The Effect of Rectus Muscle Re-approximation at Cesarean Delivery on Postoperative Pain

February 19, 2022 updated by: Orkun Cetin, Balikesir University

The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial

The Effect of Rectus Muscle Re-approximation on Postoperative Pain Among Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section: A Randomized Prospective Trial.

Cesarean section is the most common surgical procedure performed in women in all around the world. Cesarean delivery rate has increased dramatically worldwide but there is still debate about the optimum operative technique of cesarean section.

Rectus muscle reapproximation, or suturing of the rectus muscles, is performed by many obstetricians in several countries, presumably to reduce the risk of persistent rectus muscle diastasis. However, there was a few studies about the short and long term effects of rectus muscle reapproximation in the literature.

On this account, the investigators aimed to design a randomized prospective trial about the effect of rectus muscle re-approximation on postoperative pain among primigravida singleton pregnancies who underwent elective cesarean section.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, randomized controlled trial conducted at Balikesir University Medical Faculty Department of Obstetrics and Gynecology at Balikesir, Turkey between January 2021 and March 2022. The singleton pregnant women undergoing scheduled primary cesarean section who are not in labor and consented to the trial are randomly assigned to receive rectus muscle reapproximation versus no reapproximation.

Gestational age is detected by the first day of last menstrual period and confirmed by first trimester ultrasonography measurements. The pregnant women who recruited this study would have no maternal accompanying conditions, such as hypertensive disorders of pregnancy, preterm rupture of membranes, Type 1 diabetes mellitus, gestational diabetes mellitus, reno-vascular disorders, sickle-cell anemia, collagen-vascular diseases, hereditary or acquired thrombophilia, congenital abnormalities and multiple gestations. Randomization would be conducted through sequentially numbered opaque envelopes generate by a study nurse in blocks through a random numbers table, in a 1:1 ratio.

Surgical techniques at cesarean section are standardized within the study and included closure of the parietal peritoneum and one-layer uterine closure. For women randomized to rectus muscle reapproximation, surgeons will use 2.0 Vicryl (Ethicon) for continuous suturing to reapproximate the rectus muscles. All surgeries were performed by an attending physician and a resident physician.Intraoperative analgesia was standardized to spinal anesthesia. Postoperative pain management is standardized by using our clinic's postoperative cesarean section protocol.Patients with pain unresponsive to the aforementioned treatment could receive opioids as necessary. Visual analog scale (VAS)scores are assessed through inperson interview in the hospital by a member of the study team at 24 and 48 hours after cesarean section.Total opioid use, total milligrams of nonsteroid antiinflammatory drugs (NSAIDs) and acetaminophen use are also tracked and summed.

The primary outcome will be the changes in total NSAID, opioid and acetaminophen use of the patients between the groups (rectus reapproximation and no rectus reapproximation groups). The investigators will also analyze the VAS scores of the patients 24 and 48 hours after surgery between the groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Balikesir, Turkey, 65080
        • Recruiting
        • Balikesir University Medical Faculty Department of Obstetrics and Gynecology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

This study is a prospective, randomized controlled trial conducted at Balikesir University, Department of Obstetrics and Gynecology at Balikesir Turkey. Pregnant women undergoing elective first cesarean section who were not in labor and consented to the trial were randomly assigned to receive rectus muscle reapproximation versus no reapproximation.

Description

Inclusion Criteria:

  • Primigravida pregnancies
  • Singleton pregnancies
  • Aged between 18- 45
  • Term pregnancy
  • First cesarean section
  • Elective
  • Without any comorbidity (Thyroid disorders, Diabetes Mellitus, Hypertension, Preterm delivery, etc.)

Exclusion Criteria:

  • active labor,
  • Prior cesarean section
  • chronic analgesia use,
  • vertical skin incision at cesarean,
  • allergy to opioid or nonsteroidal anti-inflammatory drugs (NSAIDs),
  • prior laparotomy,
  • class III obesity (body mass index above 40).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
undergoing rectus muscle reapproximation
Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section with rectus muscle reapproximation procedure
Procedure: Rectus muscle reapproximation at cesarean section
Rectus muscle reapproximation: Continuous Suturing of rectus muscles with 2.0 Vicryl (Ethicon) at Cesarean section.
not undergoing rectus muscle reapproximation
Primigravida Singleton Pregnancies Who Underwent Elective Cesarean Section without rectus muscle reapproximation procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative analgesia
Time Frame: postoperative period first 48 hours.
Drugs (mg)
postoperative period first 48 hours.
Operation time
Time Frame: During operation
Operation time: Hours
During operation
Changes in hemoglobin level
Time Frame: Intraoperative and postoperative period (including postoperative 48 hours)
mg/dl
Intraoperative and postoperative period (including postoperative 48 hours)
Length of hospital stay
Time Frame: Throughout postoperative period, an average of 2 days after surgery
Length of hospital stay: Days
Throughout postoperative period, an average of 2 days after surgery
Occurence of postoperative complication
Time Frame: Throughout postoperative period, an average of 7 days after surgery
Hematoma, dehiscense, blood transfusion, etc.
Throughout postoperative period, an average of 7 days after surgery
Postoperative pain
Time Frame: Visual analog score of the patient after 24 hours after cesarean section
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Visual analog score of the patient after 24 hours after cesarean section
Postoperative pain
Time Frame: Visual analog score of the patient after 48 hours after cesarean section
Visual Analog Scale Score: Units on a Scale (minimum score: 1- maximum score: 100)
Visual analog score of the patient after 48 hours after cesarean section

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balikesir University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • rectus1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No: There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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