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Completed

NCT Number: NCT03961269

Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan

This study is designed to evaluate the frequency and presentations of chronic persistent pain in patients after breast cancer surgery at our tertiary care hospital. Results of this study will help us to understand the magnitude of problem in our population and making institutional guidelines for appropriate management of such patients.

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Key information

Age range

30 year–75 year

Sex eligibility

Female

Study type

Observational

About this study

After approval from the Departmental Research Committee and Institutional Ethical Review Committee all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy) from 1st July 2016 to 30th December 2016 will be enrolled in this audit. Inclusion of patients will be done once operative procedure is finalized and consent taken in breast clinic. Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

Data will be obtained from patient's medical record, interview of patient on follow up visit at breast clinic and telephonic communication with patient. Variables have been defined and a special form has been designed for data collection. All patients will be followed for next three months and those who have persistent pain will be followed for six months after operation.

Follow up information will be obtained from patient visiting breast clinic. For any missing data patient's medical records will be reviewed and patient will be contacted to know if they have chronic post-surgical pain or not. Audit forms will be filled by authors according to their availability. The primary investigator or author at breast clinic will keep all forms for safe record keeping which shall later be used for data analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)

Exclusion criteria

  • Those patients who did not give consent and those patients who need reoperation on same side for recurrence of cancer or any reason will be excluded from this study.

Treatment and study plan

Primary outcomes

  1. To determine the frequency of persistent pain in patients after breast cancer surgery

    Time frame: 3 to 6 months

    After breast cancer surgery, patients were followed for next 3 months and those patients who developed persistent pain were followed for up to 6 months via pre designed questionnaire

Secondary outcomes

  1. To observe the distribution and characteristics of pain in these patients.

    Time frame: 3 to 6 months

    After breast cancer surgery, patients were followed to observe the distribution and characteristics of pain on pre-designed questionnaire

Sponsors and collaborators

Lead sponsor

Ali Sarfraz Siddiqui

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 23, 2019
Registry last updated
May 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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