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临床试验/CTRI/2024/08/071824
CTRI/2024/08/071824
尚未招募
不适用

Patient satisfaction with postoperative pain management at a Tertiary Cancer Centre: A Prospective Audit

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2024年8月12日最近更新:

概览

阶段
不适用
状态
尚未招募
入组人数
2,000
试验地点
1
主要终点
Percentage of patients satisfied with acute pain services provided to them postoperatively

概览

简要总结

INTRODUCTION:

Pain is an inevitable outcome of surgery. Patient’s who undergo surgery will invariably have pain because of the intra operative tissue handling, which leads to tissue damage results in pain. Pain relief has been accepted by the World Health Organization as a basic human right and is now considered as the 5th Vital sign (1)Globally, postoperative pain is a major concern and is well known that untreated or suboptimal treated postoperative pain , could lead to a variety of negative consequences such as, myocardial ischemia, pulmonary complications, delayed mobilization with increased incidence of thromboembolic episodes , impair rehabilitation, prolong hospital stay decrease quality of life and increase the risk for the development of persistent postsurgical pain and thereby chronic pain (2) However, Pain relief and the procedures done thereof, are also associated with certain side effects such as sedation, respiratory depression, postdural puncture headache (PDPH), nausea, vomiting etc.  Traditionally, pain scores and  side effects were the major outcome measures for service improvement, however in recent times patient satisfaction is considered an important tool to measure outcomes.

Patient satisfaction is the measure of the extent to which the patient is content with the health care they receive from the provider. (3) Pain management may be affected by multiple factors such as the gender ,age, preoperative expectations, information given prior to surgery, ASA status, pain medications, type of surgery & anesthesia, communication of staff with patient, prior experience of pain and current pain relief which may affect patient satisfaction.

In 1991, the American Pain Society (APS)  published its first American Pain Society-Patient Outcome Questionnaire (APS-POQ) as part of quality assurance (QA) standards for the treatment of acute and cancer pain to assist health care organizations to explore patient experiences and outcomes (4). The revised version American Pain Society-Patient Outcome Questionnaire revised (APS-POQ-R) measures 6 aspects of quality, including (1) pain severity and relief; (2) impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of information about pain treatment. (5) ability to participate in pain treatment decisions; and (6) use of non-pharmacological strategies. (5). The APS-POQ-R has since been found to be easy to administer and useful for quality evaluation in postoperative pain management. (6)

The revised version of the questionnaire APS-POQ-R has been translated & validated in Indian languages, chiefly Hindi & Marathi (7)

At our hospital approximately 9652 surgeries are performed annually. Majority of the patients, especially those undergoing thoracic, GI, Gynecology Urology and limb surgery have their postoperative pain managed by the Acute Pain Service (APS). In the last 6 months a total of 1797 patients were managed by the APS team. The APS team of doctors and a pain nurse visits the patients for the first 3 -4 postoperative days and sometimes longer as per need with the chief aim of ensuring good pain relief with no adverse effects.  Pain scores, catheter site check (epidural or otherwise) and any related side effects are documented and managed by the team. The pain scoring is based on a ten point numerical rating scale. The pain considered mild if scores are 3 or less, moderate when scores are 4 but less than 7 and severe when scores are greater than 7 on a Numerical rating scale which is a ten point scale from 0-10. Pain is assessed regularly after shifting  to the PACU, and at regular intervals in the postoperative period .

Despite improved knowledge, and advances with better options and modalities for postoperative pain management, suboptimal satisfaction with postoperative pain management is quite common. (8)

We therefore aimed to assess the level of satisfaction among our patients with the care provided by the Acute Pain Service.

AIM

Primary:

To assess patient satisfaction with the postoperative pain management by the APS using the APS-POQ-R that is percentage of patients satisfied with acute pain services.

Secondary: to identify

1.     Predictors of satisfaction as obtained from the satisfaction questionnaire

2.     Pain relief in first 48 hours based on Pain score (average & worst in first 48 hours)

3.     Side effects of pain management techniques/drugs

 METHODOLOGY

Prospective observational study will be conducted over a period of 6 months after Institutional Ethics Committee approval and CTRI registration. Eligible patients will be enrolled after obtaining their consent.

The data will be retrieved from EMR and APS data and revised APQ form which will be administered by Pain sister under APS team on postoperative day 3 or post catheter removal. The information regarding age, sex, body mass index, ASA grading, name of surgery and other modalities used with general anesthesia to reduce postoperative pain will be collected. The postoperative pain on the day of surgery and POD 1 and POD2 will be recorded. The revised APQ form will be filled by patients with help of pain nurse in the language best suited to them that is Hindi, English, Marathi.

CONSENT

Written informed consent will be obtained from each study participant after a clear explanation of what they would have to do and take part in the study. Anyone not willing to participate in the study will be informed that they have the full right not to participate or stop at any time and those who are not voluntary will be excluded. Confidentiality will be guaranteed by keeping the secrecy of personal identification, keeping the completed questionnaires and checklist results in a well-secured area.

SAMPLE SIZE

Based on the departmental data, we estimate to screen more than 2000 patients in 6 months and therefore approximately 2000 patients can be recruited in 6 months (whichever is earlier).

STATISTICS

Categorical data will be reported as counts (percentage) and continuous variables will be reported as Mean (sd) or Median (IQR) depending on the distribution of data.

The Primary Objective Patient satisfaction is an item measured in the APS-POQ-R will be presented as mean(sd) or median(IQR) based on the distribution of data. Linear and logistic regressions will be used to identify the potential risk factors and subscale scores from the APS-POQ-R (except “patient satisfaction”), and surgical and demographic factors that will be predictors of satisfaction.  Risk factors significantly associated with patient satisfaction in univariate analysis were included in multiple linear regression, including gender, diagnosis (cancer), and chronic pain history, as well as all other items from the APS-POQ-R (except “patient satisfaction”). Average & worst in first 48 hours Pain score will be presented as mean(sd) or median(IQR) based on the distribution of data. Side effects of pain management techniques/drugs will be presented as counts and percentages. Normality assumptions will be assessed using the Kolmogorov-Smirnov test. P value set at 5% level of significance. All data analysis will be carried out using SPSS version 25.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Adult patients more than 18years old
  • Those undergoing major surgery
  • Those not likely to require overnight ventilation beyond the night of surgery.

排除标准

  • Patients less than 18 years of age
  • Those requiring ventilation beyond the night of surgery
  • Postoperative patients not under APS care
  • Refusal of consent
  • Cognitively impaired.

结局指标

主要结局

Percentage of patients satisfied with acute pain services provided to them postoperatively

时间窗: on postoperative day 3 or post regional/epidural catheter removal

次要结局

  • 1. Predictors of satisfaction as obtained from the satisfaction questionnaire(On postoperative day 3 or post catheter removal)
  • 2. Pain relief in first 48 hours based on Pain score (average & worst in first 48 hours)(AT post operative 48 hours)
  • 3. Side effects of pain management techniques/drugs(on postoperative day 3 or post catheter removal)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aparna Chatterjee

Tata Memorial Centre

研究点 (1)

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