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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078475
• Other study ID #: Bursa City Hospital 3
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 15, 2024

Study information

• Verified date: April 2024
• Source: Bursa City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section

Intervention

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.

Locations

Country	Name	City	State
Turkey	Mursel Ekinci	Bursa
Turkey	T.C. Saglik Bakanligi Bursa Sehir Hastanesi	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Bursa City Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global recovery scoring system (patient satisfaction scale)	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]); Able to breathe easily; Been able to enjoy food; Feeling rested; Have had a good sleep; Able to look after personal toilet and hygiene unaided; Able to communicate with; Getting support from hospital doctors and nurses; Able to return to work or usual home activities; Feeling comfortable and in control; 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]); Moderate pain; Severe pain; Nausea or vomiting; Feeling worried or anxious; 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	Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")	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.
Secondary	The use of rescue analgesia	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)