M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

NCT05476510 | Completed

• 1 other identifier: Medipol Hospital 29
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia repair is the most common of abdominal surgical procedures and is usually performed laparoscopically. Many factors play a role in the pain that develops after surgery and is generally considered to be visceral pain. Phrenic nerve irritation due to CO2 insufflation into the peritoneal cavity, abdominal distention, tissue trauma, sociocultural status, and individual factors are the factors that play a role in the occurrence of this pain. Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a new block that provides effective analgesia in the anterior and lateral thoracoabdominal areas, where local anesthetic is applied only to the lower side of the perichondral surface. M-TAPA block is a good alternative for analgesia of the upper dermatome levels and abdominal lateral wall and may be an opioid-sparing strategy with satisfactory quality recovery in patients undergoing laparoscopic surgery. Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) is one of the body blocks used especially for postoperative analgesia. OSTAP, defined by Hebbard in 2010, is a subcostal version of the Transversus abdominis plane block (TAP block), based on the injection of local anesthetic from the lower edge of the costal margin, obliquely between the obliquus externus and Transversus abdominis muscles. This study aimed to compare the efficacy of US-guided M-TAPA block and OSTAP block for postoperative analgesia management after laparoscopic inguinal hernia repair surgery. Our primary aim is to compare postoperative pain scores (0. hour NRS), and our secondary aim is to evaluate the use of rescue analgesics (opioids), side effects associated with opioid use (allergic reaction, nausea, vomiting), and patient satisfaction (Likert scale).

Conditions

Inguinal Hernia

Keywords

Laparoscopic inguinal hernia repair; Postoperative pain management; Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block; Oblique Subcostal Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)

  NRS at postoperative 0th hour

  Postoperative 24 hours period

Secondary Outcomes (2)

• The use of rescue analgesia

  Postoperative 24 hours period

• Patient satisfaction scale (seven item likert scale; extremely dissatisfied, mostly dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, mostly satisfied, extremely satisfied)

  Postoperative 24 hours period

Study Arms (2)

Group M-TAPA = M-TAPA Block Group

ACTIVE COMPARATOR

Under aseptic conditions, a high-frequency linear probe will be placed on the costochondral angle in the sagittal plane. Then the probe will be slightly angled deeply to visualize the lower view of the perichondrium. We will perform M-TAPA with total of 60 ml (30 ml for each side) of %0,25 bupivacaine.

Drug: Postoperative management

Group OSTAP = OSTAP Block Group

ACTIVE COMPARATOR

In the supine position, the transducer is placed in the subcostal region in an oblique plane, and a 15-20 cm needle is first inserted between the rectus abdominis and the transversus abdominis muscle and advanced towards the iliac crest in the interfascial plane. The block location will be confirmed with 5 ml of saline. After the block location is confirmed, a total of 30 ml + 30 ml of 0.25% bupivacaine (total of 60 ml for both sides) will be injected bilaterally.

Drug: Postoperative management

Interventions

Postoperative management DRUG

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by a pain nurse blinded to the procedure. 100 mg tramadol will be performed for rescue analgesia.

Group M-TAPA = M-TAPA Block Group; Group OSTAP = OSTAP Block Group

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia

You may not qualify if:

• Bleeding diathesis
• anticoagulant treatment
• local anesthetics and opioid allergy
• Infection of the skin at the site of the needle puncture
• Pregnancy or lactation
• Patients who do not accept the procedure

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

• Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.

  PMID: 30388604 BACKGROUND

• Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available.

  PMID: 30639940 BACKGROUND

• Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available.

  PMID: 31212124 BACKGROUND

• Ciftci B, Alici HA, Ansen G, Sakul BU, Tulgar S. Cadaveric investigation of the spread of the thoracoabdominal nerve block using the perichondral and modified perichondral approaches. Korean J Anesthesiol. 2022 Aug;75(4):357-359. doi: 10.4097/kja.22137. Epub 2022 Apr 26. No abstract available.

  PMID: 35468713 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal; Bites and Stings

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor and participant will be blinded to the stud
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary researcher

Model Details: Sixty patients aged 18-65 years old with American Society of Anesthesiologists (ASA) classification I-II and scheduled for laparoscopic inguinal hernia repair surgery will be included in the study. Patients will be randomly divided into two groups (Group M TAPA = M-TAPA group, Group OSTAP = OSTAP group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: August 10, 2022
• Primary Completion: July 20, 2023
• Study Completion: July 25, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)