Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section

Study Overview
=================
Brief Summary
-----------------
PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

Detailed Description
-----------------
Superior hypogastric plexus block(SHPB) for pain relief is routinely implemented in cesarean section operations at H.S.U Kocaeli Derince Education and Research Hospital. The implementation of this procedure depends on the clinical situation of the patient, the preference of the surgeon and the anesthesiologist, the course of the operation, and whether the patient wishes or not. Superior hypogastric plexus block is performed with 0.25 % bupivacaine 30 ml injected under peritoneum above promontorium. This is a prospective case-control study. The sample consisted of 60 women having cesarean-section with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital divided into two groups: the first group having superior hypogastric plexus block for pain relief and the control group not having superior hypogastric plexus block. All participants signed an informed consent and the study was approved by the Ethics Committee of Kocaeli University ( KUGOKAEK 2017/270). The sample size was calculated with G Power 3.1 program. With ki-square Goodness-of-fit test α:0.05 ,power 95% ,effect size 0.5 total sample size was calculated 52, including 26 in case group and 26 in control group. Women having cesarean-section with spinal anesthesia, women with known bupivacaine allergy, women with anxiety-depression disorder, women with known fibromyalgia were not enrolled to the study. Age, BMI(body mass index), education status, VAS (visual analog scale) scores ,the amount of analgesic used and the hour of gas extraction and bowel movement will be recorded.

Official Title
-----------------
Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study

Conditions
-----------------
Superior Hypogastric Plexus Block

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women having cesarean-section operation at H.S.U Kocaeli Derince Education and Research Hospital with general anesthesia, Women agree to participate in the study, Literate women. Exclusion Criteria: Women having cesarean-section with spinal anesthesia, Women with known bupivacaine and NSAIDS allergy, Women with anxiety-depression disorder, Women with known fibromyalgia. Insufficient ability to understand information in Turkish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case (SHPB+)<br>Superior hypogastric plexus block present | |
| control (SHPB-)<br>Superior hypogastric plexus block not present | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | postoperative pain score evaluated with Visual Analog Scale | postoperative 1. hour | 
| postoperative pain score | postoperative pain score evaluated with Visual Analog Scale | postoperative 6. hour | 
| postoperative pain score | postoperative pain score evaluated with Visual Analog Scale | postoperative 12. hour | 
| postoperative pain score | postoperative pain score evaluated with Visual Analog Scale | postoperative 24. hour | 
| postoperative pain score | postoperative pain score evaluated with Visual Analog Scale | postoperative 48. hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative analgesic consumption | the amount of analgesic used (NSAIDs...) for pain relief after operation | postoperative 48 hours | 
| postoperative passing of gas and bowel movements | the hour of postoperative gas extraction and bowel movements | postoperative 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve blockade, hypogastric plexus, cesarean section