Incidence, type and severity of Pain with Quality of Life following Deep Inferior Epigastric Perforator (DIEP) Flap Surgery

Introduction:

Postmastectomybreast reconstruction has become an increasingly important component of breastcancer treatment.[1]

Breastreconstruction is a valuable adjunct to the treatment for breast cancer. Deepinferior epigastric perforator flap can be used for breast reconstruction wherein skin, fat and blood vessels are cut from the wall of lower abdomen and movedup to chest to rebuild breast and micro anastomosis done.

Multiple smallsensory nerves may be injured during breast surgery when breast tissue issurgically removed from the chest, sensory nerves travelling through thesetissues are transacted, stretched or caught up in scar during healing process.

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

Adequatecontrol of postoperative pain directly improves patient satisfaction andoutcomes.[2]

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

We therefore propose toassess the pain severity in these patients and type of pain and quality of lifefollowing DIEP surgery.

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

Neuropathicpain is defined as pain caused by a primary lesion or dysfunction in nervoussystem [3]. It is often chronic and debilitating in nature, disrupting qualityof life and posing huge morbidity and financial burden.[4]

 AIMSAND OBJECTIVESPrimaryObjective:

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

  Secondary Objective:1.    Typeof pain frompain descriptors and neuropathic pain questionnaire (Pain DETECT) at 1 month,3months after surgery.

2.    Impact on qualityof life beforerecruitment and 1 month,3 monthsafter surgery.

 INCLUSION CRITERIA1.   Allfemale patients undergoing breast reconstruction with DIEP flap.

2.    Patients giving consentpreoperatively and willing to be contactedtelephonically for pain related information.

3.    Patients willingto post the quality of life questionnaires at appropriateintervals.

EXCLUSION CRITERIA1.         Refusalof consent.

2.         DIEPdone following failure of first reconstruction.

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

After IEC approval, allpatients undergoing breast surgery with DIEP flap reconstruction would beenrolled in the study after obtaining informed consent preoperatively.

Details of the patient canbe obtained from the patient files, Anesthesia records and electronic medicalrecord.

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

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

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

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

 The totalscore calculated from the 9 items ranges from -1 to 38, with higher scoresindicating higher levels of NeP. [4]

Quality oflife at the time of recruitment and 1 month,3 months after surgery can beassessed with the help of questionnaire given to the patients before dischargewhich has to be filled duly by the patients and post them at appropriateintervals,

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

 Details of postoperativecomplication such as local infection, postoperative hematoma, venouscongestion, flap necrosis will also be recorded.

Participant with uncontrolled pain by regularanalgesics prescribed by the surgical team will be referred for furthermanagement to acute pain service and to chronic pain services or palliativemedicine department if needed.

 Sample Size

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

 STATISTICALANALYSIS PLAN: Pain severitywill be assessed using numerical rating scale (mild 1-3, moderate 4-6, greaterthan 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 willbe presented as counts and percentage with (95 % C.I.).

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

 BUDGET

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

 ETHICAL CONSIDERATIONS This is anon-interventional study which does not alter the method of treatment or careoffered to patient by any mean.