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COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR

Primary Purpose

Postoperative Pain, Inguinal Hernia, Transversus Abdominis Plane Block

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block
Sponsored by
Fatih Sultan Mehmet Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring inguinal hernia, Transversus abdominis plane block, postoperative pain, Total extraperitoneal hernia repair

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over the age of 18
  • Patients who underwent total extraperitoneal hernia repair
  • Patients without any postoperative complications
  • Patients who cannot be drained for any reason

Exclusion Criteria:

  • Patients who underwent another hernia repair technique during surgery for any reason.
  • Patients who do not want to participate in the study
  • Patients with any complications after surgery

Sites / Locations

  • Fatih sultan mehmet training and research hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

30 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, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography)

30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.

Outcomes

Primary Outcome Measures

Postoperative pain
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 10: too much pain , 1: no pain

Secondary Outcome Measures

patient satisfaction
Patients will be evaluated with a patient satisfaction questionnaire after surgery. 5: Very satisfied , 1:Not satisfied

Full Information

First Posted
May 1, 2021
Last Updated
May 1, 2021
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04875598
Brief Title
COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
Official Title
COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fatih Sultan Mehmet Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
While the rate of inguinal hernia repair operations in England is 10 per 100,000 people. The rate in the United States is found to be 28 per 100,000 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 0.25 % 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 (0.25 % 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 100,000 people. The rate in the United States is found to be 28 per 100,000 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 0.6 mg / kg rocuronium in patients who will undergo anesthesia induction with BIS < 60, after intubation, 40 % oxygen / 1.5 - 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 0.25 % 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, 0.5 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 0.25 % 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 (0.25 % 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 0.02 mg / kg atropine and 0.05 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia, Transversus Abdominis Plane Block
Keywords
inguinal hernia, Transversus abdominis plane block, postoperative pain, Total extraperitoneal hernia repair

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A total of 60 patients will be included in the study; Group 1: 30 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, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography) Group 2: 30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
30 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, TAPBwith 20 ml 0.25 % bupivacaine will be applied to the surgical side under ultrasonography)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
30 patients, local anesthetic injection will be made to the same area under laparoscopic direct vision. 50 mg Bupivacaine (0.25 % 20 ml bupivacaine solution) has been determined as the application dose and this amount will be applied in both groups.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block
Intervention Description
Ultrasound assisted TAPB application will be applied by an anesthesiology and reanimation specialist and Laparoscopy assisted TAPB application will be applied by the surgeon performing the operation.
Primary Outcome Measure Information:
Title
Postoperative pain
Description
10 cm visual analog scale (VAS) will be used in postoperative pain follow-up. 10: too much pain , 1: no pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
Patients will be evaluated with a patient satisfaction questionnaire after surgery. 5: Very satisfied , 1:Not satisfied
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 Patients who underwent total extraperitoneal hernia repair Patients without any postoperative complications Patients who cannot be drained for any reason Exclusion Criteria: Patients who underwent another hernia repair technique during surgery for any reason. Patients who do not want to participate in the study Patients with any complications after surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anıl Ergin
Phone
+905342245366
Email
dranilergin@gmail.com
Facility Information:
Facility Name
Fatih sultan mehmet training and research hospital
City
Istanbul
ZIP/Postal Code
34734
Country
Turkey
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anıl Ergin

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

COMPARISON OF LAPAROSCOPY AND ULTRASOUND ASSISTED TRANSVERSUS ABDOMINIS PLANE BLOCK METHODS IN LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR

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