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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06221280
• Other study ID #: 2023/10-02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Having a good mental status,

2. Those aged =18 years,

3. Term pregnant (gestational age = 36 weeks),

4. American Society of Anesthesiologists class II-III,

5. Patients who underwent cesarean section with spinal anesthesia will be included.

Exclusion Criteria:

1. Having labor at term or obstetric emergency,

2. Having a twin pregnancy,

3. Having a diagnosed psychiatric disorder/using psychiatric medication,

4. Those who are allergic to local anesthetics and/or drugs used in the study,

5. The patient-controlled anesthesia device is out of use for any reason within the first 24 hours postoperatively,

6. Having peripheral neuropathy or neuromuscular disease,

7. Patients using anticoagulant drugs that will prevent regional anesthesia will be excluded from the study.

Related Conditions & MeSH terms

• Cesarean Section
• Depression
• Depression, Postpartum
• Depressive Disorder
• Postoperative Pain
• Postpartum Depression

Intervention

Procedure:
• Nerve block
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.

Locations

Country	Name	City	State
Turkey	KahramanmarasSIU	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (VAS score)	Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section	12 months
Secondary	Postpartum depression (Edinnburg Depression Scale)	Comparison of the effectiveness of blocks for analgesia in terms of postpartum depression	12 months