Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875598
Status:
UNKNOWN
Last Update Posted:
2021-05-06
First Post:
2021-05-01
Brief Title:
COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
Sponsor:
Fatih Sultan Mehmet Training and Research Hospital
Organization:
Fatih Sultan Mehmet Training and Research Hospital
Study Overview
Official Title:
COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
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:
While the rate of inguinal hernia repair operations in England is 10 per 100000 people The rate in the United States is found to be 28 per 100000 people Today the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated Laparoscopic approach offers many advantages over open repair Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain In this sense the Transversus Abdominis Plane Block TAPB emerges as an effective regional anesthesia method that reduces postoperative pain This method can be applied with the help of ultrasound or laparoscopy The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair TEP to reveal the effects of postoperative pain
A total of 60 patients will be included in the study 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area Before the operation starts TAPB with 20 ml 025 bupivacaine will be applied to the surgical side under ultrasonography In the other 30 patients local anesthetic injection will be made to the same area under laparoscopic direct vision 50 mg Bupivacaine 025 20 ml bupivacaine solution has been determined as the application dose and this amount will be applied in both groups
10 cm visual analog scale VAS will be used in postoperative pain follow-up 50 mg intravenous tramadol will be administered to patients with VAS 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
A total of 60 patients will be included in the study 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area Before the operation starts TAPB with 20 ml 025 bupivacaine will be applied to the surgical side under ultrasonography In the other 30 patients local anesthetic injection will be made to the same area under laparoscopic direct vision 50 mg Bupivacaine 025 20 ml bupivacaine solution has been determined as the application dose and this amount will be applied in both groups
10 cm visual analog scale VAS will be used in postoperative pain follow-up 50 mg intravenous tramadol will be administered to patients with VAS 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
Detailed Description:
While the rate of inguinal hernia repair operations in England is 10 per 100000 people The rate in the United States is found to be 28 per 100000 people Today the effectiveness between open repair and laparoscopic repair in inguinal hernia repair is still debated Laparoscopic approach offers many advantages over open repair These are topics such as postoperative pain quick recovery and shortening of returning to work Postoperative pain is the most important determinant of recovery after abdominal surgeries Postoperative pain can be explained by two pathways connected to the peritoneum The first is the parietal peritoneum which has a very rich innervation and the other is the visceral peritoneum stimulated by the vagus In order to eliminate these peritoneal pains surgeons have been injecting local anesthetic into various areas on the anterior abdominal wall and intraperitoneal space since 1950 Regional blocks have an important place in the multi-modal anesthesia approach applied to reduce postoperative pain In this sense the Transversus Abdominis Plane Block TAPB emerges as an effective regional anesthesia method that reduces postoperative pain TAPB It is a type of regional anesthesia applied to the facial plane between the internal oblique muscle and the transversus abdominis muscles targeting the somatic nerves T6 - L1 This method can be applied with the help of ultrasound or laparoscopy The aim of this study is to compare the ultrasound-assisted TAPB application and Laparoscopy-assisted TAPB application in Total Extraperitoneal hernia repair TEP to reveal the effects of postoperative pain
TEP will be performed with 2-3 mg kg propofol 2 mcg kg fentanyl and 06 mg kg rocuronium in patients who will undergo anesthesia induction with BIS 60 after intubation 40 oxygen 15 - 2 sevoflurane inhalation will be applied to keep the BIS value between 40 - 60 in 60 air Before the operation starts TAPB will be made with 20 ml 025 bupivacaine in the direction of ultrasonography on the side to be operated During the operation if there is a 20 increase in blood pressure and heart rate from baseline 05 mcg kg intravenous fentanyl will be administered and the administered fentanyl dose will be recorded 1gr paracetamol 30 minutes before the end of the operation and 4 mg ondansetron 15 minutes before the end of the operation will be administered intravenously With the help of a 22 G injector local anesthetic injection will be made from the anterior to the area where the midaxillary line intersects the Bogros area Digital examination will be performed to define the injection site and the injection area will be determined
A total of 60 patients will be included in the study 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area Before the operation starts TAPB with 20 ml 025 bupivacaine will be applied to the surgical side under ultrasonography In the other 30 patients local anesthetic injection will be made to the same area under laparoscopic direct vision 50 mg Bupivacaine 025 20 ml bupivacaine solution has been determined as the application dose and this amount will be applied in both groups Bart 3D anatomical polypropylene patch will be used in both groups and the patch will be attached with the help of 1 absorbable tacker Carbon dioxide gas will be given to the preperitoneal area at a rate of 4 - 6 L min and at a pressure of 15 mm Hg 3 trocars will be used One 10 mm camera trocar and two 5 mm working trocars will be entered through the midline below the navel At the end of the operation the patients will be extubated by antagonizing the muscle relaxant effect with 002 mg kg atropine and 005 mg kg neostigmine 10 cm visual analog scale VAS will be used in postoperative pain follow-up 50 mg intravenous tramadol will be administered to patients with VAS 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
TEP will be performed with 2-3 mg kg propofol 2 mcg kg fentanyl and 06 mg kg rocuronium in patients who will undergo anesthesia induction with BIS 60 after intubation 40 oxygen 15 - 2 sevoflurane inhalation will be applied to keep the BIS value between 40 - 60 in 60 air Before the operation starts TAPB will be made with 20 ml 025 bupivacaine in the direction of ultrasonography on the side to be operated During the operation if there is a 20 increase in blood pressure and heart rate from baseline 05 mcg kg intravenous fentanyl will be administered and the administered fentanyl dose will be recorded 1gr paracetamol 30 minutes before the end of the operation and 4 mg ondansetron 15 minutes before the end of the operation will be administered intravenously With the help of a 22 G injector local anesthetic injection will be made from the anterior to the area where the midaxillary line intersects the Bogros area Digital examination will be performed to define the injection site and the injection area will be determined
A total of 60 patients will be included in the study 30 of these patients will be injected with local anesthetic into the fascia between the transversus abdominis and internal oblique muscles with the help of ultrasound from the designated area Before the operation starts TAPB with 20 ml 025 bupivacaine will be applied to the surgical side under ultrasonography In the other 30 patients local anesthetic injection will be made to the same area under laparoscopic direct vision 50 mg Bupivacaine 025 20 ml bupivacaine solution has been determined as the application dose and this amount will be applied in both groups Bart 3D anatomical polypropylene patch will be used in both groups and the patch will be attached with the help of 1 absorbable tacker Carbon dioxide gas will be given to the preperitoneal area at a rate of 4 - 6 L min and at a pressure of 15 mm Hg 3 trocars will be used One 10 mm camera trocar and two 5 mm working trocars will be entered through the midline below the navel At the end of the operation the patients will be extubated by antagonizing the muscle relaxant effect with 002 mg kg atropine and 005 mg kg neostigmine 10 cm visual analog scale VAS will be used in postoperative pain follow-up 50 mg intravenous tramadol will be administered to patients with VAS 4 and tramadol will be supplemented to 100 mg in patients with high pain levels after 30 minutes Oral non-steroidal anti-inflammatory will be given at the postoperative 8th hour Patients whose pain persists despite current therapy will be given 25 mg of meperidine intravenously as a rescue analgesic The doses of analgesic administered in the postoperative period and the hours of administration will be recorded
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