Efficacy of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section

April 20, 2024 updated by: Mursel Ekinci, Bursa City Hospital

Efficacy Of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section Pain

Cesarean section (CS) is one of the most frequently performed surgical procedures in the World. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery.

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique 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, provides analgesia in the abdominal area at the T5-T11 level.

The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cesarean section (CS) is one of the most frequently performed surgical procedures in the World, in European countries, approximately 20% of deliveries are CS. Moderate to severe postoperative pain occurs in a significant proportion of women after cesarean surgery. This delays recovery and returning to daily life. Postoperative pain disrupts the mother-child bond, makes breastfeeding difficult, and affects the psychological state of the mother. Also inadequate postoperative analgesia may cause hyperalgesia and chronic pain.

Perioperative pain should be managed with a multi-modal approach. Opioids and nonsteroid anti inflammatory drugs should be considered as components of a multimodal analgesic regimen. However, use of both systemic and neuraxial opioids may be associated with effects (respiratory depression, nausea, vomiting, sedation, pruritus, hyperalgesia). For this, interfacial blocks may be preffered to provide postoperative analgesia and reduced opioid consumption.

Modified Perichondral Approach Thoracoabdominal Nerve (M-TAPA) block performed with ultrasound (US) is a novel technique 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, provides analgesia in the abdominal area at the T5-T11 level. Sonoanatomy is easy to visualize and the spread of local anesthetic can be easily seen under US guidance.

In the literature, there are studies investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery. However, there is no randomized study evaluating the effectiveness of M-TAPA block for postoperative analgesia management after CS. The aim of this study is to evaluate the effectiveness of US-guided M-TAPA block for postoperative analgesia management after cesarean section. The primary outcome is to compare global recovery scores, the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative rescue analgesic (opioid) use and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Recruiting
        • Mürsel Ekinci
        • Contact:
        • Sub-Investigator:
          • Ahmet Kaciroglu
      • Bursa, Turkey, 16110
        • Recruiting
        • T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
        • Contact:
        • Contact:
          • Phone Number: +90.224 975 00 00

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • American Society of Anesthesiologists (ASA) classification II
  • Elective cesarean section, and gestational age above 37 weeks will be included

Exclusion Criteria:

  • Bleeding diathesis
  • Anticoagulant treatment
  • Local anesthetics and opioid allergy
  • Infection at the site of block
  • Patients who do not accept the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group)
In group M-TAPA, M-TAPA block will be performed with patient is in the supine position. After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed in the sagittal plane where the midclavicular line intersects with the costal cartilage corresponding to the costochondral angle. Using the In Plane technique, the probe is gently pushed to visualize the lower part of the costochondral angle at the central level, advancing the block needle in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage, and the block location will be confirmed. After the block location is confirmed, a total of 20 ml + 20 ml of 0.25% bupivacaine(Buvasin %5 flakon) (total 40 ml for both sides) will be injected bilaterally.
Other: Postoperative analgesia management
Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.
Active Comparator: Group C (Control group)
In the control group, analgesics will be administered according to the protocol in postoperative analgesia management.
Other: Postoperative analgesia management
Patients will be administered paracetamol 1 gr (PERFALGAN® ) IV every 8 hours in the postoperative period.. If the patient's NRS score is ≥ 4 0,5 mg/kg IV meperidine (Aldolan ampul 100 mg/2 ml) will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global recovery scoring system (patient satisfaction scale)
Time Frame: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

We will use the Turkish version of Quality of Recovery / QoR-15 questionairre

PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent])

  1. Able to breathe easily
  2. Been able to enjoy food
  3. Feeling rested
  4. Have had a good sleep
  5. Able to look after personal toilet and hygiene unaided
  6. Able to communicate with
  7. Getting support from hospital doctors and nurses
  8. Able to return to work or usual home activities
  9. Feeling comfortable and in control

  10. Having a feeling of general well-being

    PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor])

  11. Moderate pain
  12. Severe pain
  13. Nausea or vomiting
  14. Feeling worried or anxious
  15. Feeling sad or depressed
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
Time Frame: Patients will be evaluated at the first 24 hours period postoperatively.
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
Patients will be evaluated at the first 24 hours period postoperatively.
The use of rescue analgesia
Time Frame: Meperidine consumption will be recorded at the first 24 hours period postoperatively. (Number of Participants and Concentration of Meperidin)
The need for rescue analgesia will be recorded at the first 24 hours period postoperatively.
Meperidine consumption will be recorded at the first 24 hours period postoperatively. (Number of Participants and Concentration of Meperidin)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Estimated)

May 15, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Bursa City Hospital 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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