Compared With Different Method for Postcesarean Section Analgesia

Study Overview
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Brief Summary
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The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively. Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )

Detailed Description
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This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients

Official Title
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Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Morphine hydrochloride
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women 18-50 age ASA II Fullterm singular pregnancy Exclusion Criteria: Neuraxial anesthesia is contraindicated, Allergy to the drugs to be used in the study, Refused to participate in the study, BMI>35 kg/m2 ASA≥3 Diabetes Preeclampsia, Cardiovascular disease Chronic pain and neuropathic pain, Given opioids in the operation due to intraoperative pain, Switched to general anesthesia, Excessive bleeding during the operation, Uterine atony Drain placed in the area to be infiltrated, History of drug addiction and psychiatric illness, Understand Visual analog pain scale

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI)<br>local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation | Drug: Bupivacain<br>* Group LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation<br>* Other names: fentanyl;|
| Active Comparator: Group morphine ( M )<br>intrathecal injection of morphine with local anesthesic | Drug: Morphine hydrochloride<br>* Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.<br>* Other names: fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively. | The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively. | postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively | The VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain) | 2,4,6,12,and 24 hours postoperatively |