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

Not Applicable

Recruiting

• Conditions: Cesarean Section

• Registration Number: NCT06078475
• Lead Sponsor: Bursa City Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-07-25
• Study Start: 2023-10-01
• Study First Submitted QC: 2023-10-09
• Study First Posted: 2023-10-11
• Primary Completion: 2024-02-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-20
• Last Update Posted: 2024-04-23
• Study Completion: 2024-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global recovery scoring system (patient satisfaction scale)	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

Secondary Outcome Measures

Name	Time	Method
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")	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.
The use of rescue analgesia	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.

Trial Locations

Locations (2)

T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi; 🇹🇷 Bursa, Turkey

Mursel Ekinci; 🇹🇷 Bursa, Turkey