M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery

NCT05199922 | Completed

• 1 other identifier: Medipol Hospital 24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

Laparoscopic inguinal hernia repair; Postoperative pain management; Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block

Outcome Measures

Primary Outcomes (1)

• 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).

  Change from baseline score at postoperative 24 hour

Secondary Outcomes (2)

• The use of rescue analgesia

  Postoperative 24 hours period

• Postoperative pain scores

  Postoperative 24 hours period

Study Arms (2)

Group M = M-TAPA group

ACTIVE COMPARATOR

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.

Drug: M TAPA block

Group C = Control group

NO INTERVENTION

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.

Interventions

M TAPA block DRUG

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.

Group M = M-TAPA group

Eligibility Criteria

• Age: 18 Years - 70 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
• 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

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

• 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.

  PMID: 30553219 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

• Alver S, Ciftci B, Gungor H, Golboyu BE, Ozdenkaya Y, Alici HA, Tulgar S. Efficacy of modified thoracoabdominal nerve block through perichondrial approach following laparoscopic inguinal hernia repair surgery: a randomized controlled trial. Braz J Anesthesiol. 2023 Sep-Oct;73(5):595-602. doi: 10.1016/j.bjane.2023.05.001. Epub 2023 May 16.

  PMID: 37201747 DERIVED

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 study
• 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 = M-TAPA group, Group C = Control group) including 30 patients each, before entering the operating room.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 20, 2022
• Study Start: January 19, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)