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Completed

NCT Number: NCT06425718

Comparison of Postoperative Analgesia Methods in Elective Cesarean Section Surgeries

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Pendik Education and Research Hospital

Istanbul, 34899, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Postoperative Pain Management Technique

Procedure

Patients who will undergo cesarean section under spinal anesthesia will be included. Comparing postoperative pain and opioid consumption in groups

Primary outcomes

  1. Comparison of postoperative opioid consumption between two groups via Patient Controlled Analgesia (PCA) device

    Time frame: 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 outcomes

  1. Postoperative pain assessment with Numeric Rating Scale (NRS)

    Time frame: 24 hours

    In a Numerical Rating Scale (NRS), patients are asked to choose from 1 to 10. 1: no pain 10: worst pain experienced

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Comparison of Transversalis Fascia Plane Block and Surgical Site Local Anesthetic Infiltration in Elective Cesarean Section Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2024
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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