PregnancyNCT02257255
Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment
A study testing Pfannenstiel cesarean section and Misgav-Ladach cesarean section in people with Pregnancy, run by Universidade do Vale do Sapucai at 1 site in Brazil.
Trial summary
Cesarean section is the most performed abdominal surgery in women, worldwide. The World Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery. However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in hospitals and private clinics. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Pfannenstiel cesarean section and Misgav-Ladach cesarean section
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primiparous patients who are undergoing cesarean section
Who cannot join
- Previous pelvic and/or abdominal surgery ;
- Emergency cesarean section, due to placenta previa, fetal distress, cord prolapse or other obstetric emergencies;
- Pregnancies below 36 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Cesarean section is the most performed abdominal surgery in women, worldwide. The World Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery. However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in hospitals and private clinics.
The most used technique of cesarean section is the known as Pfannenstiel or Classical technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive technique.
Read more
Several studies have show that the minimally invasive technique is faster and promotes lower costs and less intraoperative bleeding. There is no current evidence that this technique is less painful.
This study aims to compare the postoperative pain in both techniques,by means of two pain scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the McGill Scale.
Read the detailed description
- STUDY Primary, clinical, prospective, randomized, double blind with, controlled, two parallel groups interventional and analytical.
- MATERIAL
A-CALCULATION OF SAMPLE SIZE
Were used to calculate the size of the sample study data Antalon et al. (2001), who also compared the two techniques of caesarean section, and the Student's t-test was used bi flow. Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and significant a difference of two points, the calculated number of patients per group was 15, with a significance level of 5% and power of 95 test %.
C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION
The allocation will be determined by random sequence generated by computer (BioStat 5.0 software, Mamiraua Institute, Brazil). The sequence had been held by the researcher who will make allocation of patients to groups in caesarean Pfannenstiel or Misgav-Ladach, 15 in each group.
D-PROCEDURES
ANESTHESIA:
In both groups will be performed spinal anesthesia at L2-L4 with heavy bupivacaine 13 mg and morphine 0.1 mg% standardized by the Anesthesiology Service of HCSL.
SURGICAL PROCEDURE:
Surgical procedure (classical technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
- Traditional Preparation: pubic shaving, prior bladder emptying.
- Asepsis with degerminate clorhexidine and alcoholic
- The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.
- Cross Opening subcutaneous tissue.
- Opening Aponeurosis transversely, hemostasis of bleeding vessels.
- Separation by dissection of the anterior rectus sheath muscles of the abdomen to the umbilicus.
- Separation of the muscles of the median raphe manually, exposure, clamping and opening the parietal peritoneum with scissors longitudinally.
- Opening of the visceral peritoneum transversely with scissors, taking off the bladder from the uterus.
- Hysterotomy segment transverse, arcuate, superior concavity, made a small incision with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then enlarging it with fingers without taking off the bladder from the uterus.
- Disposal of amniotic fluid. fetal extraction, using the leverage if necessary.
- Clamping of the umbilical cord and immediate care to the newborn.
- Administration of cefazolin 2g IV and 10 IU oxytocin.
- Afterbirth and revision of the uterine cavity.
- Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.
- Visceral peritonization simple catgut and 2-0 suture in simple running suture.
- Revision of the abdominal cavity.
- Closure of the parietal peritoneum and with simple catgut 2-0 suture in simple running suture.
- Closing the muscular plane is separated into "U", with simple catgut fioa 2-0 points.
- Closing the aponeurosis chrome catgut sutures in one not anchored.
- Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.
- Skin closure is made with nylon suture with 4-0 points Donati modified.
- Dressing kept simple in the early hours.
Surgery (minimally invasive technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
- Traditional Preparation: pubic shaving, prior bladder emptying.
- Asepsis and degermante with alcoholic chlorhexidine.
- The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.
- Cross Opening subcutaneous tissue with electrocautery used in clotting.
- Opening Aponeurosis transversely, hemostasis of bleeding vessels.
- Separation of the Muscles of the median raphe manually, exposure, clamping the parietal peritoneum, small opening with scissors. Through digital dilatation peritoneum is opened across the entire length of the incision.
- Hysterotomies Segment transverse, arcuate, superior concavity, made a small incision with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then enlarging it with fingers without taking off the bladder from the uterus.
- Disposal of amniotic fluid. Fetal extraction, using the leverage if necessary.
- Clamping of the umbilical cord and immediate care to the newborn.
- Administration of cefazolin 1 g IV and 10 IU oxytocin.
- And revision of the uterine cavity.
- Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.
- Revision of the abdominal cavity.
- Closing the aponeurosis chrome catgut sutures in one not anchored.
- Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.
- Skin closure is made with nylon suture with 4-0 points Donati modified.
- Dressing kept simple in the early hours]. Postoperative medication
- Intravenous hydration with 1000 ml of glucose 5% and 500 ml of 0.9% saline solution in drip 60 drops / minute.
