Clinical trial NCT06425718: Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries
Official title: Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use
Postoperative Pain
Keywords: opioid use
postoperative pain
transversalis plane block
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2024-05-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, multimodal analgesia strategies with peripheral nerve blocks are preffered with greater safety in elective Cesarean section surgeries.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis fascia plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

Detailed description: After Cesarean sections, several factors play a role in the formation of postoperative pain, including parietal stimulation originating from the surgical incision, visceral stimulation originating from the peritoneum, and manipulation of intra-abdominal structures.

To enhance patients' rehabilitation during the postoperative period, promote lactation and infant care, and reduce hospital stays, the most appropriate postoperative analgesia method should be selected.

Since many intravenous anesthetic agents administered to the mother can cross the placental barrier and cause fetal side effects, regional anesthesia techniques are preferred with greater safety in elective Cesarean section surgeries.

In the postoperative period, multimodal analgesia strategies can be used for pain control, and one of these strategies is postoperative peripheral nerve blocks. Ultrasound guided transversalis fascia plane block is one of the preferred methods for postoperative analgesia in cesarean section patients.

The primary objective of this study is to compare postoperative opioid consumption and pain scores (NRS) in elective cesarean section patients who receive a transversalis plane block versus those who receive surgical site local anesthetic infiltration in addition to spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* ASA II-III patients undergoing elective cesarean section

Exclusion Criteria:

* ASA IV patients
* Patients with known neurologic or psychiatric disorders
* Patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
* Patients with alcohol or drug addiction
* Mentally disabled patients
* Patients with BMI\>30
* Patients who develop massive bleeding or coagulopathy

Primary outcomes:
measure: Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative pain assessment with Numeric Rating Scale (NRS)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Pendik Education and Research Hospital
Study officials:
affiliation: Marmara University
name: Beliz Bilgili
role: PRINCIPAL_INVESTIGATOR
References: