Classic Cesarean Section Versus Minimally Invasive Cesarean Section: Pain Assessment

NCT02257255 | Completed

• 1 other identifier: cesarean
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pregnancy

Keywords

cesarean section; pain, postoperative/diagnosis; pain measurement/methods

Outcome Measures

Primary Outcomes (1)

• Pain

  pain assessment using two kinds of pain scales VAS and McGILL scale at 6, 12 and 24 hours of postoperative

  Postoperative 24 hours

Secondary Outcomes (1)

• time spent in two different techniques for cesarean

  1 hour

Study Arms (2)

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.

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.

Procedure: Misgav-Ladach cesarean section

Interventions

Pfannenstiel cesarean section PROCEDURE

Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment

Pfannenstiel cesarean section

Misgav-Ladach cesarean section PROCEDURE

Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment

Misgav-Ladach cesarean section

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Primiparous patients who are undergoing cesarean section

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Vale do Sapucai: lead

Study Sites (1)

Ivanildo Archangelo Jr

Pouso Alegre, Minas Gerais, 37550-000, Brazil

Location

MeSH Terms

Conditions

Pain; Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• IVANILDO ARCHANGELO

  UNIVERSIDADE DO VALE DO SAPUCAÍ

  PRINCIPAL INVESTIGATOR

• Daniela F Veiga, MD, PhD

  Universidade do Vale do Sapucaí

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 18, 2014
• First Posted: October 6, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BR (1)