A STUDY TO COMPARE THE EFFECT OF TOPICAL ANESTHETIC CREAM AND CUTANEOUS STIMULATION ON AV FISTULA PUNCTURE RELATED PAIN AMONG PATIENTS UNDERGOING HAEMODIALYSIS IN DISTRICT HOSPITAL, TUMKUR.
PROFORMA FOR THE REGISTRATION OF SUBJECT FOR DISSERTATION
SUBMITTED BY
MACDEEN DAVID
MEDICAL SURGICAL NURSING
2012 – 2014
AKSHAYA COLLEGE OF NURSING, IIND CROSS,
ASHOKA NAGAR, TUMKUR.
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE, KARNATAKA
PROFORMA FOR THE REGISTRATION OF SUBJECT FOR DISSERTATION
1 / NAME OF THE CANDIDATE AND ADDRESS / : / Ms. MACDEEN DAVID1 YEAR M Sc NURSING
AKSHAYA COLLEGE OF NURSING, TUMKUR.
2. / NAME OF THE INSTITUTION / : / AKSHAYA COLLEGE OF NURSING
3. / COURSE OF STUDY AND SUBJECT / : / 1 YEAR M Sc NURSING
MEDICAL SURGICAL NURSING
4. / DATE OF ADMISSION / : / 15-06-2012
5. / TITLE OF THE TOPIC / : / A STUDY TO COMPARE THE EFFECT OF TOPICAL ANESTHETIC CREAM AND CUTANEOUS STIMULATION ON AV FISTULA PUNCTURE RELATED PAIN AMONG PATIENTS UNDERGOING HAEMODIALYSIS IN DISTRICT HOSPITAL, TUMKUR.
6. BRIEF RESUME OF THE INTENDED WORK
INTRODUCTION
The kidneys are vital organs which perform an incredibly wide array of functions for the body, most of which are essential for life. Some renal functions have obvious logical and necessary connections to each other. Others seem to be totally independent1. The kidney of humans contains roughly one million nephrons. This number is already established during prenatal development; after birth, new nephrons cannot be developed, and lost nephrons cannot be replaced.
Kidney diseases are occurring due to variety of reasons. Chronic Kidney Disease (CKD) is a progression from health to illness which results in a permanent failure of the excretory,regulatory and hormonal (metabolic) functions of the kidney. CKD can be a slowly progressive disease over many months or years, which results from the gradual loss of nephrons. The function may be stable for prolonged periods of time and can be managed with conservative management strategies. CKD is often asymptomatic in the early stages and is often not diagnosed until sufficient impairment exists to retain uremic toxins in the blood. Unfortunately the damage caused by CKD is irreversible, unless the patient is managed appropriately, particularly at the early stages, it can then be impossible to delay or even stop their CKD progressing to laterstages of established renal failure where the person will require Renal Replacement Therapy (RRT) of some form to maintain life.1
Chronic kidney disease (CKD) is defined as kidney damage or glomerular filtration rate (GFR) below 60 ml/min per 1.73 m2 for 3 months or more irrespective of the cause. The Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines have classified CKD into five stages.
The number of patients with chronic kidney disease (CKD), and the subsequent need for renal replacement therapy (RRT), has reached epidemic proportion and is anticipated to rise further. CKD affects approximately 10% of the population worldwide and it is estimated that over 1.1 million patients, with end stage renal disease (ESRD) currently require maintenance dialysis is increasing at a rate of 7% per year. If the trend continues, by 2010 the number will exceed 2 million. This figure excludes third world countries, where there is less availability of, and access to dialysis services, so there is an underestimate of the true demand. In United Kingdom the incidence of ESRD has doubled over the last ten years and has now reached 101patients per million of population (pmp). This is below the European and United States of America averages of approximately 135 and 336 pmp respectively. Studies such as the NHANES (National Health and Nutrition Examination Survey) which provided data on the adult unselected population estimated that 4.7% of US adults had CKD stage 3 or higher (defined as estimated glomerular filtration rate (eGFR) <60ml/min/1.73m2). They also estimated that up to 11% of the general population (19.2 million) has some degree of CKD.2
World Health Organization estimates that the diseases of the kidney and urinary tract contribute to over 850000 deaths and over 15 million disability-adjusted life years 10. In United States (US) alone, over 30 million people have been diagnosed to have CKD and it is estimated that over 6, 00,000 will need renal replacement therapy by 2010, costing US dollar 28 billion.11 It is estimated that approximately one lakh new patients develop ESRD in India annually. This suggests the possibility that the burden of CKD could be significant in India.3
Considering the growing number of clients afflicted with CKD, the option to prolong the life is limited to Renal Replacement Therapy (RRT) which includes dialysis and kidney transplant. The Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines recommend that patients with chronic kidney disease (CKD) who reach an estimated glomerular filtration rate (GFR) of 15–30 mL/min/ 1.73 m2 (i.e. stage 4) need to be prepared for kidney replacement therapy.4
Clinically, dialysis is a technique in which substances move from the blood through a semi permeable membrane and into a dialysis solution (dialysate). It is used to correct fluid and electrolyte imbalances and to remove waste products in renal failure. The two methods of dialysis available are peritoneal. 4
Functional vascular access is needed for all extracorporeal dialytic therapies dialysis and haemodialysis (HD). vascular access remains as the lifeline for patients with end stage renal disease who need chronic intermittent haemodialysis (HD) therapy. The ideal HD access should have a long length of a suitable superficial vein for cannulation in two places more than 5 cm apart with a sufficient blood flow for effective dialysis, usually in excess of 400 ml/min. A vascular access should have good primary patency, have a low risk of complications and side effects, and leave opportunities for further procedures in the event of failure. Ideally, a first access should be an Arterio Venous (AV) fistula placed peripherally at the wrist. However,upper arm and lower limb access sites are increasingly used because the aging dialysis population, with multiple co morbidities, has poor and diseased arm vessels that may be unsuitable for the creation of a simple wrist fistula.
In the clinical set up intravenous injection is taken with needle of 22 gaugeimposes significant pain. For many patients the mere mention of the need for insertion of an intravenous catheter invokes anxiety and dread. These emotions may become exaggerated at times, triggering a vasovagal reaction. This reaction can resultin syncope, unresponsiveness, hypotension, and diaphoresis. Patient's anxieties andfears concerning needles are real and may even prevent them from seeking healthcare. Haemodialysis through AV fistula uses 14-16 gauge needles in whichpatient has to suffer much pain with AV fistula puncture pain than with intravenousinjection.5
6.1 NEED FOR THE STUDY
In India the projected number of deaths due to chronic diseases will rise from 3.78 million in 1990 (40.4% of all deaths) to an expected 7.63 million in 2020 (66.7% of all deaths). Traditionally, health programs for prevention of chronic diseases have mainly focused on hypertension, diabetes mellitus and cardiovascular disease, however, the increase in the prevalence of chronic kidney disease (CKD) progressing 6to end-stage renal disease (ESRD) and the consequent financial burden of renalreplacement therapy (RRT). In both developed as well as developing nations hashighlighted the importance of CKD and its risk factors. The CKD burden is increasingrapidly worldwide. At the end of 2004, 1,783,000 patients worldwide were receivingtreatment for ESRD, of which 77% were on dialysis and 23% had a functioning renaltransplant (RT), and this number is increasing at a rate of 7% every year. If the currentsituation prevails, the global ESRD population will exceed 2 million by the year2010. The average incidence of ESRD in developing countries is 150 per millionpopulations (pmp), which is lower than what is reported in the developed world.
