Jurnal Keperawatan Medikal Bedah

JURNAL KEPERAWATAN MEDIKAL BEDAH POSTSURGICAL PAIN OUTCOME OF VERTICAL AND TRANSVERSE ABDOMINAL INCISION : DESIGN OF A RANDOMIZED CONTROLLED EQUIVALENCE TRIAL

OLEH: Rizal El Fata J230080036 PROGRAM PROFESI NERS FAKULTAS ILMU KESEHATAN UNIVERSITAS MUHAMMADIYAH SURAKARTA 2010

POSTSURGICAL PAIN OUTCOME OF VERTICAL AND TRANSVERSE ABDOMINAL INCISION : DESIGN OF A RANDOMIZED CONTROLLED EQUIVALENCE TRIAL ABSTRAK Background There are two ways to open the abdominal cavum in elective surgery: analyze the transversal slices and vertical slices. Various clinical studies and metaanalysis has revealed that analyze the transversal incision has advantages

compared to other sections when considering the complications that may occur. However, in a recent survey found 90% of all abdominal incision slicing up of visceral

still

using

vertical

slices.

Incompatibility

of

the

two

existing

recommendations, clinical research and clinical practice can explain the lack of acceptance of results of research on the deain research and analysis, also at the low internal validity, and therefore a minimum of external generalizability. Object of this research based on issues derived from the issue of patients' perceptions. Method Is the technique of random controls on intra-operative observation and experimentation with the patient blinded two-group parallel equivalent. Research carried out the Department of General, Visceral, Tauma and Outpatient Surgery at Medical School, University of Heidelberg. Total patients are men and women amounted to 172 people, aged from 18 years of planned elective abdominal surgery and who are qualified to do analyze the transversal or vertical slices. To demonstrate these two approaches, one or more superior in perception of the patient, and the first endpoint is defined: patients experience pain (VAS 0-100) on the second day after surgery with the same ).] mg / h [analgesic (piritramide The confidence interval on this approach will be used for analysis. = 0.05 and 0.8 The power produce each group numbered 86 people.αAssurance level The second endpoint: time interval to open and close the abdomen, the earliest occurrence of complications (frequency of opening the abdomen, post-operative pulmonary complications and wound infections) and the complications that arise later (the frequency of emergence insicional hernia). Different outcome variables will be ranked by patients and surgical operator to assess the relevance of possible endpoints from the perceptions of patients and carriers. Conclusion This study is a randomized konyrol observer and patient-blind trial with two parallel groups to answer the question whether tranverssal same abdominal incision with a vertical abdominal incision to describe the endpoint Background Choice of incision for open surgery of abdominal cavum can be based on the patient, operator, or the health care system criteria. From the points given patient to describe pain and restriction of the digestive tract is important. Considering

previous research, probably most were not examined with attention to systematic or pesien. Attention of most surgeons, in addition to speed and to establish new optimal for field operations, is: time to open and the frequency of opening the abdomen, wound infection, post-operative pulmonary complications, and hernia insicional. For the economy, the parameters used such as the duration of surgery, LOS, and physical and mental activity in question. Priority results from randomized studies and meta-analysis of field control has been suggested that pendekatam analyze the transversal is better than any other type of incision when considering the possibility of complications. But the practice of surgery with a midline incision is still a habit. One reason for this discrepancy may be due to lack of research and design, lack of internal validity. The main problem is lack of research that has the power (the sample is too small), to menestimasi differences properly, the lack of standardization of techniques and / or loss of abdominal cavum closure operations, without binding the patient and prejudice or estimated, the research that is not homogeneous in the metaanalysis, terstandarnya and less post operative analgesic and confectionery. One meta-analysis concluded that gained analyze the transversal incision is superior to the midline incision, the reduction of bruising on the early appearance of complications (opening of the abdominal and pulmonary disease) and late complications

