Trials / Recruiting
RecruitingNCT06185725
Comparison of Modified Perichondral Approach Thoracoabdominal Nerve Block and Transversus Abdominal Plane Block in Analgesia Management Following Caesarean Section Surgery
- 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. 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
| OTHER | 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 |
Timeline
- Start date
- 2024-01-15
- Primary completion
- 2024-03-15
- Completion
- 2024-06-15
- First posted
- 2023-12-29
- Last updated
- 2024-04-23
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT06185725. Inclusion in this directory is not an endorsement.