Comparison of Modified Perichondral Approach Thoracoabdominal Nerve Block and Transversus Abdominal Plane Block in Analgesia Management Following Caesarean Section Surgery
- Conditions
- Cesarean Section
- Interventions
- Other: Transversus Abdominal Plane BlockOther: Modified Perichondral Approach Thoracoabdominal Nerve Block
- Registration Number
- NCT06185725
- 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.
The analgesic effectiveness of TAP block has been demonstrated after cesarean section operations. m-TAPA block has been described as an alternative analgesic technique in abdominal surgeries.
The aim of this study is to compare these two analgesic methods in terms of effectiveness 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 done by cesarean section. 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.
Postoperative pain is an acute pain accompanied by the inflammatory process that occurs due to surgical trauma. 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.
Regional analgesia techniques are performed as an important part of multimodal analgesia. US-guided Transversus abdominis plane (TAP) block is one of the regional analgesia techniques that can be performed preoperatively or postoperatively. TAP block has been shown to reduce postoperative pain after hysterectomy, inguinal hernia repair, cesarean section, and colorectal 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 performed 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. In the literature, there are studies investigating the effectiveness of M-TAPA block for post-operative pain management in bariatric surgery.
The analgesic effectiveness of TAP block has been demonstrated after cesarean section operations. m-TAPA block has been described as an alternative analgesic technique in abdominal surgeries. The aim of this study is to compare these two analgesic methods in terms of effectiveness 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 & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- American Society of Anesthesiologists (ASA) classification II
- Elective cesarean section, and gestational age above 37 weeks will be included
- 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
- Arm && Interventions
Group Intervention Description Group TAP (Transversus Abdominal Plane block group) Transversus Abdominal Plane Block Patients will be performed to block at the end of the surgery. 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. Group M-TAPA (Modified Perichondral Approach Thoracoabdominal Nerve block group) Modified Perichondral Approach Thoracoabdominal Nerve Block Patients will be performed to block at the end of the surgery. 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.
- 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") The NRS scores of the patients will be evaluated at the postoperative 0, 2, 4, 8, 16, and 24 hours. 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. (total mg dose) The need for rescue analgesia will be recorded at the first 24 hours period postoperatively.
Trial Locations
- Locations (1)
T.C. Sağlık Bakanlığı Bursa Şehir Hastanesi
🇹🇷Bursa, Turkey