Comparison of Modified Perichondral Approach Thoracoabdominal Nerve Block and Transversus Abdominal Plane Block in Analgesia Management Following Caesarean Section Surgery

Cesarean Section Clinical Trial

Official title:

Comparison of Modified Perichondral Approach Thoracoabdominal Nerve Block and Transversus Abdominal Plane Block in Analgesia Management Following Caesarean Section Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06185725
• Other study ID #: Bursa City Hospital 4
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: April 2024
• Source: Bursa City Hospital
• Contact: Mursel Ekinci
• Phone: +905067137596
• Email: drmurselekinci[@]gmail.com
• 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. 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 15, 2024
• Est. primary completion date: March 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:
• Modified Perichondral Approach Thoracoabdominal Nerve Block
M-TAPA block will be performed to Group M-TAPA at the end of the surgery, using US (Vivid Q) while the patient is in the supine position After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. The US probe will be placed in the sagittal plane where the midclavicular line intersects with the costal cartilage corresponding to the costochondral angle. Using the In Plane technique, the probe is gently pushed to visualize the lower part of the costochondral angle at the central level, advancing the block needle in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage, and the block location will be confirmed. After the block location is confirmed, a total of 20 ml + 20 ml of 0.25% bupivacaine (total 40 ml for both sides) will be injected bilaterally
• Transversus Abdominal Plane Block
TAP block will be performed to Group TAP at the end of the surgery, using US (Vivid Q) while the patient is in the supine position. After providing aseptic conditions, the high frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used. USG will be placed transversely on the mid-axillary line between the iliac crest and subcostal planes. Using the In Plane technique, the block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline. The block needle will be advanced into the fascial plane between the internal oblique and transversus abdominis muscles and the location will be confirmed by administering 5 ml of saline.and than 20 ml of 0.25% bupivacaine (total 40 ml for both sides) will be injected bilaterally

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Bursa City Hospital	Ahmet Kaciroglu

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658. — 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

Roofthooft E, Joshi GP, Rawal N, Van de Velde M; PROSPECT Working Group* of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists' Association. PROSPECT guideline for elective caesarean section: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-680. doi: 10.1111/anae.15339. Epub 2020 Dec 28. — View Citation

Sutton CD, Carvalho B. Optimal Pain Management After Cesarean Delivery. Anesthesiol Clin. 2017 Mar;35(1):107-124. doi: 10.1016/j.anclin.2016.09.010. Epub 2016 Dec 12. — View Citation

Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available. — View Citation

Visser GHA, Ayres-de-Campos D, Barnea ER, de Bernis L, Di Renzo GC, Vidarte MFE, Lloyd I, Nassar AH, Nicholson W, Shah PK, Stones W, Sun L, Theron GB, Walani S. FIGO position paper: how to stop the caesarean section epidemic. Lancet. 2018 Oct 13;392(10155):1286-1287. doi: 10.1016/S0140-6736(18)32113-5. 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.	The NRS scores of the patients will be evaluated at the postoperative 0, 2, 4, 8, 16, and 24 hours.
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. (total mg dose)