Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

Marmara University

Status: Completed

Conditions: Postoperative Pain; Opioid Use

Treatments: Procedure: Postoperative Pain Management Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06425718

MarmaraClinical

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Transversalis Fascia Plane Block

Active Comparator group

Description:

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)

Treatment:

Procedure: Postoperative Pain Management Technique

Surgical Site Local Anesthetic Infiltration

Active Comparator group

Description:

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)

Treatment:

Procedure: Postoperative Pain Management Technique