Association of Preoperative Pain With Moderate to Severe Acute Pain After Laparoscopic Cholecystectomy:a Prospective Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Occurrence of acute moderate to severe postoperative pain.
研究概览
简要总结
Despite advancement in perioperative pain management, more than half of the patients still report moderate-severe pain after surgery. Among several risk factors, pre-existing pain has consistently been shown to predict postoperative severe pain.If one can predict the patients who will experience more post-operative pain, then a more aggressive pain management strategy can be adopted perioperatively. This would improve patient satisfaction and prevent poor outcomes such as chronic pain after surgery. Therefore, our primary aim is to find out whether presence of pre-existing preoperative pain would predict moderate-severe acute pain after laparoscopic cholecystectomy. Moreover, we plan to use Patient Reported Outcomes Measurement Information System (PROMIS) scale to assess preoperative pain intensity and pain-related behaviors.
Primary &Secondary Objectives:
Primary objectives To investigate the association between preexisting preoperative pain (more than 3 months duration) and postoperative moderate-severe acute pain after laparoscopic cholecystectomy.
Secondary objectives .1. To investigate the association between preoperative PROMIS(patient reported outcome measurement and information system) domain (PROMIS pain intensity score, PROMIS pain interference score, PROMIS pain behavioural score) and postoperative moderate-severe acute pain after LC.
-
To examine baseline demographic, clinical, psycho-behavioural features and intraoperative factors in relation to dynamic moderate to severe pain after LC.
-
To identify perioperative predictors for acute postsurgical pain. 4. To find out the incidence of shoulder tip pain after LC.
详细描述
Patients who are 18 years of age or more, of ASA 1, 2 and 3, and scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be enrolled in this prospective observational study. Perioperative anaesthesia management will be standardized for all patients.
Variables such as age, sex, preexisting preoperative pain (chronic or subacute), preoperative PROMIS pain intensity, PROMIS behavior, PROMIS interference, PROMIS depression, PROMIS sleep disturbance, APAIS score, catastrophizing pain score, neuroticism (EPQRS score), preoperative pain sensitivity, an expectation of the postoperative pain and intraoperative surgical variables will be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients undergoing laparoscopic cholecystectomy.
- •Age group (more than or equal to 18 years)
- •ASA physical status 1, 2 and
- •Ability to use NPRS scale, PROMIS scale, pain catastrophizing scale, APAIS, neuroticism EPQRS scale, and to understand and follow simple instructions.
排除标准
- •All patient with
- •Not willing to participate in the study
- •Severe Neurological and Psychiatric disorder(eg. dementia)
- •Pregnant women
- •Acute cholecystitis managed conservatively.
- •Cognitive impairments (lack of capacity to provide informed consent)
- •Choledocholithiasis
- •Features of obstructive jaundice.
- •Unable to communicate (eg. Language barrier or deaf)
- •Open cholecystectomy or laparoscopic cholecystectomy converted to open cholecystectomy
结局指标
主要结局
Occurrence of acute moderate to severe postoperative pain.
时间窗: up to 24 hours postoperatively.
numerical pain rating scale (NPRS) more than or equal to 4.
次要结局
- incidence of shoulder tip pain.(up to 24 hours postoperatively.)
- Risk factors associated with moderate to severe pain after laparoscopic cholecystectomy(up to 24 hours postoperatively)
研究者
BISHAL NEPALI
principal investigator
B.P. Koirala Institute of Health Sciences