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

Completed

• Conditions: Superior Hypogastric Plexus Block

• Registration Number: NCT03460093
• Lead Sponsor: Kocaeli Derince Education and Research Hospital

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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-09
• Study Start: 2018-03-15
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain score	postoperative 48. hour	postoperative pain score evaluated with Visual Analog Scale

Secondary Outcome Measures

Name	Time	Method
postoperative passing of gas and bowel movements	postoperative 48 hours	the hour of postoperative gas extraction and bowel movements
postoperative analgesic consumption	postoperative 48 hours	the amount of analgesic used (NSAIDs...) for pain relief after operation

Trial Locations

Locations (1)

S.B.U Kocaeli Derince Education and Research Hospital; 🇹🇷 Kocaeli, Turkey