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M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

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ClinicalTrials.gov Identifier: NCT05476510
Recruitment Status : Recruiting
First Posted : July 27, 2022
Last Update Posted : August 12, 2022
Sponsor:
Information provided by (Responsible Party):
Bahadir Ciftci, Medipol University

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).


Condition or disease Intervention/treatment Phase
Inguinal Hernia Drug: Postoperative management Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking Description: Outcomes Assessor and participant will be blinded to the stud
Primary Purpose: Treatment
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
Actual Study Start Date : August 10, 2022
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group M-TAPA = M-TAPA Block Group
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
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.

Active Comparator: Group OSTAP = OSTAP Block Group
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
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 Measures :
  1. Postoperative pain scores (Numerical Ratin Scala; 0=no pain, 10=the worst pain felt) [ Time Frame: Postoperative 24 hours period ]
    NRS at postoperative 0th hour


Secondary Outcome Measures :
  1. The use of rescue analgesia [ Time Frame: Postoperative 24 hours period ]
    Tramodol using

  2. Patient satisfaction scale (seven item likert scale; extremely dissatisfied, mostly dissatisfied, somewhat dissatisfied, neutral, somewhat satisfied, mostly satisfied, extremely satisfied) [ Time Frame: Postoperative 24 hours period ]
    This scoring system includes evaluating the satisfaction level of patient



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05476510


Contacts
Layout table for location contacts
Contact: Bahadir Ciftci, Assoc prof, MD +905343736865 bciftci@medipol.edu.tr
Contact: Selçuk Alver, Assist prof, MD 05435424234 selcukalver@yahoo.com

Locations
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Turkey
Istanbul Medipol University Hospital Recruiting
Istanbul, Bagcilar, Turkey, 34070
Contact: Bahadir Ciftci, MD    +905343736865    bciftci@medipol.edu.tr   
Sponsors and Collaborators
Medipol University
Publications:
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Responsible Party: Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier: NCT05476510    
Other Study ID Numbers: Medipol Hospital 29
First Posted: July 27, 2022    Key Record Dates
Last Update Posted: August 12, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data (IPD) will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bahadir Ciftci, Medipol University:
Laparoscopic inguinal hernia repair
Postoperative pain management
Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block
Oblique Subcostal Transversus Abdominis Plane Block
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal