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M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

Primary Purpose

Inguinal Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postoperative management
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Laparoscopic inguinal hernia repair, Postoperative pain management, Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block, Oblique Subcostal Transversus Abdominis Plane Block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Medipol University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group M-TAPA = M-TAPA Block Group

Group OSTAP = OSTAP Block Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)
NRS at postoperative 0th hour

Secondary Outcome Measures

The use of rescue analgesia
Tramodol using
Patient satisfaction scale (seven item likert scale; extremely dissatisfied, mostly dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, mostly satisfied, extremely satisfied)
This scoring system includes evaluating the satisfaction level of patient

Full Information

First Posted
July 25, 2022
Last Updated
July 25, 2023
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05476510
Brief Title
M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery
Official Title
Comparison of the Efficacy of US-guided M-Tapa Block vs OSTAP for Postoperative Analgesia in Patients After Laparoscopic Inguinal Hernia Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
July 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

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
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).
Detailed Description
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. Postoperative pain is acute pain accompanied by an inflammatory process due to surgical trauma and gradually decreases with tissue healing. Postoperative pain is a serious problem that reduces patient comfort and delays the patient's return to work after surgery. Successful postoperative analgesia occurs in the patient due to pain; It is a known fact that it prevents many of the effects such as being unable to breathe easily and delayed mobilization. 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 the abdominal lateral wall and may be an opioid-sparing strategy that provides a satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia in the abdominal region at the T5-T11 level. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen under US guidance. With the cephalocaudal spread of the local anesthetic solution, analgesia occurs in several dermatomes. In the literature, there are studies investigating the effectiveness of M-TAPA block for postoperative pain management in bariatric surgery. Oblique Subcostal Transversus Abdominis Plane Block (OSTAP) is one of the body blocks used especially for postoperative analgesia. OSTAP, which Hebbard defined in 2010, is a subcostal version of the Transversus abdominis plane block (TAP block) and is based on the injection of local anesthetic from the lower edge of the costal margin, obliquely between the obliquus externus and Transversus abdominis muscles. OSTAP; Although it is frequently used in laparoscopic abdominal surgery, it is a very difficult block to implement. There are studies reporting that it provides successful analgesia after various abdominal surgeries. 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), the side effects associated with opioid use (allergic reaction, nausea, vomiting), and patient satisfaction (Likert scale).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Laparoscopic inguinal hernia repair, Postoperative pain management, Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block, Oblique Subcostal Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant will be blinded to the stud
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group M-TAPA = M-TAPA Block Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group OSTAP = OSTAP Block Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Postoperative management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt)
Description
NRS at postoperative 0th hour
Time Frame
Postoperative 24 hours period
Secondary Outcome Measure Information:
Title
The use of rescue analgesia
Description
Tramodol using
Time Frame
Postoperative 24 hours period
Title
Patient satisfaction scale (seven item likert scale; extremely dissatisfied, mostly dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, mostly satisfied, extremely satisfied)
Description
This scoring system includes evaluating the satisfaction level of patient
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) classification I-II Scheduled for laparoscopic inguinal hernia repair surgery under general anesthesia Exclusion Criteria: 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
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data (IPD) will not be shared
Citations:
PubMed Identifier
30388604
Citation
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.
Results Reference
background
PubMed Identifier
30639940
Citation
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.
Results Reference
background
PubMed Identifier
31212124
Citation
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.
Results Reference
background
PubMed Identifier
35468713
Citation
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.
Results Reference
background

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M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

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