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In patients who will undergo open thoracic surgery, two different types of drugs will be administered to volunteer patients before surgery in order to relieve postoperative pain, facilitate breathing and reduce hospitalization time. The pain intensity, respiratory capacity, the amount of opioid analgesic needed during and after surgery, side effects such as nausea-vomiting, low blood pressure and shortness of breath will be evaluated.
Group Thoracic Epidural Analgesia (TEA): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
The intervention will be administered only once, 3-4 mg of morphine hydrochloride + 5 ml of 0.5 % bupivacaine + 2 ml of 0.9 % saline into the epidural space.
Grup Erector spinae plane block (ESP): Before induction of anaesthesia, the patient will be placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions will be fulfilled.
The linear ultrasonogram (USG) probe will first be placed in the sagittal plane to visualise the vertebral spinous process. Then the linear probe was moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated on, and the probe will be rotated 90 degrees to the longitudinal plane to visualise the transverse process. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge, 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then, 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group TEA (Thoracic Epidural Analgesia) | Group TEA (Thoracic Epidural Analgesia): Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied. |
| |
| Grup ESP ( Erector spinae plane block) | Group ESP: Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge , 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Epidural Analgesia | Procedure | Thoracic Epidural Application: The epidural area will be accessed from the 7th (T7)-8th (T8) level of the thoracic vertebral midline with an 18 gauge (G) epidural needle using the hanging drip technique. After 2 ml of 2% lidocaine is administered and no spinal effect is observed, a mixture of morphine and local anaesthetic 3-4 mg morphine hydrochloride + 5 ml 0.5% bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." | At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Inspiratory spirometry test | The inspiratory spirometry test will be performed and the inspiratory flow rate calculated according to the number of rising balls will be recorded (1 ball = 600 ml, 2 balls = 900 ml, 3 balls = 1200 ml). | At the minute of admission to the postoperative care unit (PACU),in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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patients undergoing thoracotomy surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Acil | Contact | +905337225225 | acilfatma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Fatma Acil | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Recruiting | Diyarbakır | 21070 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35251398 | Background | Zhang Y, Fu Z, Fang T, Wang K, Liu Z, Li H, Jiang W, Cao X. A comparison of the analgesic efficacy of serratus anterior plane block vs. paravertebral nerve block for video-assisted thoracic surgery: a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):134-142. doi: 10.5114/wiitm.2021.105725. Epub 2021 Apr 30. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 9, 2024 | |
| Reset | Jun 21, 2024 |
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| Erector spinae plane block | Procedure | Before induction of anaesthesia, the patient is placed on the operating table and placed in a forward tilted position. Asepsis and antisepsis conditions are provided. The linear USG probe is moved approximately 2-3 cm lateral to the spinous process T5 - T6 level on the side to be operated. The trapezius, rhomboid major and erector spinae muscles will be identified to find the correct probe position. A 22 gauge 50 mm or 22 gauge 80 mm single shot nerve blocks needle will be inserted through the skin in a cranio-caudal direction. With the needle resting on the transverse process, the plane between the erector spinae muscle and the transverse process will be verified by hydrodissection with 5 ml saline solution. Then 20 ml of 0.25% bupivacaine will be injected. The ESP block will be considered successful if the local anaesthetic spreads linearly up to the T8 - T9 level. The patient will then be placed in the supine position and general anaesthesia will be administered. |
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| Postoperative nausea and/or vomiting (PONV) | Questioning about the presence/absence of nausea and/or vomiting in the postoperative period | At the minute of admission to the postoperative care unit (PACU), in the first 30 minutes after surgery, in the 2nd hour after surgery, in the 6th hour after surgery, in the 12th hour after surgery, at the 24th hour after surgery |
| Amount of fentanyl used intraoperatively | Amount of fentanyl used intraoperatively (µg) | during surgery |
| Amount of tramadol used postoperatively | Amount of tramadol used postoperatively (milligrams) | during the postoperative 24 hour |
| Surgery duration | Time in hours from the start of the surgical incision until the last surgical suture is placed | at the end of surgery |
| Anesthesia duration | time in hours from induction of anaesthesia to extubation | as soon as the patient is extubated |
| Length of stay in intensive care | Length of stay in intensive care unit in days | It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first |
| Length of hospital stay | days of hospitalisation after the operation | It is assessed for up to 12 months from the date of surgery to the date of the first documented progression or the date of death from any cause, whichever comes first |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 9, 2024 | Jun 21, 2024 |
| ID | Term |
|---|---|
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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