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

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: Recruiting
• Conditions: Suturing of Rectus Muscle at Cesarean Section
• Intervention / Treatment: Procedure: Rectus muscle reapproximation at cesarean section

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: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Orkun Çetin; Phone Number: 05325910205; Email: drorkuncetin34@hotmail.com

Study Locations

• Turkey
  • Balikesir, Turkey, 65080
    • Recruiting
    • Balikesir University Medical Faculty Department of Obstetrics and Gynecology
    • Contact: Orkun Çetin; Phone Number: 05325910205; Email: drorkuncetin34@hotmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Postoperative analgesia	Drugs (mg)	postoperative period first 48 hours.
Operation time	Operation time: Hours	During operation
Changes in hemoglobin level	mg/dl	Intraoperative and postoperative period (including postoperative 48 hours)
Length of hospital stay	Length of hospital stay: Days	Throughout postoperative period, an average of 2 days after surgery
Occurence of postoperative complication	Hematoma, dehiscense, blood transfusion, etc.	Throughout postoperative period, an average of 7 days after surgery
Postoperative pain	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	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

• Sponsor: Balikesir University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: February 19, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative Pain; Cesarean section; Rectus Muscle; Rectus Muscle Re-approximation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID 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