- Use (dimethicone) every 8 hours the first dose at 12 hours postoperatively.
- Use of analgesic and anti-spasmodic every 6 hours if needed (Buscopan composts® (scopolamine butylbromide 20mg and dipyrone 2.5 mg).
F-STATISTICAL METHOD The data will be tabulated and subjected to statistical analysis. The level of rejection of the null hypothesis will be set at 5% (α <0.05).
For numeric variables will be used descriptive statistics, with calculations of median, mean and deviation padrão.O Mann-Whitney test is used to compare two independent groups with nonparametric behavior and the chi-square test for categorical variables.
- Conditions
- Pregnancy
- Being tested
- Pfannenstiel cesarean section, Misgav-Ladach cesarean section
- Keywords
- cesarean section, pain, postoperative/diagnosis, pain measurement/methods
- Medical subject headings
- Pain, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfannenstiel cesarean sectionProcedure or surgery
Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment
Misgav-Ladach cesarean sectionProcedure or surgery
Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment
| Study group | Role | What they receive |
|---|---|---|
| Pfannenstiel cesarean section | Active comparator | Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by Pfannenstiel technique. Pain assessment on postoperative hours 6, 12 and 24. Receives: Procedure: Pfannenstiel cesarean section |
| Misgav-Ladach cesarean section | Experimental | Women in 36 to 40 weeks of pregnancy undergoing first cesarean section by minimally invasive technique. Pain assessment on postoperative hours 6, 12 and 24. Receives: Procedure: Misgav-Ladach cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative
Measured: Postoperative 24 hours
Secondary outcomes (1)
time spent in two different techniques for cesarean
compare time spent in each technique, considering only cesarean that spent less than 1 hour
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 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 PregnancyStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Vale do Sapucai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivanildo Archangelo Junior, Universidade do Vale do Sapucai
- Investigators
- IVANILDO ARCHANGELO, Principal investigator, UNIVERSIDADE DO VALE DO SAPUCAÍDaniela F Veiga, MD, PhD, Study chair, Universidade do Vale do Sapucaí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257255
- Sponsor's protocol ID
- cesarean
- Status last verified
- May 2015
- First submitted
- 18 Aug 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment
- ClinicalTrials.gov ID
- NCT02257255
- Acronym / sponsor ID
- cesarean
- Conditions
- Pregnancy
- Keywords
- cesarean section, pain, postoperative/diagnosis, pain measurement/methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidade do Vale do SapucaiUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Oct 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.
Cesarean section is the most performed abdominal surgery in women, worldwide. The World Health Organization (WHO) considers 15% of deliveries the ideal rate of this surgery. However, Brazil presents the highest rates of cesarian section in the world, reaching 85% in hospitals and private clinics.
The most used technique of cesarean section is the known as Pfannenstiel or Classical technique. In 1996, a new technique was described, called Misgav Ladach or minimally invasive technique.
Several studies have show that the minimally invasive technique is faster and promotes lower costs and less intraoperative bleeding. There is no current evidence that this technique is less painful.
This study aims to compare the postoperative pain in both techniques,by means of two pain scales: a one-dimensional scale, the Visual Analogue Scale, and a multidimensional scale, the McGill Scale.
Detailed description
- STUDY Primary, clinical, prospective, randomized, double blind with, controlled, two parallel groups interventional and analytical.
- MATERIAL
A-CALCULATION OF SAMPLE SIZE
Were used to calculate the size of the sample study data Antalon et al. (2001), who also compared the two techniques of caesarean section, and the Student's t-test was used bi flow. Considering a standard deviation of 1.5 points in the Visual Analog Pain Scale, and significant a difference of two points, the calculated number of patients per group was 15, with a significance level of 5% and power of 95 test %.
C RANDOMIZATION AND CONFIDENTIALITY OF ALLOCATION
The allocation will be determined by random sequence generated by computer (BioStat 5.0 software, Mamiraua Institute, Brazil). The sequence had been held by the researcher who will make allocation of patients to groups in caesarean Pfannenstiel or Misgav-Ladach, 15 in each group.
D-PROCEDURES
ANESTHESIA:
In both groups will be performed spinal anesthesia at L2-L4 with heavy bupivacaine 13 mg and morphine 0.1 mg% standardized by the Anesthesiology Service of HCSL.
SURGICAL PROCEDURE:
Surgical procedure (classical technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
- Traditional Preparation: pubic shaving, prior bladder emptying.
- Asepsis with degerminate clorhexidine and alcoholic
- The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.
- Cross Opening subcutaneous tissue.
- Opening Aponeurosis transversely, hemostasis of bleeding vessels.
- Separation by dissection of the anterior rectus sheath muscles of the abdomen to the umbilicus.
- Separation of the muscles of the median raphe manually, exposure, clamping and opening the parietal peritoneum with scissors longitudinally.
- Opening of the visceral peritoneum transversely with scissors, taking off the bladder from the uterus.
