Low Versus Standard Intra-Abdominal Pressure During Gynecologic Laparoscopy: A Randomized Controlled Trial of Postoperative Pain and Recovery Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 37
- 试验地点
- 2
- 主要终点
- PAIN OUT questionnaire
研究概览
简要总结
The goal of this clinical trial is to learn if the level of intra-abdominal pressure during benign gynecologic laparoscopic surgery impacts postoperative pain.
The main question it aims to answer is:
• Does use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure impact postoperative pain?
Researchers will compare the use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure.
Participants will:
- Undergo their regular scheduled gynecologic laparoscopic surgery
- Complete pain measures one hour, 3 hours, and 24 hours after surgery
详细描述
Participants will be randomized into one of two experimental groups using a computer-generated allocation list: a low-pressure group (8 mmHg) or a standard-pressure group (15 mmHg). As part of standard care, many surgeons more often use 15 mmHg which is why this is named as our standard-pressure group. Some surgeons use low-pressure varying from 8 mmHg through 12 mmHg which is why our 8 mmHg is named the low-pressure group. The 8 mmHg is the most common acceptable low-pressure approach reported in the surgical literature. All surgeries will begin with standard insufflation at 15 mmHg to achieve safe abdominal access. Once the operative field is established, if necessary, the pressure will be adjusted according to the assigned group. For those surgeons who use 8 mmHg, standard care is to start at 15 mmHg and then to adjust to the lower pressure of 8 mmHg. Our proposed approach is consistent with standard clinical protocol. General anesthesia will be administered per institutional protocol, and local anesthetic will be applied to all trocar sites.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following.
- •Salpingectomy
- •Cystectomy
- •Oophorectomy
- •Myomectomy
- •Hysterectomy.
- •Only those who speak English or Spanish will be recruited, as our validated questionnaires are only available in those languages.
排除标准
- •Participants with the following diseases will be excluded due to their diseases having pain that may strongly interfere with their perception of pain in the area of surgery.
- •Arthritis
- •Metastatic cancer
- •Pelvic floor disease
- •Headache disorders
- •Herpes zoster or shingles
- •Frozen shoulder
- •Complex regional pain syndrome (CRPS)
- •Slipped disc
- •Sickle cell disease
- •Trigeminal neuralgia
- •Fibromyalgia.
研究组 & 干预措施
standard-pressure group
15 mmHg pressure
干预措施: abdominal pressure (Procedure)
low-pressure group
8 mmHg
干预措施: abdominal pressure (Procedure)
结局指标
主要结局
PAIN OUT questionnaire
时间窗: Perioperative/Periprocedural: Three hours after surgery completed
Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels.
次要结局
- PAIN OUT questionnaire(Perioperative/Periprocedural: 24 hours after surgery completed)
- Numerical rating scale for pain location in the abdomen(Perioperative/Periprocedural: One hour after surgery)
- Numerical rating scale for pain location in the shoulder(Perioperative/Periprocedural: One hour after surgery)
- Visual analog scale for pain location in the abdomen(Perioperative/Periprocedural: 24 hours after surgery completed)
- Length of hospital stay(Perioperative/Periprocedural)
- Complications(Perioperative/Periprocedural)
- Hospital Readmission(Perioperative/Periprocedural)
- Use of non-medicine methods to relieve pain(Perioperative/Periprocedural)
- Overall Quality of Surgical Visual Field(Perioperative/Periprocedural)
研究者
PETR ITZHAK
Attending Physician
Nassau University Medical Center