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

NCT ID: NCT03460093

Last Updated: 2019-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-15

Study Completion Date

2019-03-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Superior Hypogastric Plexus Block

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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case (SHPB+)

Superior hypogastric plexus block present

No interventions assigned to this group

control (SHPB-)

Superior hypogastric plexus block not present

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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bahar sarıibrahim astepe

obstetrics and gynecology specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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bahar sarıibrahim astepe, M.D

Role: PRINCIPAL_INVESTIGATOR

S.B.U Kocaeli Derince Education and Research Hospital

Locations

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S.B.U Kocaeli Derince Education and Research Hospital

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KUGOKAEK 2017/270

Identifier Type: -

Identifier Source: org_study_id

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