M-Tapa vs OSTAP for Laparoscopic Inguinal Hernia Repair Surgery

NCT ID: NCT05476510

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-10
• Study Completion Date: 2023-07-25

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).

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Postoperative management

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Postoperative management

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Bahadir Ciftci

Primary researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul Medipol University Hospital

Istanbul, Bagcilar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30388604 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30639940 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31212124 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35468713 (View on PubMed)

Other Identifiers

Medipol Hospital 29

Identifier Type: -

Identifier Source: org_study_id