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Completed

NCT Number: NCT03460093

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

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

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

S.B.U Kocaeli Derince Education and Research Hospital

Kocaeli, 41100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kocaeli Derince Education and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2018
Registry last updated
Mar 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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