Superior Hypogastric Plexus BlockNCT03460093
Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section
An observational study of Superior Hypogastric Plexus Block, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Superior Hypogastric Plexus Block
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2018to 15 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
S.B.U Kocaeli Derince Education and Research Hospital
Kocaeli, 41100
About this study
Official title: Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study
PURPOSE: to evaluate the efficacy of superior hypogastric plexus block for pain relief after cesarean section
Read the 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.
- Conditions
- Superior Hypogastric Plexus Block
- Keywords
- nerve blockade, hypogastric plexus, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case (SHPB+) | Superior hypogastric plexus block present | |
| control (SHPB-) | Superior hypogastric plexus block not present |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
postoperative pain score evaluated with Visual Analog Scale
Measured: postoperative 1. hour
postoperative pain score
postoperative pain score evaluated with Visual Analog Scale
Measured: postoperative 6. hour
postoperative pain score
postoperative pain score evaluated with Visual Analog Scale
Measured: postoperative 12. hour
postoperative pain score
postoperative pain score evaluated with Visual Analog Scale
Measured: postoperative 24. hour
postoperative pain score
postoperative pain score evaluated with Visual Analog Scale
Measured: postoperative 48. hour
Secondary outcomes (2)
postoperative analgesic consumption
the amount of analgesic used (NSAIDs...) for pain relief after operation
Measured: postoperative 48 hours
postoperative passing of gas and bowel movements
the hour of postoperative gas extraction and bowel movements
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start15 Mar 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superior Hypogastric Plexus BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli Derince Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, bahar sarıibrahim astepe, Kocaeli Derince Education and Research Hospital
- Investigators
- bahar sarıibrahim astepe, M.D, Principal investigator, S.B.U Kocaeli Derince Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460093
- Sponsor's protocol ID
- KUGOKAEK 2017/270
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2018
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Superior Hypogastric Plexus Block For Pain Relief During Cesarean-Section: A Prospective Case-Control Study
- ClinicalTrials.gov ID
- NCT03460093
- Acronym / sponsor ID
- KUGOKAEK 2017/270
- Conditions
- Superior Hypogastric Plexus Block
- Keywords
- nerve blockade, hypogastric plexus, cesarean section
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kocaeli Derince Education and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case (SHPB+) | – | –Superior hypogastric plexus block present |
| control (SHPB-) | – | –Superior hypogastric plexus block not present |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative pain score
Time frame: postoperative 1. hour
postoperative pain score evaluated with Visual Analog Scale
postoperative pain score
Time frame: postoperative 6. hour
postoperative pain score evaluated with Visual Analog Scale
postoperative pain score
Time frame: postoperative 12. hour
postoperative pain score evaluated with Visual Analog Scale
postoperative pain score
Time frame: postoperative 24. hour
postoperative pain score evaluated with Visual Analog Scale
postoperative pain score
Time frame: postoperative 48. hour
postoperative pain score evaluated with Visual Analog Scale
2 secondary outcomes
postoperative analgesic consumption
Time frame: postoperative 48 hours
postoperative passing of gas and bowel movements
Time frame: postoperative 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bahar sarıibrahim astepe, M.D principal investigator
S.B.U Kocaeli Derince Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Superior Hypogastric Plexus Block, run by Kocaeli Derince Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain score (time frame: postoperative 1. hour). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.