The Effect of Intrathecal Morphine and Erector Spina Plan Block on Serum Cytokine Levels and Chronic Pain in Caesarean Section Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ankara University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- postoperative serum cytokine
Study Overview
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
Detailed Description
-Design of the Study The study was designed as observational, prospective, two parallel groups and single-blind. The study planned to investigate the effects of intrathecal morphine and erector spinae plane block application on serum cytokine levels and chronic pain in cesarean surgery. In order to evaluate the inflammatory response caused by surgical stress at the cytokine level and to investigate the effects of this response on acute postoperative and chronic pain, patient demographic information, medical data, biological material to be collected and volunteer surveys will be analyzed and evaluated.
Both methods to be applied are routinely used methods in cesarean surgery anesthesia applications as part of the multimodal analgesia method.
In our study, where the volunteer population of pregnant patients planned to undergo elective cesarean surgery was formed at the Gynecology and Obstetrics Clinic of Ankara University Faculty of Medicine, it is thought that the number of volunteers meeting the inclusion criteria will be reached in approximately 4 months with the evaluation of the retrospective patient population. The follow-up period of the patients included in the study was 3 months, and the total period for the study was planned as 7 months if the targeted number of patients could be reached.
Volunteers may exercise their right to withdraw from the study at any stage of the study without giving any reason. Volunteers included in the study but in cases of unsuccessful spinal anesthesia application, need for repeat spinal anesthesia application, removal of early intraoperative spinal block, application of sedation, conversion to general anesthesia, development of surgical complications (bleeding, atony, etc.), hemodynamic instability, development of need for blood product transfusion, etc. will be excluded from the study and their routine perioperative care will continue.
-Study groups Morphine group: Addition of intrathecal morphine as an adjuvant to local anesthesia in routine spinal anesthesia application and multimodal analgesia applications Erector spinae plane block group: Application of erector spinae plane block and multimodal analgesia applications at the end of the operation after routine spinal anesthesia application
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years and older
- •Elective surgery
- •Spinal anesthesia
- •To accept participation in the study and regional anesthesia applications
Exclusion Criteria
- •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)
Arms & Interventions
Intratechal morphine
Addition of intrathecal morphine as an adjuvant to local anesthesia in routine spinal anesthesia application and multimodal analgesia applications
Intervention: İNTRATECHAL MORPHİNE GROUP (Drug)
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
Intervention: Erector Spinae Plane Block (Procedure)
Outcomes
Primary Outcomes
postoperative serum cytokine
Time Frame: 24 hours
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.
Chronic pain
Time Frame: 4 months
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.
Secondary Outcomes
- postoperative acute pain(24 hours)
- amount of additional analgesic rescue(24 hours)
- Hospital anxiety and depression(24 hours)
- Obstetric Quality of Recovery(24 hours)
Investigators
Fatih Kurt
Research Assistant
Ankara University