Clinical trial NCT03460093: Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section
Official title: Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Superior Hypogastric Plexus Block
Keywords: nerve blockade
hypogastric plexus
cesarean section
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: postoperative pain score
timeFrame: postoperative 1. hour
measure: postoperative pain score
timeFrame: postoperative 6. hour
measure: postoperative pain score
timeFrame: postoperative 12. hour
measure: postoperative pain score
timeFrame: postoperative 24. hour
measure: postoperative pain score
timeFrame: postoperative 48. hour
Secondary outcomes:
measure: postoperative analgesic consumption
timeFrame: postoperative 48 hours
measure: postoperative passing of gas and bowel movements
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: S.B.U Kocaeli Derince Education and Research Hospital
Study officials:
affiliation: S.B.U Kocaeli Derince Education and Research Hospital
name: bahar sarıibrahim astepe, M.D
role: PRINCIPAL_INVESTIGATOR
References: