Comparison of Pain Relief Efficacy of Epidural Analgesia and Erector Spinae Plane Block Before Thoracotomy Surgery
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ClinicalTrials.gov Identifier: NCT06011863 |
Recruitment Status :
Recruiting
First Posted : August 25, 2023
Last Update Posted : October 4, 2023
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Condition or disease | Intervention/treatment |
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Thoracotomy Surgery | Procedure: Thoracic Epidural Analgesia Procedure: Erector spinae plane block |
Study Type : | Observational |
Estimated Enrollment : | 42 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Effectiveness Comparison Of Preemptive Single-Dose Thoracic Epidural Analgesia And Erector Spinae Plane Block For Thoracotomy Analgesia In Thoracic Surgery |
Actual Study Start Date : | October 3, 2023 |
Estimated Primary Completion Date : | December 27, 2023 |
Estimated Study Completion Date : | December 31, 2023 |
Group/Cohort | Intervention/treatment |
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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bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.
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Procedure: 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bupivacaine + 2 ml 0.9% saline will be administered through the epidural needle at once and the epidural needle will be withdrawn and sterile dressing will be applied.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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Procedure: Erector spinae plane block
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. |
- Visual Analogue Scale (VAS) [ Time Frame: 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 ]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."
- Inspiratory spirometry test [ Time Frame: 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 ]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).
- Postoperative nausea and/or vomiting (PONV) [ Time Frame: 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 ]Questioning about the presence/absence of nausea and/or vomiting in the postoperative period
- Amount of fentanyl used intraoperatively [ Time Frame: during surgery ]Amount of fentanyl used intraoperatively (µg)
- Amount of tramadol used postoperatively [ Time Frame: during the postoperative 24 hour ]Amount of tramadol used postoperatively (milligrams)
- Surgery duration [ Time Frame: at the end of surgery ]Time in hours from the start of the surgical incision until the last surgical suture is placed
- Anesthesia duration [ Time Frame: as soon as the patient is extubated ]time in hours from induction of anaesthesia to extubation
- Length of stay in intensive care [ Time Frame: 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 stay in intensive care unit in days
- Length of hospital stay [ Time Frame: 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 ]days of hospitalisation after the operation
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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I-III physical condition
- who were to undergo thoracotomy
Exclusion Criteria:
- patients with acute infection,
- coagulation disorder,
- morbid obesity (Body Mass Index (BMI) > 35),
- drug allergy
- history of chronic pain,
- long-term opioid use,
- history of psychiatric illness,
- emergency surgeries
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06011863
Contact: Fatma Acil | +905337225225 | acilfatma@gmail.com |
Turkey | |
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Recruiting |
Diyarbakır, Turkey, 21070 | |
Contact: Fatma Acil, M.D. +905337225225 acilfatma@gmail.com |
Principal Investigator: | Fatma Acil | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital |
Responsible Party: | Fatma Acil, Principal Investigator, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital |
ClinicalTrials.gov Identifier: | NCT06011863 |
Other Study ID Numbers: |
10.21.2022/216 |
First Posted: | August 25, 2023 Key Record Dates |
Last Update Posted: | October 4, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |