The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery

NCT06684015 | Active Not Recruiting

• 1 other identifier: İ02-121-24
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Working Title The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery Study Description This study aims to evaluate the effects of intrathecal morphine added as an adjuvant to local anesthesia during spinal anesthesia and the erector spinae plane block applied at the end of cesarean surgery on postoperative serum cytokine levels, pain intensity, need for rescue analgesia, hospital anxiety and depression levels, quality of obstetric recovery, and the development of chronic postoperative pain. Study Type Study Design: Observational Model: Two parallel groups Time Perspective: Prospective Interventions Intervention Type: Drug and Block Procedure Details: In patients included in the study, intrathecal morphine is administered as an adjuvant to local anesthesia during spinal anesthesia first group. At the end of surgery, an erector spinae plane block is performed other group. Primary Outcome Measures Serum Cytokine Levels Time Frame: 0., 6. and 24. Hours Assessment Method: Serum biochemical analyses Pain Intensity and Need for Rescue Analgesia Time Frame: 2., 4., 6., 12. and 24. hours, assessed using the Numeric Rating Scale(NRS) Hospital Anxiety and Depression Levels Time Frame: Preoperative and at 24 hours postoperatively Assessment Method: Hospital Anxiety and Depression Scale (HADS) Quality of Obstetric Recovery Score Time Frame: At 24 hours postoperatively Chronic Postoperative Pain Development Time Frame: Evaluated at 4 months postoperatively Assessment Method: Short Form McGill Pain Questionnaire-2

Conditions

Cesarean Delivery; Postoperative Pain; Cytokine Levels; Chronic Pain, Postoperative

Keywords

intrathecal morphine; cesarean delivery; acute postoperative pain; spinal anesthesia; tumor necrosis factor alpha; interleukin 6; interleukin 10; Chronic pain, postoperative; erector spinae plane block

Outcome Measures

Primary Outcomes (2)

• postoperative serum cytokine

  We aimed to investigate the effects of intrathecal morphine administered as adjuvant in spiral anesthesia and erector spina plan block performed at the end of the operation on postoperative serum cytokine (Interleukin-6, Tumor Necrosis Factor-alpha, Interleukin-10) levels. In order to evaluate the basal serum cytokine levels from each patient, 5 milliliters (ml) of venous blood will be taken before the operation (after monitoring-before spinal anesthesia). In order to evaluate the changes in serum cytokine levels after the operation, the moment when the first blood sample is taken will be considered as the beginning; 5 ml of venous blood will be taken at the 6th and 24th hours. Although many time periods are stated in the literature for the control of cytokine levels (6, 11, 12), the hours planned for the control blood samples were determined as the 6th and 24th hours, considering the start and end times of the effects of the methods used in the study arms.

  24 hours

• Chronic pain

  We aimed to investigate the effects of intrathecal morphine administered as adjuvant in spiral anesthesia and erector spina plan block performed at the end of the operation on chronic pain in patients undergoing cesarean section surgery. The assessment will be made with the McGill Short Form Pain Questionnaire-2. The questionnaire consists of 22 items. Each question is evaluated with a Numeric Rating Scale. A low score is associated with less pain, while a high score is associated with more pain.

  4 months

Secondary Outcomes (4)

• postoperative acute pain

  24 hours

• amount of additional analgesic rescue

  24 hours

• Hospital anxiety and depression

  24 hours

• Obstetric Quality of Recovery

  24 hours

Study Arms (2)

Intratechal morphine

Addition of intrathecal morphine as an adjuvant to local anesthesia in routine spinal anesthesia application and multimodal analgesia applications

Drug: İNTRATECHAL MORPHİNE GROUP

Erector spinae plane block

Application of erector spinae plane block and multimodal analgesia applications at the end of the operation after routine spinal anesthesia application

Procedure: Erector Spinae Plane Block

Interventions

İNTRATECHAL MORPHİNE GROUP DRUG

Addition of intrathecal morphine as an adjuvant to local anesthesia in routine spinal anesthesia application and multimodal analgesia applications

Intratechal morphine

Erector Spinae Plane Block PROCEDURE

Application of erector spinae plane block and multimodal analgesia applications at the end of the operation after routine spinal anesthesia application

Erector spinae plane block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In our study, healthy pregnant patients who were planned to undergo elective cesarean section in Ankara University Faculty of Medicine, Department of Obstetrics and Gynecology constituted the volunteer population.

You may qualify if:

• years and older
• ASA II
• Elective surgery
• Spinal anesthesia
• To accept participation in the study and regional anesthesia applications

You may not qualify if:

• Under 18 years old
• BMI (body mass index) \>35 kilograms/meter2 (kg/m2)
• ASA III and above
• Multiple pregnancy
• Previous abdominal surgery
• History of malignancy
• Contraindication for regional anesthesia
• Known history of allergy to the drugs to be used
• Presence of chronic pain (migraine, fibromyalgia, etc.)
• History of substance abuse
• Regular use of painkillers (simple analgesics, gabapentinoids, opioids)

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

In order to evaluate the basal serum cytokine levels from each patient, 5 milliliters (ml) of venous blood will be taken before the operation (after monitoring-before spinal anesthesia). In order to evaluate the changes in serum cytokine levels after the operation, the moment when the first blood sample is taken will be considered as the beginning; 5 ml venous blood samples will be taken at the 6th and 24th hours. The collected venous blood samples will be transferred in a biochemistry tube containing separator gel in accordance with the blood product transfer protocol, and the serum samples obtained will be stored at -80 degrees after being centrifuged for 10 minutes at 3000G in the biochemistry laboratory.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Suheyla Karadag Erkoc, Associate Professor

  Ankara University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 9, 2024
• First Posted: November 12, 2024
• Study Start: March 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

TU (1)