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

NCT04875598 | Unknown

• 1 other identifier: drANILERGIN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain; Inguinal Hernia; Transversus Abdominis Plane Block

Keywords

inguinal hernia; Transversus abdominis plane block; postoperative pain; Total extraperitoneal hernia repair

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

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

  24 hours

Secondary Outcomes (1)

• patient satisfaction

  24 hours

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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)

Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block

Group 2

ACTIVE COMPARATOR

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.

Procedure: Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block

Interventions

Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block PROCEDURE

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih sultan mehmet training and research hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Hernia, Inguinal

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical

Central Study Contacts

Anıl Ergin

CONTACT

+905342245366; dranilergin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Anil Ergin

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2021
• First Posted: May 6, 2021
• Study Start: June 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 1, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

TU (1)