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Trials / Recruiting

RecruitingNCT06078475

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

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
60 (estimated)
Sponsor
Bursa City Hospital · Other Government
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPostoperative analgesia managementPatients 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.

Timeline

Start date
2023-10-01
Primary completion
2024-02-15
Completion
2024-05-15
First posted
2023-10-11
Last updated
2024-04-23

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06078475. Inclusion in this directory is not an endorsement.