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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Postoperative Pain; Postpartum Depression; Cesarean Section
• Intervention / Treatment: Procedure: Nerve block

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kahramanmaraş, Turkey, 46100
    • KahramanmarasSIU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group E; Patients who underwent erector spinae plane block	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.
Active Comparator: Group T; Patients who underwent transversus abdominis plane block	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain (VAS score)	Evaluation of the postoperative analgesic effectiveness of erector spinae and transversus abdominis plane blocks after cesarean section	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postpartum depression (Edinnburg Depression Scale)	Comparison of the effectiveness of blocks for analgesia in terms of postpartum depression	12 months

Collaborators and Investigators

• Sponsor: Kahramanmaras Sutcu Imam University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 4, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Nerve block, cesarean, postpartum depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: 2023/10-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No