- Hysterotomy segment transverse, arcuate, superior concavity, made a small incision with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then enlarging it with fingers without taking off the bladder from the uterus.
- Disposal of amniotic fluid. fetal extraction, using the leverage if necessary.
- Clamping of the umbilical cord and immediate care to the newborn.
- Administration of cefazolin 2g IV and 10 IU oxytocin.
- Afterbirth and revision of the uterine cavity.
- Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.
- Visceral peritonization simple catgut and 2-0 suture in simple running suture.
- Revision of the abdominal cavity.
- Closure of the parietal peritoneum and with simple catgut 2-0 suture in simple running suture.
- Closing the muscular plane is separated into "U", with simple catgut fioa 2-0 points.
- Closing the aponeurosis chrome catgut sutures in one not anchored.
- Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.
- Skin closure is made with nylon suture with 4-0 points Donati modified.
- Dressing kept simple in the early hours.
Surgery (minimally invasive technique)
Once displayed, according to the behavior of the service, this will be performed according to the following surgical technique:
- Traditional Preparation: pubic shaving, prior bladder emptying.
- Asepsis and degermante with alcoholic chlorhexidine.
- The transverse abdominal incision approximately 10 cm, 3-4 cm above the pubic symphysis.
- Cross Opening subcutaneous tissue with electrocautery used in clotting.
- Opening Aponeurosis transversely, hemostasis of bleeding vessels.
- Separation of the Muscles of the median raphe manually, exposure, clamping the parietal peritoneum, small opening with scissors. Through digital dilatation peritoneum is opened across the entire length of the incision.
- Hysterotomies Segment transverse, arcuate, superior concavity, made a small incision with a scalpel and that is complete with Kelly forceps to reach the uterine cavity and then enlarging it with fingers without taking off the bladder from the uterus.
- Disposal of amniotic fluid. Fetal extraction, using the leverage if necessary.
- Clamping of the umbilical cord and immediate care to the newborn.
- Administration of cefazolin 1 g IV and 10 IU oxytocin.
- And revision of the uterine cavity.
- Hysterorrhaphy with Catgut chrome one in a continuous suture not anchored.
- Revision of the abdominal cavity.
- Closing the aponeurosis chrome catgut sutures in one not anchored.
- Approximation of the subcutaneous tissue with 2-0 catgut simple in separate points.
- Skin closure is made with nylon suture with 4-0 points Donati modified.
- Dressing kept simple in the early hours]. Postoperative medication
- Intravenous hydration with 1000 ml of glucose 5% and 500 ml of 0.9% saline solution in drip 60 drops / minute.
- Use (dimethicone) every 8 hours the first dose at 12 hours postoperatively.
- Use of analgesic and anti-spasmodic every 6 hours if needed (Buscopan composts® (scopolamine butylbromide 20mg and dipyrone 2.5 mg).
F-STATISTICAL METHOD The data will be tabulated and subjected to statistical analysis. The level of rejection of the null hypothesis will be set at 5% (α <0.05).
For numeric variables will be used descriptive statistics, with calculations of median, mean and deviation padrão.O Mann-Whitney test is used to compare two independent groups with nonparametric behavior and the chi-square test for categorical variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pfannenstiel cesarean section | Active comparator | Procedure: Pfannenstiel cesarean sectionWomen in 36 to 40 weeks of pregnancy undergoing first cesarean section by Pfannenstiel technique. Pain assessment on postoperative hours 6, 12 and 24. |
| Misgav-Ladach cesarean section | Experimental | Procedure: Misgav-Ladach cesarean sectionWomen in 36 to 40 weeks of pregnancy undergoing first cesarean section by minimally invasive technique. Pain assessment on postoperative hours 6, 12 and 24. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primiparous patients who are undergoing cesarean section
Key exclusion criteria (3 listed)
- Previous pelvic and/or abdominal surgery ;
- Emergency cesarean section, due to placenta previa, fetal distress, cord prolapse or other obstetric emergencies;
- Pregnancies below 36 weeks.
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 |
|---|---|---|
| Pfannenstiel cesarean sectionPain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment | Procedure or surgery | Pfannenstiel cesarean section |
| Misgav-Ladach cesarean sectionPain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment | Procedure or surgery | Misgav-Ladach cesarean section |
Primary outcome
Pain
Time frame: Postoperative 24 hours
pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative
1 secondary outcome
time spent in two different techniques for cesarean
Time frame: 1 hour
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 28 May 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.
IVANILDO ARCHANGELO principal investigator
UNIVERSIDADE DO VALE DO SAPUCAÍ
Daniela F Veiga, MD, PhD study chair
Universidade do Vale do Sapucaí
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pfannenstiel cesarean section and Misgav-Ladach cesarean section in people with Pregnancy, run by Universidade do Vale do Sapucai at 1 site in Brazil.
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 1 inclusion and 3 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 28 May 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 Brazil. 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?
Pain (time frame: Postoperative 24 hours). 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 28 May 2015.