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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03460093
Recruitment Status : Completed
First Posted : March 9, 2018
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
bahar sarıibrahim astepe, Kocaeli Derince Education and Research Hospital

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

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study
Actual Study Start Date : March 15, 2018
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Groups and Cohorts
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Group/Cohort
case (SHPB+)
Superior hypogastric plexus block present
control (SHPB-)
Superior hypogastric plexus block not present


Outcome Measures
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Primary Outcome Measures :
  1. postoperative pain score [ Time Frame: postoperative 1. hour ]
    postoperative pain score evaluated with Visual Analog Scale

  2. postoperative pain score [ Time Frame: postoperative 6. hour ]
    postoperative pain score evaluated with Visual Analog Scale

  3. postoperative pain score [ Time Frame: postoperative 12. hour ]
    postoperative pain score evaluated with Visual Analog Scale

  4. postoperative pain score [ Time Frame: postoperative 24. hour ]
    postoperative pain score evaluated with Visual Analog Scale

  5. postoperative pain score [ Time Frame: postoperative 48. hour ]
    postoperative pain score evaluated with Visual Analog Scale


Secondary Outcome Measures :
  1. postoperative analgesic consumption [ Time Frame: postoperative 48 hours ]
    the amount of analgesic used (NSAIDs...) for pain relief after operation

  2. postoperative passing of gas and bowel movements [ Time Frame: postoperative 48 hours ]
    the hour of postoperative gas extraction and bowel movements


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03460093


Locations
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Turkey
S.B.U Kocaeli Derince Education and Research Hospital
Kocaeli, Turkey, 41100
Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Investigators
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Principal Investigator: bahar sarıibrahim astepe, M.D S.B.U Kocaeli Derince Education and Research Hospital
More Information
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Responsible Party: bahar sarıibrahim astepe, obstetrics and gynecology specialist, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03460093    
Other Study ID Numbers: KUGOKAEK 2017/270
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by bahar sarıibrahim astepe, Kocaeli Derince Education and Research Hospital:
nerve blockade
hypogastric plexus
cesarean section