Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361121
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-27
Brief Title:
Mid-point Transverse Process to Pleura Block Versus Thoracic Paravertebral Block in Posterolateral Thoracotomy
Sponsor:
Fayoum University Hospital
Organization:
Fayoum University Hospital
Study Overview
Official Title:
Analgesic Efficacy of Mid-point Transverse Process to Pleura Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Posterolateral Thoracotomy Incisions A Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ultrasound guided Thoracic paravertebral TPV block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina producing ipsilateral somatosensory visceral and sympathetic nerve blockade TPV block involves the injection of local anesthetic LA into the wedge-shaped paravertebral space deep to the superior costotransverse ligament SCTL
Costach et al introduced the mid-point transverse process to pleura block MTP as a modification of conventional paravertebral block by placing the LA posterior to the SCTL under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks
In recent studies the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy video-assisted thoracic surgeries and cardiac surgeries
In our study we hypothesized that the mid-point transverse process to pleura MTP block can provide an effective analgesia comparable with thoracic paravertebral TPV block in adult patients undergoing posterolateral thoracotomy incisions
Costach et al introduced the mid-point transverse process to pleura block MTP as a modification of conventional paravertebral block by placing the LA posterior to the SCTL under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks
In recent studies the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy video-assisted thoracic surgeries and cardiac surgeries
In our study we hypothesized that the mid-point transverse process to pleura MTP block can provide an effective analgesia comparable with thoracic paravertebral TPV block in adult patients undergoing posterolateral thoracotomy incisions
Detailed Description:
After approval of the local institutional ethics committee and local institutional review board Patients who are scheduled for elective thoracic surgeries via posterolateral thoracotomy incision and fulfilling the inclusion criteria in Fayoum university hospital starting from March 2024 will be enrolled in this randomized controlled study until fulfilling sample size A detailed informed consent will be signed by the eligible participants before recruitment
The patients will be randomized into two groups MTP block group and TPV block group in a 11 ratio using a computer-generated random table The patients assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care The patients and both the surgical and anesthesia teams who are responsible for patient care and data collection are blinded from the group assignments
In this study no premedication will be given to the patients before the operation All patients will be monitored using electrocardiography pulse-oximetry capnography An arterial line will be inserted using a 20 G cannula either right or left radial artery for invasive blood pressure monitoring in the operating room
After pre-oxygenation general anesthesia will be induced with intravenous propofol 2 mgkg and fentanyl 1 μgkg After muscle relaxation with atracurium 05mgkg tracheal intubation will be performed by a cuffed endotracheal tube 7-75 size and mechanical ventilation will be applied while maintaining the end-tidal CO2 between 30 and 35 mmHg Maintenance of anesthesia will be made using inhalational anesthesia isoflurane and IV atracurium according to the patients requirements The anesthesia will be maintained with isoflurane starting at one MAC and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring BIS Complete Monitoring System PN 185-0151 Covidien IIc 15 Hampshire Street Mansfield MA 02048 USA to keep the BIS value between 40 and 60
After induction the patient will be placed in the lateral decubitus position The same anesthesiologist will perform the block
In both groups the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe HFL_50 15_6MHz Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4T5 The paraspinal muscles erector spinae trapezius rhomboid transverse processes superior costo-transverse ligament SCTL and parietal pleura will be all identified under parasagittal scanning
In MTP block group A 22G 50mm block needle SONOTAPPajunk -GeisingenGermany will be inserted in the cranial to caudal direction via an in-plane approach between the 2 transverse processes and advanced till it reaches the mid-point between the transverse process and pleura After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 025 not exceeding a maximum dose of 2 mgkg will be injected superficial to the SCTL
In the TPV block group the transverse process and the pleura will be identified and the needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 025 will be injected displacing the pleura downwards
After 15 min an incision will be made to perform the surgical procedure Continuous hemodynamic monitoring of blood pressure and heart rate will be done If the systolic blood pressure decreased to a 20 below the baseline or less than 90 mmHg 5 mg of ephedrine will be injected IV Moreover if the heart rate reduced to a 50 bpm or less 05 mg of atropine will be injected IV
