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临床试验/NCT04095897
NCT04095897已完成不适用

Does Pecs II Block Reduce the Incidence of Post Mastectomy Pain Syndrome (PMPS)? A Cross Sectional Study

Universiti Kebangsaan Malaysia Medical Centre1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2018年3月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
288
试验地点
1
主要终点
Incidence of PMPS

研究概览

简要总结

Post mastectomy pain syndrome (PMPS) is a chronic pain condition that develops after breast cancer surgery. The objective of this study was to determine if Pecs II block administered prior to general anesthesia (GA) reduced the incidence of PMPS after mastectomy and axillary clearance (MAC) when compared with conventional analgesic therapy.

详细描述

This cross sectional study was approved by the research and ethics committees in both institutional and national levels. This project was registered under National Medical Research Register (NMRR), Ministry of Health Malaysia.

Patients who underwent MAC from July 2015 - June 2017 in Hospital Kuala Lumpur (HKL) were recruited. In order to standardize surgical technique and reduce confounding factors, case selection was only limited to unilateral MAC. Other breast cancer surgeries, such as wide local excision, modified radical mastectomy (MRM) and lumpectomy, were excluded. Patients with the following characteristics and problems were excluded from our study - past history of chronic pain and on regular analgesics, chemotherapy or radiotherapy before surgery, surgical complications (such as infection or wound breakdown) or cancer recurrence, history of psychiatric illness, inability to be contacted, inability or unwillingness to participate in the study.

There is currently no standard definition for this chronic pain syndrome. Depending on the definitions applied, patient selection and methods used, the incidence varies. The definition of PMPS used in this study was modified from International Association for the Study of Pain19 (IASP) and other studies.9,20 In our study, PMPS is taken as chronic post surgical pain in the anterior aspect of the thorax, axilla, and/or upper half of the arm beginning after mastectomy, without objective evidence of local abnormality, persisting either continuously or intermittently for more than three months after surgery, and may be associated with allodynia or sensory loss.

Questionnaire used in this study was obtained with permission from Dr Manoj Kumar Karmakar, the author of a previous study on the effect of thoracic paravertebral block (TPVB) on chronic pain post mastectomy.21 It was prepared in both English and Malay versions (Appendix 1) to cater for our local population. The English version was translated to Malay using forward and retrograde translation methods to check the reliability and precision of the words by four independent translators who were bicultural Malay speakers with a good command of English. The translation was further evaluated by a panel of experts in the field of Regional Anesthesia and Pain Management to verify the idiomatic and cross-cultural equivalence to the English version. Seven respondents were then recruited to assess face validity of the questionnaire. Repeat evaluation was done until respondents understood all the questions in the process of content validation. No modification was needed as the first draft of questionnaire was well understood by all respondents. Internal consistency reliability and construct validation was done using Cronbach's alpha, Kaiser-Meyer-Olkin (KMO) test and Bartlett's test of sphericity.22 The KMO value of 0.56 and the significant Bartlett's test of sphericity (P< 0.001) in this validation was acceptable. Cronbach's alpha was 0.736, indicating good internal consistency.

Personal details, medical history and contact number of all patients who underwent MAC within the specified period were collected from patient's medical records with the permission from the Head of Breast and Endocrine Unit, Department of General Surgery, HKL. Each patient who fulfilled the selection criteria was assigned a study number and grouped into either conventional analgesic therapy (Group A) or Pecs II block (Group B).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • patient underwent unilateral mastectomy for breast carcinoma

排除标准

  • past history of chronic pain and on regular analgesics, chemotherapy or radiotherapy before surgery, surgical complications (such as infection or wound breakdown) or cancer recurrence, history of psychiatric illness, inability to be contacted, inability or unwillingness to participate in the study

结局指标

主要结局

Incidence of PMPS

时间窗: 2 years

Incidence of Post mastectomy pain syndrome (PMPS)

次要结局

  • Severity of PMPS(2 years)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Sponsor

研究点 (1)

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