Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

Not Applicable

Completed

• Conditions: Postoperative Pain; Opioid Use
• Interventions: Procedure: Postoperative Pain Management Technique

• Registration Number: NCT06425718
• Lead Sponsor: Marmara University

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.

Study Timeline

• Study First Submitted: 2024-04-26
• Study Start: 2024-05-15
• Study First Submitted QC: 2024-05-21
• Study First Posted: 2024-05-22
• Primary Completion: 2024-06-26
• Study Completion: 2024-06-26
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical Site Local Anesthetic Infiltration	Postoperative Pain Management Technique	Local anesthetic infiltration will be applied to the surgical incision area with 0.25% 20 ml bupivacaine and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 10 minutes)
Transversalis Fascia Plane Block	Postoperative Pain Management Technique	Bilateral Transversalis Fascia Plane Block (with %0.25 bupivacaine, 20 ml for each side) and intravenous tramadol via Patient Controlled Analgesia device (5 mg/ml tramadol, bolus dose: 1ml, lock time: 10 minutes)

Primary Outcome Measures

Name	Time	Method
Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device	24 hours	Intravenous patient-controlled analgesia (PCA) is a system of opioid delivery that consists of an infusion pump interfaced with a timing device. Intravenous tramadol consumption will be recorded via PCA device, then it will be documented in mg/kg units.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain assessment with Numeric Rating Scale (NRS)	24 hours	In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced

Trial Locations

Locations (1)

Marmara University Pendik Education and Research Hospital; 🇹🇷 Istanbul, Turkey