Randomized Clinical Trial: Effect of an Exercise Routine on Postoperative Shoulder Pain in Total Laparoscopic Hysterectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Shoulder pain
研究概览
简要总结
This is a clinical trial aimed at understanding the impact of a shoulder exercise routine on postoperative shoulder pain in patients who have undergone laparoscopic hysterectomy.
**Main Questions:**
1. Does implementing a shoulder exercise routine immediately after laparoscopic hysterectomy reduce postoperative shoulder pain?
**Brief Explanation:** We want to see if doing shoulder exercises right after laparoscopic hysterectomy can help reduce the pain they might feel in their shoulders. This kind of pain can happen because of the gas used during the surgery. Using exercises could be a cost-effective and easy way to help patients recover better after the surgery.
**Hypothesis:** We think that doing shoulder exercises right after laparoscopic hysterectomy will lower the amount of shoulder pain patients experience after the surgery.
**Objective:** Our goal is to find out if a shoulder exercise routine can make a difference in how much shoulder pain patients have right after laparoscopic hysterectomy.
**How We'll Do It:** This study aims to evaluate the impact of a shoulder exercise routine on reducing postoperative shoulder pain in women who have undergone total laparoscopic hysterectomy at the National Institute of Perinatology. Recognizing the high prevalence and intensity of post-laparoscopy shoulder pain, the study compares the effectiveness of shoulder exercises to hand exercises in managing this pain. Patients, selected based on specific inclusion and exclusion criteria, will be randomly assigned to either the shoulder or hand exercise group. The exercise regimen involves performing specific movements at regular intervals during the immediate postoperative period, except at night. Pain intensity will be measured using a Visual Analog Scale at various intervals postoperatively. The study controls for several variables, including visceral and incisional pain, duration of pneumoperitoneum, analgesic use, and patient characteristics like BMI and comorbidities, to ensure a comprehensive understanding of the exercises' effectiveness. The hypothesis tests whether shoulder exercises can reduce shoulder pain more effectively than hand exercises. This research could have significant implications for enhancing recovery and pain management strategies post-laparoscopy.
详细描述
Main Objective
To evaluate the effect of a shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy at the National Institute of Perinatology
Specific Objectives:
- Describe the frequency and intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Determine the effect of the shoulder exercise routine versus a hand exercise routine on the intensity of shoulder pain in women postoperatively following total laparoscopic hysterectomy.
- Evaluate the adjusted effect of the proposed intervention on pain after identifying potential confounding variables. Postoperative management will be similar in both intervention groups, so we do not expect to make adjustments. In the event that confounding variables are identified, we will address them accordingly.
Hypothesis:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing uncomplicated total laparoscopic hysterectomy at INPer for benign pathology.
- •Mixed anesthesia.
- •Placement of shoulder pads on the surgical table during surgery.
- •Adults who agree to participate and sign informed consent.
排除标准
- •Patients with preoperative shoulder pain.
- •Patients who had intraabdominal CO2 pressure greater than 15 mm Hg during surgery.
- •Patients who received a postoperative analgesia pump.
- •Patients participating in another protocol
结局指标
主要结局
Shoulder pain
时间窗: 6 hours, 24 hours, and 7 days postoperatively
Shoulder pain referred by the patient on a Visual Analog Scale (VAS) ranging from 0 to 10. The VAS is a tool used to help a person assess the intensity of certain sensations and feelings, such as pain. It consists of a straight line where one end represents the absence of pain, and the other end represents the worst imaginable pain. The patient marks a point on the line that corresponds to the amount of pain they feel in their shoulders.
次要结局
- Visceral Pain(6 hours, 24 hours, and 7 days postoperatively)
- Incisional Pain(6 hours, 24 hours, and 7 days postoperatively)
研究者
Andrea Alicia Olguin Ortega
MD MSC
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
