Postmastectomy Pain Syndrome in an Indian Cancer Hospital
কীওয়ার্ডস
বিমূর্ত
বর্ণনা
Tata Memorial Hospital, a 629 bed tertiary cancer institute conducts approximately 6000 surgeries per year. Approximately 4000 (4239 in 2015) patients with suspected breast cancers register annually at the hospital and around 2800 breast cancer surgeries are performed every year. Very few studies on PMPS in Indian population exist. The investigators therefore, aim to identify the incidence of post mastectomy pain syndrome PMPS) in this population. The investigators also aim to identify the severity of postmastectomy pain along with its impact on daily function and quality of life.
STUDY DESIGN:
Prospective study over 12 months with follow up until 6th month from enrollment with interim analysis in the month of November for presentation of the CoPI's thesis.
MATERIALS & METHODS:
Prospective study over a period of 12 months from commencement of study after Institutional ethics committee approval, at Tata Memorial hospital and ACTREC. Female patients scheduled for undergoing surgery for breast cancer conservative and radical and willing to participate will be enrolled in the study after obtaining a written informed consent. Pain scores will be assessed using Numerical rating scale [with pain score 1-3 mild, 4 to 6 moderate and 7 and above severe]. History of predisposition to recurrent headaches and dysmenorrhea will be noted. Details of disease stage, chemotherapy and/or radiotherapy will also be documented from the Electronic medical records. Analgesia will be managed by the primary surgical team as is currently being done. The analgesia administered to the patient will also be recorded. participants noted to have moderate to severe pain despite analgesics prescribed by the surgical team will be referred to the acute pain service (APS) for further management.
Postoperative pain severity both the average & worst pain will be recorded at discharge from hospital, 1st, 4th and 6th month after the surgery. The Details of postoperative pain analgesic use and effect on daily function will be documented with the help of postal cards with questionaires in envelop addressed to the investigators. Study will emphasize on the type, severity, the site of pain whether, lateral or anterior chest wall, axilla, ipsilateral medial upper arm or back, the type of pain (burning, tingling, shooting, stabbing etc) and effects on daily function and quality of life. Details of postoperative hematoma, infection, local recurrence will also be recorded from the history, electronic medical records and documents of participants. Details of postoperative chemotherapy and radiation will also be obtained from patient's notes and the electronic medical record All participants will be administered the short form of the Brief Pain inventory [BPI], EORTC QLQ 30, preoperatively, at 1 month, 4 months & 6 months after surgery.
The Brief pain inventory {BPI} (obtained with permission from MD Anderson), which assesses the severity of pain and impact of pain on daily functions will be administered to the participant in the language familiar to them, preoperatively, at 1 month, 4th and 6th month postoperatively. The short form comprises of nine questions related to the severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.It has been widely used and validated in several languages the world over.
EORTC QLQ [Quality of life Questionaries ] is an integrated system for assessing quality of life [health related ]. This self administered questionnaires incorporates five functional scales, physical [PF], role [RF], cognitive [CF], emotional [ef], and social; three symptoms scale for fatigue, pain and nausea/vomiting; a global health quality of life scale and several single items for financial impact and additional symptoms like diarrhea, appetite loss, sleep disturbance. This would help identify the quality of life of the participants and its affection.
If a participant cannot follow up at the said intervals, the pain scores would be obtained telephonically and the BPI, EORTC QLQ 30 form in prepaid envelopes would be given to them at discharge which they would have to duly fill in and post them to the given address at the appropriate intervals. If the next follow up to the hospital coincides with the 4th or 6th postoperative month, the participant will visit the pain clinic for an assessment and completing the BPI.
তারিখ
সর্বশেষ যাচাই করা হয়েছে: | 08/31/2019 |
প্রথম জমা দেওয়া: | 02/09/2017 |
আনুমানিক তালিকাভুক্তি জমা দেওয়া হয়েছে: | 02/24/2017 |
প্রথম পোস্ট: | 02/28/2017 |
সর্বশেষ আপডেট জমা দেওয়া হয়েছে: | 09/09/2019 |
সর্বশেষ আপডেট পোস্ট: | 09/10/2019 |
আসল অধ্যয়ন শুরুর তারিখ: | 03/05/2017 |
আনুমানিক প্রাথমিক সমাপ্তির তারিখ: | 03/05/2018 |
আনুমানিক অধ্যয়ন সমাপ্তির তারিখ: | 09/05/2018 |
অবস্থা বা রোগ
হস্তক্ষেপ / চিকিত্সা
Other: Non interventional study
পর্যায়
যোগ্যতার মানদণ্ড
বয়স অধ্যয়নের জন্য যোগ্য | 18 Years প্রতি 18 Years |
লিঙ্গ অধ্যয়নের জন্য যোগ্য | Female |
নমুনা পদ্ধতি | Non-Probability Sample |
স্বাস্থ্যকর স্বেচ্ছাসেবীদের গ্রহণ করে | হ্যাঁ |
নির্ণায়ক | Inclusion Criteria: - Female patient undergoing mastectomy simple radical with or without axilla dissection - Literate and can read and write in either English, Hindi, Marathi - Willing to fill forms and post them and/or answer questions on phone Exclusion Criteria: - Refusal of consent - Patient who has previously undergone major surgery around breast and chest wall - Benign breast pathology - Patient's with impaired cognitive function - Emergency surgery - PECs block study (PECTORALIS BLOCK) |
ফলাফল
প্রাথমিক ফলাফল ব্যবস্থা
1. Incidence of Post mastectomy pain syndrome (PMPS) [6 months after surgery]
মাধ্যমিক ফলাফলের ব্যবস্থা
1. pain severity [At 1 month after surgery]
2. pain severity [At 4 months after surgery]
3. pain severity [At 6 months after surgery]
4. Impact on daily function [At 1 month after surgery]
5. Impact on quality of life [At 1 month after surgery]
6. Impact on daily function [At 4 months after surgery]
7. Impact on quality of life [At 4 months after surgery]
8. Impact on daily function [At 6 months after surgery]
9. Impact on quality of life [At 6 months after surgery]