Clinical trial NCT06078475: Efficacy of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section
Official title: Efficacy Of Modified Perichondral Approach Thoracoabdominal Nerve Block For Post Cesarean Section Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean Section Pain
Postoperative Analgesia
Modified Perichondral Approach Thoracoabdominal Nerve Block
Lead sponsor: Bursa City Hospital
Sponsor class: OTHER_GOV
First posted: 2023-10-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two models for this study. Modified Perichondral Approach Thoracoabdominal Nerve block (M-TAPA block) group, and Control (C) group
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Global recovery scoring system (patient satisfaction scale)
timeFrame: 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 outcomes:
measure: Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
timeFrame: Patients will be evaluated at the first 24 hours period postoperatively.
measure: The use of rescue analgesia
timeFrame: Meperidine consumption will be recorded at the first 24 hours period postoperatively. (Number of Participants and Concentration of Meperidin)
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
city: Bursa
country: Turkey
facility: Mursel Ekinci
Study officials:
References:
citation: Riemma G, Schiattarella A, Cianci S, La Verde M, Morlando M, Sisti G, Esposito I, Della Corte L, Sansone P, De Franciscis P. Transversus abdominis plane block versus wound infiltration for post-cesarean section analgesia: A systematic review and meta-analysis of randomized controlled trials. Int J Gynaecol Obstet. 2021 Jun;153(3):383-392. doi: 10.1002/ijgo.13563. Epub 2021 Feb 11.
citation: Kintu A, Abdulla S, Lubikire A, Nabukenya MT, Igaga E, Bulamba F, Semakula D, Olufolabi AJ. Postoperative pain after cesarean section: assessment and management in a tertiary hospital in a low-income country. BMC Health Serv Res. 2019 Jan 25;19(1):68. doi: 10.1186/s12913-019-3911-x.
citation: Kara U, Simsek F, Kamburoglu H, Ozhan MO, Alakus U, Ince ME, Eksert S, Ozkan G, Eskin MB, Senkal S. Linguistic validation of a widely used recovery score: quality of recovery-15 (QoR-15). Turk J Med Sci. 2022 Apr;52(2):427-435. doi: 10.55730/1300-0144.5330. Epub 2022 Apr 14.
citation: Ohgoshi Y, Ando A, Kawamata N, Kubo EN. Continuous modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) for major abdominal surgery. J Clin Anesth. 2020 Mar;60:45-46. doi: 10.1016/j.jclinane.2019.08.031. Epub 2019 Aug 20. No abstract available.
citation: 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.