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临床试验/NCT05334797
NCT05334797已完成不适用

The Effect of Hot Application on Shoulder Pain and Analgesic Use After Laparoscopic Upper Abdominal Surgery

Cukurova University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
change of pain

研究概览

简要总结

The aim of this study; To evaluate the effect of hot application on postlaparoscopic shoulder pain and analgesic use in patients undergoing upper laparoscopic surgery in general surgery.

详细描述

Among the advantages of laparoscopic surgery; smaller incisions, less postoperative pain, less need for analgesia, shorter hospital stay, earlier return to normal activities and lower morbidity. However, laparoscopic surgery is associated with postoperative shoulder pain, which is rarely seen in open surgeries. The precise mechanism of postlaparoscopic shoulder pain (PLOA) is unclear, but it is believed that the carbon dioxide remaining after laparoscopic surgery causes shoulder pain by causing irritation of the phrenic nerve. In some cases, PLOA may cause more discomfort to the patient than incisional pain.

Hot application is an effective method used to relieve pain. Hot application activates the gate control mechanism, stimulating tactile receptors, reducing ischemic pain with vasodilation, removing metabolic wastes, increasing the release of endorphins, eliminating muscle spasm, reducing effects such as pressure, stretching and hypoxia on nerve endings as a result of changes in the viscoelastic properties of tissues, raising the pain threshold, It reduces or relieves pain by sedating and creating relief in the patient.

Hot application is easy to use, inexpensive, requires no prior application, and has minimal adverse side effects when used correctly. Heat sources include a hot water heater, an electric heating pad, a warm blanket, and a warm bath or shower. In addition to being used as a pain reliever, heat is used to relieve chills or shivering, reduce joint stiffness, reduce muscle spasm, and increase connective tissue extensibility.

In the study of Mohamed et al., in which they examined the effect of hot application and early mobilization on shoulder pain, in the experimental group patients who received hot application; Postoperative shoulder pain was found to be significantly less than the control group at different evaluation times at 4 hours after surgery and at 6, 12 and 24 hours (p<0.001).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Aged ≥18 years. Scheduled for elective laparoscopic upper abdominal surgery. No previous laparoscopic surgery. ASA physical status I-III. Able to understand and complete the study assessments. Provided written informed consent to participate in the study.

排除标准

  • •Undergoing emergency surgery. Cognitive impairment preventing reliable pain self-report.

研究组 & 干预措施

control group

No Intervention

Participants allocated to the control group receive standardized routine postoperative care only. Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS) at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours. Pain intensity is assessed before the administration of any additional analgesic medication. Postoperative analgesic administration is monitored throughout the 24-hour observation period, including whether additional analgesia is administered and, when administered, whether the medication is classified as opioid or non-opioid.

Hot application

Experimental

Participants allocated to the intervention group receive standardized routine postoperative care plus local heat therapy. Local heat therapy is initiated within the first postoperative hour using a hot-water bag covered with a protective sheath and maintained at a maximum temperature of 55°C. The hot-water bag is positioned beneath the shoulder and applied for 15-20 minutes. The intervention is repeated at 2-hour intervals during the first 24 postoperative hours or until complete resolution of shoulder pain, whichever occurs first. Skin integrity and patient tolerance are monitored before, during, and after each application. Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS) at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours. In the intervention group, pain intensity is assessed before each heat application and, in both groups, before administration of any additional analgesic medication. Postoperative analge

干预措施: Local heat therapy (Other)

结局指标

主要结局

change of pain

时间窗: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).

Post-laparoscopic shoulder pain intensity is assessed using the Visual Analogue Scale (VAS), consisting of a 10-cm horizontal line ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate greater pain intensity. Pain intensity is assessed at six predefined postoperative intervals: 0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours.

analgesic consumption

时间窗: During the first 24 postoperative hours (0-2, 2-4, 4-8, 8-12, 12-18, and 18-24 hours).

Postoperative analgesic administration is recorded at each predefined assessment interval as whether additional analgesia is administered and, if administered, whether the analgesic is classified as opioid or non-opioid.

change of pain

时间窗: 24 hours

Numerical Pain Rating Scale (NRS) The form used by Williamson \& Hoggart (2005) to assess pain, patients will be asked to select a number from 0 to 10 that best describes their current pain. 0 means no pain and 10 means severe pain. It will be scored as no pain (0), mild pain (1-3), moderate (4-7) and severe pain (8-10).

analgesic consumption

时间窗: 24 hours

analgesic consumption form

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Derya Gezer

Assistant Professor

Cukurova University

研究点 (1)

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