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

Superior Hypogastric Plexus Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03460093
• Other study ID #: KUGOKAEK 2017/270
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Kocaeli Derince Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Superior Hypogastric Plexus Block

Locations

Country	Name	City	State
Turkey	S.B.U Kocaeli Derince Education and Research Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain score	postoperative pain score evaluated with Visual Analog Scale	postoperative 1. hour
Primary	postoperative pain score	postoperative pain score evaluated with Visual Analog Scale	postoperative 6. hour
Primary	postoperative pain score	postoperative pain score evaluated with Visual Analog Scale	postoperative 12. hour
Primary	postoperative pain score	postoperative pain score evaluated with Visual Analog Scale	postoperative 24. hour
Primary	postoperative pain score	postoperative pain score evaluated with Visual Analog Scale	postoperative 48. hour
Secondary	postoperative analgesic consumption	the amount of analgesic used (NSAIDs...) for pain relief after operation	postoperative 48 hours
Secondary	postoperative passing of gas and bowel movements	the hour of postoperative gas extraction and bowel movements	postoperative 48 hours