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

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

PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section

Study Overview

• Status: Completed
• Conditions: Superior Hypogastric Plexus Block

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41100
    • S.B.U Kocaeli Derince Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy, pregnant, literate women having cesarean-section operation with general anesthesia at H.S.U Kocaeli Derince Education and Research Hospital Obstetrics and Gynecology Clinics

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
case (SHPB+); Superior hypogastric plexus block present
control (SHPB-); 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

Collaborators and Investigators

• Sponsor: Kocaeli Derince Education and Research Hospital
• Investigators: Principal Investigator: bahar sarıibrahim astepe, M.D, S.B.U Kocaeli Derince Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: February 27, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: cesarean section; nerve blockade; hypogastric plexus
• Other Study ID Numbers: KUGOKAEK 2017/270

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No