Introduction:

Postmastectomy breast reconstruction has become an increasingly important component of breast cancer treatment.[1]

Breast reconstruction is a valuable adjunct to the treatment for breast cancer. Deep inferior epigastric perforator flap can be used for breast reconstruction where in skin, fat and blood vessels are cut from the wall of lower abdomen and moved up to chest to rebuild breast and micro anastomosis done.

Multiple small sensory nerves may be injured during breast surgery when breast tissue is surgically removed from the chest, sensory nerves travelling through these tissues are transacted, stretched or caught up in scar during healing process.

Nerves innervating the rectus abdominis are at risk during DIEP flap harvest. For the majority of patients, acute postoperative pain following breast reconstruction is an expected surgical outcome that readily resolves with time and acute pain intervention. However, patients who suffer poorly controlled postoperative pain understandably report less satisfaction with their surgical experience.[1]

Adequate control of postoperative pain directly improves patient satisfaction and outcomes.[2]

In addition, undermanaged acute postsurgical pain can lead to greater postoperative clinical morbidity and higher hospital costs. For a surprising and unfortunate number of patients, acute postoperative pain persists beyond the normal course of postsurgical recovery, and more severe postoperative pain is established as a robust risk factor for the development of potentially debilitating chronic pain.[1]

We therefore propose to assess the pain severity in these patients and type of pain and quality of life following DIEP surgery.

Chemotherapy and radiotherapy can be additional sources of pain and related symptoms.

Neuropathic pain is defined as pain caused by a primary lesion or dysfunction in nervous system [3]. It is often chronic and debilitating in nature, disrupting quality of life and posing huge morbidity and financial burden.[4]

AIMS AND OBJECTIVES

Primary Objective:

Pain severity on day 1,2,3, and 1month, 3 months after surgery.

Secondary Objective:

1.    Type of pain from pain descriptors and neuropathic pain questionnaire (Pain DETECT) at 1 month,3 months after surgery.

2.    Impact on quality of life before recruitment and 1 month,3 months after surgery.

INCLUSION CRITERIA

1.    All female patients undergoing breast reconstruction with DIEP flap.

2.    Patients giving consent preoperatively and willing to be contacted telephonically for pain related information.

3.    Patients willing to post the quality of life questionnaires at appropriate intervals.

EXCLUSION CRITERIA

1.          Refusal of consent.

2.          DIEP done following failure of first reconstruction.

STUDY METHODOLOGY

This is a prospective, observational study over a period of 1 year with follow up for 3 months.

After IEC approval, all patients undergoing breast surgery with DIEP flap reconstruction would be enrolled in the study after obtaining informed consent preoperatively.

Details of the patient can be obtained from the patient files, Anesthesia records and electronic medical record.

Pain scores will be assessed using numerical rating scale (mild 1-3,moderate 4-6,greater than 7 severe).Pain scores both average and worst on post operative day 1,2,3 and thereafter 1,3 months can be recorded telephonically.

Patients with pain uncontrolled by regular analgesics prescribed by the surgical team would be referred for further input and management to acute pain service. Analgesics used will be noted both in the immediate postoperative period as well as at 1 month and 3 months from the date of surgery. Radiation therapy and chemotherapy details will be obtained from electronic medical record.

Type of pain from pain descriptors (stabbing, pricking, burning, numbness etc) and neuropathic pain questionnaire (Pain DETECT) at 1 month,3 months.

It is a self- reported questionnaire that is filled out by patients themselves. It consists of 9 items: 7 sensory symptom items, including burning, tingling, or prickling sensations, tactile and thermal allodynia, electric shock-like sensations, numbness, and pressure-evoked pain sensation, that are graded from 0 to 5 on a Likert-type scale indicating never to very strongly agree. 1 temporal item on pain course pattern graded from -1 to +1; and 1 spatial item on pain radiation graded from 0 for no radiation to +2 for radiating pain.

 The total score calculated from the 9 items ranges from -1 to 38, with higher scores indicating higher levels of NeP. [4]

Quality of life at the time of recruitment and 1 month,3 months after surgery can be assessed with the help of questionnaire given to the patients before discharge which has to be filled duly by the patients and post them at appropriate intervals,

The impact on quality of life will be assessed from the EORTC-QLQ 30 questionnaire that will be completed by the patient, participant will required approximately 20 to 30 minutes to complete the questionnaire.

Details of postoperative complication such as local infection, postoperative hematoma, venous congestion, flap necrosis will also be recorded.

Participant with uncontrolled pain by regular analgesics prescribed by the surgical team will be referred for further management to acute pain service and to chronic pain services or palliative medicine department if needed.

Sample Size

A convenient sampling technique will be used for enrollment and sample size calculation. All female patients undergoing breast reconstruction with DIEP flap over a period of 1 year starting immediately after IEC approval date with follow up for 3 months will be screen. We are expecting a 8 to 9 participant enrollment per month hence approximately 100 participants will be enrolled in the study. 

STATISTICAL ANALYSIS PLAN:

Pain severity will be assessed using numerical rating scale (mild 1-3, moderate 4-6, greater than 7 severe) and will be presented as counts and percentage on day 1, 2, 3, after 1 month,3 months after surgery. Type of pain from pain descriptors will be presented as counts and percentage with (95 % C.I.).

Neuropathic pain score will be calculate using scoring manual and presented as counts and percentage. Quality of life scoring will be done using QLQ-C30 scoring manual and presented as mean (sd). All analysis will be done using SPSS version 25.

BUDGET

No additional procedure would be performed on the patients, neither will the study add to the cost of the patient’s care. This study would not incur any additional cost on the patient or on TMH. Hence funding will not be required to carry out this study.

ETHICAL CONSIDERATIONS

This is a non-interventional study which does not alter the method of treatment or care offered to patient by any mean.