M-Tapa Block for Laparoscopic Inguinal Hernia Repair Surgery

Sponsor
Medipol University (Other)
Overall Status
Completed
CT.gov ID
NCT05199922
Collaborator
(none)
60
1
2
6
10

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: M TAPA block
N/A

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.

Study Design

Study Type:
Interventional
Actual 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 = M-TAPA group, Group C = Control group) including 30 patients each, before entering the operating room.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:
Double (Participant, Outcomes Assessor)
Masking Description:
Outcomes Assessor and participant will be blinded to the study
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided M-Tapa Block for Postoperative Analgesia Management in Patients Underwent Laparoscopic Inguinal Hernia Repair Surgery
Actual Study Start Date :
Jan 19, 2022
Actual Primary Completion Date :
Jul 20, 2022
Actual Study Completion Date :
Jul 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group M = M-TAPA group

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
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.

No Intervention: Group C = Control group

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.

Outcome Measures

Primary Outcome Measures

  1. Global recovery scoring system (patient satisfaction scale) [Change from baseline score at postoperative 24 hour]

    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

  1. The use of rescue analgesia [Postoperative 24 hours period]

    Tramodol using

  2. Postoperative pain scores [Postoperative 24 hours period]

    Change from Baseline Pain Scores at Postoperative 24 hours.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medipol University Hospital Istanbul Bagcilar Turkey 34070

Sponsors and Collaborators

  • Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bahadir Ciftci, Primary researcher, Medipol University
ClinicalTrials.gov Identifier:
NCT05199922
Other Study ID Numbers:
  • Medipol Hospital 24
First Posted:
Jan 20, 2022
Last Update Posted:
Jul 26, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 26, 2022