Postoperative PainfasciaNCT02310737
Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision
A study testing sharp incision and blunt incision in people with Postoperative Pain, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare sharp and blunt fascial entry during caesarean 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
- Postoperative Pain
- What is being tested?
- sharp incision and blunt incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- 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
Who may be able to join
- Woman having caesarean section for the first time
- Woman, who have had no previous lower abdominal surgery
- Woman who can give informed consent
Who cannot join
- Diabetes Mellitus (This does not include gestational diabetes)
- Infection
- Regular treatment with immunosuppressives
- Alcohol or drug abuse
- Age under 18 years old
- Chronic pain disease eg. fibromyalgia, rheumatoid arthritis
- BMI over 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.
Read the detailed description
The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients
- All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
- Conditions
- Postoperative Pain
- Being tested
- sharp incision, blunt incision
- Keywords
- cesarean section, facial incision, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sharp incisionProcedure or surgery
The fascia will be opened with a sharp scissors in cesarean section
blunt incisionProcedure or surgery
Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section
| Study group | Role | What they receive |
|---|---|---|
| sharp incision | Active comparator | the patients who were included as the control group (Group 1) with sharp fascia incision Receives: Procedure: sharp incision |
| blunt incision | Active comparator | the patients who were included as the another group (Group 2) with blunt fascia incision Receives: Procedure: blunt incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain scores change on the Visual Analog Scale (VAS)
the difference in pain scores between two groups 1, 3 and 7 days postoperatively. Pain is registered by a score on a vas-scale from 0-10.Changes on VAS scale reported.
Measured: 1, 3 and 7 days
Secondary outcomes (3)
postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
assessment of the sensory loss difference on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus postoperatively(day7). Sensory loss measured by asking their sensory feelings on scar area, lower abdomen, pelvic region, groin, inner thigh, and labia majus
Measured: 7 days postoperatively
postoperative pain scores change on the Visual Analog Scale (VAS)
the difference in pain scores between two groups 1 and 3 months postoperatively. Pain is registered by a score on a vas-scale from 0-10.
Measured: 1and 3 months postoperatively
postoperative sensory loss change on skin incision scar
Assessment of the sensory loss difference on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus postoperatively at 1 and 3 months. Sensory loss measured by asking their sensory feelings on scar area, lower abdomen, pelvic region, groin, inner thigh, and labia majus
Measured: 1and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma yazıcı yılmaz, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- fatma yazıcı yılmaz, md, Principal investigator, sisli etfal training research and hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02310737
- Sponsor's protocol ID
- 755
- Acronym
- fascia
- Status last verified
- Jun 2015
- First submitted
- 14 Nov 2014
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain and Neuropathy at Cesarean Sectio With Blunt or Sharp Fascia Incision: A Prospective Randomized Controlled Double-Blinded Trial
- ClinicalTrials.gov ID
- NCT02310737
- Acronym / sponsor ID
- fascia / 755
- Conditions
- Postoperative Pain
- Keywords
- cesarean section, facial incision, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Dec 2014 (estimated)
- 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.
The purpose of this study is to compare sharp and blunt fascial entry during caesarean section.
Detailed description
The patients will be divided into two group, The fascia will be opened with a sharp scissors in first group (group1), on the other hand in group 2 fascia distracted from the muscle tissue with a blunt maneuver. The study is planning to perform on women having cesarean section for the first time in their life and who have not previously had lower abdominal surgery before. The following parameters are evaluated for each patients
- All patients are evaluated for postoperative pain with VAS score when they first mobilized and following postoperative1, 3 and 7 days; 1 and 3 months 2. Postoperative sensory loss on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sharp incision | Active comparator | Procedure: sharp incisionthe patients who were included as the control group (Group 1) with sharp fascia incision |
| blunt incision | Active comparator | Procedure: blunt incisionthe patients who were included as the another group (Group 2) with blunt fascia incision |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Woman having caesarean section for the first time
- Woman, who have had no previous lower abdominal surgery
- Woman who can give informed consent
Key exclusion criteria (7 listed)
- Diabetes Mellitus (This does not include gestational diabetes)
- Infection
- Regular treatment with immunosuppressives
- Alcohol or drug abuse
- Age under 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sharp incisionThe fascia will be opened with a sharp scissors in cesarean section | Procedure or surgery | sharp incision |
| blunt incisionFascia distracted from the muscle tissue with a blunt maneuver in cesarean section | Procedure or surgery | blunt incision |
Primary outcome
postoperative pain scores change on the Visual Analog Scale (VAS)
Time frame: 1, 3 and 7 days
the difference in pain scores between two groups 1, 3 and 7 days postoperatively. Pain is registered by a score on a vas-scale from 0-10.Changes on VAS scale reported.
3 secondary outcomes
postoperative sensory loss change on skin incision scar, lower abdomen, pelvic region, groin, inner thigh, and labia majus
Time frame: 7 days postoperatively
postoperative pain scores change on the Visual Analog Scale (VAS)
Time frame: 1and 3 months postoperatively
postoperative sensory loss change on skin incision scar
Time frame: 1and 3 months postoperatively
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 9 Jun 2015.
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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.
fatma yazıcı yılmaz, md principal investigator
sisli etfal training research and hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sharp incision and blunt incision in people with Postoperative Pain, run by Sisli Hamidiye Etfal Training 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 7 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 9 Jun 2015. 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 scores change on the Visual Analog Scale (VAS) (time frame: 1, 3 and 7 days). 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 9 Jun 2015.