine allergy. Patients will be clearly instructed to trigger the PCA Only if they perceive pain as \>4/10 If the PCA IV line gets lost with failure to obtain a new one, in patients with VSA\>4, a rescue dose 3-5mg morphine SC Q4H PRN will be considered. The time and dose of rescue medication will be recorded.

The Standard Institutional Postoperative Clinical Pathway will be followed in both groups, except for the use of PCA.

Erector Spinae Plane Block Versus Intercostal for VATS

Ultrasound-Guided Erector Spinae Plane Block Versus Intercostal Nerve Block For Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective, Double Blind Randomized Controlled Trial

measured by total intravenous morphine consumption at 24 hours postopertively. A 25% reduction in morphine consumption would be considered statistically significant.

Pain levels will be assessed using the 10 points Numerical Rating Scale (NRS) where zero= no pain and 10= pain as bad as it can be. The NRS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels

This will be assessed using the incentive spirometer, which allows for crude measurement of inspired volumes

postoperative nausea and vomiting (PONV), hypotension, urinary retention (requiring placement of an indwelling or a temporary catheter), pruritis and oxygen requirements

total time spent in the PACU until reaching PACU discharge criteria

total time spent in the hospital until reaching hospital discharge criteria

The time it takes to perform the ESP block

Incidence of block related adverse events such as bleeding, pneumothorax and local anesthetic systemic toxicity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperative Analgesia With a Catheter Under the Erector Spinae Muscle for Videothoracoscopic Lung Surgery	NCT04665531	Neoplasm of Lun... Thoracic Surger...	Erector Spinae ... Intercostal blo... Ropivacaine 0.2...	18 Years -	Surgery Bitenc
Erector Spinae Plane Block Versus Intercostal for VATS	NCT03902782	Lung Cancer Lung Diseases	ESP block Intercostal blo... Sham ESP block Sham Intercosta... Bupivacaine-epi... Dexamethasone i... Normal saline	18 Years - 80 Years	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for intercostal block