Clinical trial NCT03961269: Frequency and Presentations of Chronic Pain Following Breast Cancer Surgery: An Observational Study in a Tertiary Care Hospital of Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Chronic Pain
Keywords: Breast cancer surgery
Persistent pain
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult female patients with known carcinoma of breast who are scheduled for elective definitive breast cancer surgery (Mastectomy)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the frequency of persistent pain in patients after breast cancer surgery
timeFrame: 3 to 6 months
Secondary outcomes:
measure: To observe the distribution and characteristics of pain in these patients.
timeFrame: 3 to 6 months
Other outcomes:
Locations:
Study officials:
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