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临床试验/NCT05260970
NCT05260970Unknown不适用

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

Balikesir University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Postoperative analgesia

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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).

结局指标

主要结局

Postoperative analgesia

时间窗: postoperative period first 48 hours.

Drugs (mg)

Changes in hemoglobin level

时间窗: Intraoperative and postoperative period (including postoperative 48 hours)

mg/dl

Operation time

时间窗: During operation

Operation time: Hours

Length of hospital stay

时间窗: Throughout postoperative period, an average of 2 days after surgery

Length of hospital stay: Days

Occurence of postoperative complication

时间窗: Throughout postoperative period, an average of 7 days after surgery

Hematoma, dehiscense, blood transfusion, etc.

Postoperative pain

时间窗: 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)

次要结局

未报告次要终点

研究者

发起方
Balikesir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Orkun Cetin

Associate Professor

Balikesir University

研究点 (1)

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