All patients diagnosed as ESRD needed RRT. In developing countries such as India, the management of end-stage renal disease (ESRD) is largely guided by economic considerations. Haemodialysis (HD) is mainly a short-term measure to support ESRD patients prior to transplant. The cost of peritoneal dialysis (PD) is two times higher than that of HD, fewer than 2% of patients are started on PD. Among the three RRT options available, renal transplant is the preferred mode, as it is most costeffective and provides a better quality of life. But due to financial constraints and nonavailability of organs, only about 5% of ESRD patients undergo transplant surgery. Though the removal of organs from brain-dead patients has been legalized, the concept of donation of organs from deceased donors has not received adequate social sanction. Only 2% of all transplants are performed from deceased donors.6
Haemodialysis is not possible without vascular access. In case of patient undergoing maintenance haemodialysis needed permanent vascular access, no vascular access has exceeded the success and reliability of Arterio Venous Fistula (AVF). Fistulas have the best overall patency rates and least number of complications (e.g., thrombosis, infections) of all vascular accesses. To draw the blood from fistula AVF needles are used. The needles used are 14 to 16 gauges and are inserted into the fistula or graft to obtain vascular access. One needle is placed to pull blood from the circulation to the HD machine, and the other needle is used to return the dialyzed blood to the patient. The needles are attached via tubing to dialysis lines. The insertion of large bore needle in to AV fistula causes significant pain.
Application of topical anaesthetic cream is non invasive pharmacological measures of pain management. A study conducted in 2001 to detect the minimal application time of Eutetectic Mixture of Local Anaesthetic (EMLA). This study was conducted in middle Tennese State University to determine the effects of 5 minute application of EMLA cream would have on a patient’s perception of cannulation. This study compared pain perception between an experimental group who received EMLA cream and a control group who received placebo. Sample consisted of 40 males and females who underwent ophthalmic surgical procedures. There were 20 subjects in each group when pain was investigated all patient reported some level of pain following cannulation. There was a significant difference between the two groups .The findings of this study suggests that a 5 minute application of EMLA cream is adequate to decrease pain associated with intravenous cannulation.7
Cutaneous stimulation is non invasive non pharmacological measure of pain management by superficial heating or cooling of skin. These pain management methods include cold packs and hot packs and should be used in conjunction with exercise.
A comparative study was conducted to determine the effects of two non – pharmacologic pain management methods for intramuscular injection pain in children. Ninety samples were chosen randomly and were divided into groups, the first group received distraction and second group received cold therapy and the third group received routine care. Oucher scale was used to measure the pain intensity .Average pain intensity in local cold therapy, distraction and control group was 26.3, 34.3 and83.3 respectively. The finding of the study shows that cold therapy has significanteffect on pain reduction.
Investigator during his clinical experience in dialysis unit observed that patients undergoing haemodialysis through AV fistula reported severe pain during AV fistula puncture. Local anaesthetic injection at the puncture site can be used to reduce the pain but patients are not willing to take local anaesthetic because it also causes significant pain while puncturing. Further it causes bruising sensation and vaso constriction. Oral analgesics are another alternative, but many of them are Non Steroidal Anti Inflammatory Drugs (NSAIDs) which are nephrotoxins. So for these patients non invasive methods of pain relief are most useful. Cutaneous stimulation and topical anaesthetic cream are non invasive pain relief measures, which has an effect on AV fistula puncture related pain. So study to compare the effect of topical anaesthetic cream and cutaneous stimulation on AV fistula puncture related pain will be helpful to identify the better option.8
6.2 REVIEW OF LITERATURE
Review of literature is a key step in the research process. A review of literatureis comprehensive and covers all relevant research and supporting documents in print.Literature review is essential to locate similar or related studies that have already beencompleted which helped the investigator to develop deeper insight into the problem andgain information on earlier studies. Review of literature is a systematic identification,location, scrutiny and summary of written materials that contain information on researchand the problem.
The literature reviewed related to the present study is and presented under the followingheadings
AV fistula as a vascular access in haemodialysis
AV fistula Puncture related pain in haemodialysis
Effect of topical anaesthetic agent in reduction of pain
Effect of Cutaneous stimulation in reduction of pain
AV fistula as a vascular access in haemodialysis
Haemodialysis is a life saving treatment for patient with chronic kidney disease. Before beginning haemodialysis treatment, a person needs an access to their bloodstream, called vascular access. The access allows the patient’s blood to and from the dialysis machine at a large volume and high speed, so that toxins waste and fluid can be removed. The two most common vascular accesses are AV fistula and AV grafts (AVGs).
A retrospective study was conducted in Seoul, Korea to compare the efficacy of AVF, AVG, Fore Arm Basilica Vein Transposition (FBVT) AVF . The study was conducted among 389 patients (300 radial-cephalic AVFs and 89 brachial-cephalic AVFs). Of those, the cephalic AVFs were superior in primary patency when compared with the FBVT. The study findings reveal that all AVFs were superior to the AVG in patency, function and complications. Patency was also affected by age and the presence of previous access.The investigator point out that there were no infectious complications in the AVF; however, seroma/hematoma developed. In comparison withAVG, FBVTs showed significantly fewer thrombosis and infection (p < .001) The disadvantages of the AVF include a longer surgical procedure, longer time to maturation, possible vein damage, and wound problems in comparison with the AVG creation. The rationale for FBVT in reference to the AVG are patency rates, which were comparable to that of AVG, infectious complication is less in FBVT than AVG, the use of the basilic vein in an AVF may contribute to the development of the upper arm basilic vein, which would then be utilized for AVF when the FBVT fails, aforearm AVG can be the next option without sacrificing the vessels that could be used for AVF.9
A prospective randomized hospital based study conducted among 73 Chronic hemodialysing patients (48 males and 25 females) in Gezira Hospital For Renal Disease And Surgery, Saudi Arabia from January to July 2007 revealed that the man age of patient was 43.9 (ranging from 18 to 72). Seventy one (97.3%) of the patients had been dialysed before creation of AVF and 67 (91.8%) of the study subjects 18 undergone with temporary access. All patients (n=73) had a native AVF as a permanent vascular access. A primary radio-cephalic AVF was created in 78.1 % of patients, cubital fossa in 20.5%; one case had left snuff AVF (1.4%). Percentage of AVF maturation reported in 67.1% of the cases within the first six week and 9.6 % of the cases AVF never matured. Failure rate of AVF occurred in only 26% cases, due to thrombosis in 20.5 %( n=15) and aneurysm in 5.5% of the cases.10
Dual Sil Kim, Sung Wan Kim et al conducted a comparative study to evaluate the vascular patency rates and incidence of interventions in autogenous arteriovenous fistulas and grafts. A total of 166 vascular access operations were performed in 153 patients between December 2002 and November 2009 were selected as the participants. Thirty seven cases were excluded due to primary access failure and loss of follow-up. One group of 92 autogenous arterioveous fistulas and the other group of 37 arteriovenous prosthetic grafts were evaluated retrospectively. Primary and secondary patency rates were estimated using the Kaplan-Meier method. Study results showed that primary patency rate (84%, 67%, 51% vs. 51%, 22%, 9% at 1, 3, 5 year; p=0.0000) and secondary patency rate (96%, 88%, 68% vs. 88%, 65%, 16% at 1. 3, 5 year; p=0.0009) were better in autogenous fistula group than prosthetic graft group. Interventions to maintain secondary patency were required in 23% of the autogenous fistula group (average 0.06 procedures/patient/year) and 65% of prosthetic graft group (average 0.21 procedures/patient/year). So the autogenous fistula group had fewer intervention rate than prosthetic graft group (p=0.01). The risk factor of primary patency was diabetus combined with ischemic heart disease and the secondary patency’s risk factor was age. Autogenous arteriovenous fistulas showed better performance compared to prosthetic grafts in terms of primary & secondary patency and incidence of interventions.11
Coburn MC and Carney WI Jr conducted a study to compare patency and complication rates between basilic vein and polytetrafluoroethylene (PTFE) for brachial arteriovenous fistulas (AVF) for long-term haemodialysis. All basilic vein and PTFE brachial AVF constructed between March 1988 and April 1993 were retrospectively reviewed. After construction of life-tables, log-rank testing was used to compare the primary patency rate of basilic vein AVF (n = 59) with the primary and secondary patency rates of PTFE AVF (n = 47). Complication rates were calculated for each type of fistula and compared by use of chi-squared testing. The result finding shows that primary patency rate for basilic vein AVF (90%) was superior to that of PTFE AVF (70%) at 1 year (p < 0.01), and at 2 years (86% vs. 49%, p < 0.001). Complications occurred two and a half times more frequently in the PTFE group than in the basilic vein group (p < 0.05). Basilic vein AVF provided superior patency rates and lower complication rates compared with PTFE AVF.12