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Enrolling by Invitation

NCT Number: NCT06221280

Effects of Nerve Blocks on Pain After Caesarean Section and Postpartum Depression

At the end of your cesarean section surgery, which is started by applying medication to the spinal cavity from your waist, pain medication will be applied between the relevant muscle and its covering from your lower abdomen or back with the help of ultrasonography and a special block needle. Then, a patient-controlled pain device with a serum containing painkillers will be connected to your vascular access, and its use and purpose will be explained to you. You will be asked about your pain condition and the severity score of your pain, if any, at certain hourly intervals. At the end of 24 hours, a pain device will be removed, your satisfaction will be questioned and your complaints, if any, will be recorded. Immediately before surgery and 4-6 days after your surgery. An evaluation survey consisting of 10 questions will be asked to you within a 5-minute period during the weeks, at a time when you are free, and your answers will be recorded.

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Key information

Conditions

Postoperative Pain Cesarean Section Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postpartum Depression Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

KahramanmarasSIU

Kahramanmaraş, 46100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Having a good mental status,
  • Those aged ≥18 years,
  • Term pregnant (gestational age ≥ 36 weeks),
  • American Society of Anesthesiologists class II-III,
  • Patients who underwent cesarean section with spinal anesthesia will be included.

Exclusion criteria

  • Having labor at term or obstetric emergency,
  • Having a twin pregnancy,
  • Having a diagnosed psychiatric disorder/using psychiatric medication,
  • Those who are allergic to local anesthetics and/or drugs used in the study,
  • The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,
  • Having peripheral neuropathy or neuromuscular disease,
  • Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

Treatment and study plan

Nerve Block

Procedure

Group E: While performing the erector spina plan block; Patients are placed in the lateral decubitus position, aseptic conditions are provided, the spinous process in the midline is determined under ultrasonography guidance, and the transverse process is determined 3 cm laterally from the T11 level. 100 mm 22G block needle erector.

Group T: The lumbar petit region will be determined and placed on the lateral abdominal wall at the mid-axillary line, between the iliac crest and the lower costal arch, via a linear probe (12-15 MHz probe). After determining the internal oblique muscle as the thickest muscle and the transversus abdominis muscle as the thinnest muscle, a 100 mm 22 G needle will be placed in the same plane as the USG probe (in-plane or long axis technique). The progress of the needle will be observed on ultrasound along with the facial click sensation. After the second click sensation is felt between the internal oblique and transversalis fascia.

Primary outcomes

  1. Pain (VAS score)

    Time frame: 12 months

    Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section

Secondary outcomes

  1. Postpartum depression (Edinnburg Depression Scale)

    Time frame: 12 months

    Comparison of the effectiveness of blocks for analgesia in terms of postpartum depression

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Official study title

Effects of Transversus Abdominis and Erector Spina Plane Blocks on Post-Cesarean Pain Control and Postpartum Depression

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 24, 2024
Registry last updated
Sep 19, 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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