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M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery

Primary Purpose

Hernia, Inguinal

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

About this trial

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

Eligibility Criteria

18 Years - 70 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
  • Receiving anticoagulant treatment
  • Known 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

No Intervention

Arm Label

Group M = M-TAPA group

Group C = Control group

Arm 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.

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. Wound local anesthetic infiltration will be applied to the patients in the control group. 100 mg tramadol will be performed for rescue analgesia.

Outcomes

Primary Outcome Measures

Global recovery scoring system (patient satisfaction scale)
This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions).

Secondary Outcome Measures

The use of rescue analgesia
Tramodol using
Postoperative pain scores
Change from Baseline Pain Scores at Postoperative 24 hours.

Full Information

First Posted
December 22, 2021
Last Updated
July 25, 2022
Sponsor
Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05199922
Brief Title
M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery
Official Title
Ultrasound Guided M-Tapa Block for Postoperative Analgesia Management in Patients Underwent Laparoscopic Inguinal Hernia Repair Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 19, 2022 (Actual)
Primary Completion Date
July 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (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
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which 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 with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries.
Detailed Description
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block is a novel block that provides effective analgesia of the anterior and lateral thoracoabdominal walls during laparoscopic surgery, in which 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 with satisfactory quality improvement in patients undergoing laparoscopic surgery. M-TAPA block provides analgesia at the level of T5-T11 in the abdominal region. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen. Analgesia occurs in several dermatomes thanks to the cephalocaudal spread of the local anesthetic solution. There are studies in the literature investigating the effectiveness of M-TAPA block for post-operative pain management in several abdominal surgeries. In this study, we aimed to evaluate the effectiveness of M-TAPA block for postoperative analgesia management after laparoscopic inguinal hernia repair surgery. Our primary aim is to compare the postoperative pain scores (NRS), and our secondary aim is to compare the postoperative rescue analgesic use and postoperative opioid consumption, and the side effects (allergic reaction, nausea, vomiting) associated with opioid use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
Laparoscopic inguinal hernia repair, Postoperative pain management, Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) 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 = M-TAPA group, Group C = Control group) including 30 patients each, before entering the operating room.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant will be blinded to the study
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group M = M-TAPA group
Arm Type
Active Comparator
Arm 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.
Arm Title
Group C = Control group
Arm Type
No Intervention
Arm 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. Wound local anesthetic infiltration will be applied to the patients in the control group. 100 mg tramadol will be performed for rescue analgesia.
Intervention Type
Drug
Intervention Name(s)
M TAPA block
Intervention 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 totally 40 ml (20 ml for each side) of %0,25 bupivacaine.
Primary Outcome Measure Information:
Title
Global recovery scoring system (patient satisfaction scale)
Description
This scoring system includes evaluating emotional state (12 questions), physical comfort (12 questions), psychological support (7 questions), physical independence (12 questions), and pain (7 questions).
Time Frame
Change from baseline score at postoperative 24 hour
Secondary Outcome Measure Information:
Title
The use of rescue analgesia
Description
Tramodol using
Time Frame
Postoperative 24 hours period
Title
Postoperative pain scores
Description
Change from Baseline Pain Scores at Postoperative 24 hours.
Time Frame
Postoperative 24 hours period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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 Receiving anticoagulant treatment Known 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
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PubMed Identifier
30553219
Citation
Altiparmak B, Toker MK, Uysal AI, Turan M, Demirbilek SG. Reply to Tulgar et al.: Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:150-151. doi: 10.1016/j.jclinane.2018.12.005. Epub 2018 Dec 12. No abstract available.
Results Reference
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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
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M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery

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