At the end of the surgery isoflurane will be discontinued and the muscle relaxant will be antagonized with neostigmine 004-008 mgkg and atropine 001 mgkg and will be extubated when the patient meets the following criteria awake or arousable hemodynamically stable no ongoing active bleeding warm extremities no electrolyte abnormalities and a satisfactory arterial blood gas after the return of spontaneous respiration
After admission to the Post-Anesthesia Care Unit PACU at the end of surgery all patients will receive IV fentanyl via patient controlled analgesia PCA with concentration 10 μgml with bolus 15 μg and lockout interval 10 minutes and maximum dose of 90 μghr with no background dose for 24 hours Paracetamol 1 gm IV will be given every 8 hours The patients pain will be evaluated using a Visual Analog Scale VAS both during rest and with cough 0 no pain 10 worst pain ever at time intervals 30 minutes 1 hour 3 hours 6 hours 12 hours and 24h postoperative The total 24 h fentanyl consumption will be calculated based on the volume remaining in the PCA after 24h based on the following formula Total fentanyl consumption total volume - remaining volume x 10
The patients will be randomized into two groups MTP block group and TPV block group in a 11 ratio using a computer-generated random table The patients assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care The patients and both the surgical and anesthesia teams who are responsible for patient care and data collection are blinded from the group assignments
In this study no premedication will be given to the patients before the operation All patients will be monitored using electrocardiography pulse-oximetry capnography An arterial line will be inserted using a 20 G cannula either right or left radial artery for invasive blood pressure monitoring in the operating room
After pre-oxygenation general anesthesia will be induced with intravenous propofol 2 mgkg and fentanyl 1 μgkg After muscle relaxation with atracurium 05mgkg tracheal intubation will be performed by a cuffed endotracheal tube 7-75 size and mechanical ventilation will be applied while maintaining the end-tidal CO2 between 30 and 35 mmHg Maintenance of anesthesia will be made using inhalational anesthesia isoflurane and IV atracurium according to the patients requirements The anesthesia will be maintained with isoflurane starting at one MAC and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring BIS Complete Monitoring System PN 185-0151 Covidien IIc 15 Hampshire Street Mansfield MA 02048 USA to keep the BIS value between 40 and 60
After induction the patient will be placed in the lateral decubitus position The same anesthesiologist will perform the block
In both groups the T1-T12 thoracic spinal levels will be sonographically identified using a high frequency linear US probe HFL_50 15_6MHz Then the probe will be placed vertically and nearly 3 cm lateral to the spinous process at the thoracic level T4T5 The paraspinal muscles erector spinae trapezius rhomboid transverse processes superior costo-transverse ligament SCTL and parietal pleura will be all identified under parasagittal scanning
In MTP block group A 22G 50mm block needle SONOTAPPajunk -GeisingenGermany will be inserted in the cranial to caudal direction via an in-plane approach between the 2 transverse processes and advanced till it reaches the mid-point between the transverse process and pleura After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 025 not exceeding a maximum dose of 2 mgkg will be injected superficial to the SCTL
In the TPV block group the transverse process and the pleura will be identified and the needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 025 will be injected displacing the pleura downwards
After 15 min an incision will be made to perform the surgical procedure Continuous hemodynamic monitoring of blood pressure and heart rate will be done If the systolic blood pressure decreased to a 20 below the baseline or less than 90 mmHg 5 mg of ephedrine will be injected IV Moreover if the heart rate reduced to a 50 bpm or less 05 mg of atropine will be injected IV
At the end of the surgery isoflurane will be discontinued and the muscle relaxant will be antagonized with neostigmine 004-008 mgkg and atropine 001 mgkg and will be extubated when the patient meets the following criteria awake or arousable hemodynamically stable no ongoing active bleeding warm extremities no electrolyte abnormalities and a satisfactory arterial blood gas after the return of spontaneous respiration
After admission to the Post-Anesthesia Care Unit PACU at the end of surgery all patients will receive IV fentanyl via patient controlled analgesia PCA with concentration 10 μgml with bolus 15 μg and lockout interval 10 minutes and maximum dose of 90 μghr with no background dose for 24 hours Paracetamol 1 gm IV will be given every 8 hours The patients pain will be evaluated using a Visual Analog Scale VAS both during rest and with cough 0 no pain 10 worst pain ever at time intervals 30 minutes 1 hour 3 hours 6 hours 12 hours and 24h postoperative The total 24 h fentanyl consumption will be calculated based on the volume remaining in the PCA after 24h based on the following formula Total fentanyl consumption total volume - remaining volume x 10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None