(insicional

hernia)

associated

with

favorable

anatomy

and

physiology. However, the incidence of complications not only depends on the type of incision, but also on the opening technique. Research has been returned to the format including initial and re-tested separately according to their submitted the final point (population). Only one Random Controlling Trial (RCT) focused on the frequency of opening the abdomen and found no benefit from analyze the transversal approach. Terkaji early pulmonary complications in RCT and distributed in both groups with the same. In a review study showed no significant differences in the occurrence of wound infection. In the original data Greenal et al, the number of hernia insicional similar in the two approaches or slices. In short, retrospective and prospective data collected on a meta-analysis studies, can then be determined as of the results are not convincing. At present there is no evidence that analyze the transversal incision is superior to other types of insisis at the beginning and endpoint of late post-operative complications. Therefore, it can be ensured by focusing on patients' perceptions. To obtain valid research, observation and patient blinded randomized control study is a standard requirement for opening technique, pain therapy, and

postoperative treatment. This study intends to show no significant difference in pain intensity as felt by the client where to get piritramide with the same demands between two abdominal insicion, with the assumption that similar complications have estimated the same. Just the beginning and end of the complications of the surgery will be reviewed as a follow up to 1 year. Method Object The primary object of this study is to analyze the transversal and vertical slices membandingakan in abdominal surgery with mempertimbangakan intensity of the experience of having experienced abdominal pain and needs of the patients used analgesics is the habit of operating procedures. The main endpoint was the intensity of the experience of having experienced abdominal pain patients, measured by Visual Analogue Scale (VAS) and obtain the same analgesic (piritramide mg / H) on the second day post surgery. The secondary object is the frequency of early and late onset complications such as inflammation of the stomach, post operative complications in the lungs, wound infection and hernia insicional (Table 1). Additionally, pain is measured on a scale Greissner pain sensation, pain kuisiner as modified by Mc. Gill, design research conducted in Germany. To assess the relevance of the endpoints of client perception and the perception of the surgeon, followed by rank 1 (most important) to 9 (least important) from the client and surgeon, post operative complications, post operative kelwmahan, improvements in maximum physical or excited, and cosmetic results. First surgeon rank them before surgery. Rank them from the aspect of patient 2 times: 1. At inclusion and then on the termination of observations, whether there are changes during their treatment. Design research An observation of intra-operation with the control and patient blinded randomized trial with mempertimbangakan accuracy. The same parallel group design has been selected for it, the basis and priorities of education and knowledge, the large difference can not be expected. Randomization distratikasi operation plan based on those records. Place

Research carried out the Department of General, Visceral, Trauma Surgery and Outpatient at the University of Heidelberg Medical School. Participant Total patients are men and women amounted to 172 people, aged over 18 years planned for elective abdominal surgery and who are qualified to do analyze the transversal or vertical slices. Criteria requirements Inclusion criteria: Age more than 18 years, life expectancy more than 12 years, procedures to be followed by the patient's plan:

1. Whipple Procedure / Pylorus-Preserve classic 2. Resection of the duodenum-Preserve in pancreatic head, 3. Partial / total gastrektomy 4. Colon resection (left / right / analyze the transversal) 5. Ileocecal resection (primary or elective surgery, patients should be given informed consent, the patient had given informed consent) Exclusive criteria:

1. Permanent therapy with opioid drugs for some reason during the 12 months before the operation (duration longer than 2 weeks) 2. Incompatibiliti metamizole 3. Recurrent

abdominal

surgery

(Appendiktomi

without

laparakospik,

Laparoscopic

cholecystectomy, Laparoscopic adrenalectomy, diagnostic laparoscopy or appendiktomy), including Scdan fannenstiel incici (histerektomy) 4. Participation from other yabg intervention trial that will affect the intervention and the results of this study 5. Some psychiatric or neurological disease 6. Lack of symptoms 7. Drug and alcohol abuse 8. Immunosupresif therapy recurrent (> 40 mg corticosteroids / day or azathioprine) 9. Chemotherapy within 2 weeks before surgery 10. Abdominal radiotherapy komplete> 8 weeks before surgery (except for neoadjuvant therapy, for example: pancreatic Ca) 11. Surgical liver, gallbladder, spleen and rectum)

Ethics, Informed Consent The last procedure is approved by independent ethics committee Hedelberg University Medical School. Informed consent will be obtained from the patient either orally maqupun written before entering the study. Security Abdominal trauma, lung infection, and wound infection is a secondary end point, but also defined as adverse events (events are less well). Abdominal trauma and post operative infections will always dipertimbngakan as adverse events. Limitation of adverse events include a few signs, symptoms, and syndrome, or diseases that appear or worsen during periods of observation in patients in clinical research and all that may damage the health of patients. Limitation of adverse events also include the findings or results of laboratory and other diagnostic procedures that dipertimbangakan relevant. erious adverse events are adverse events that occurred during the observation period

resulting

in

death,

acute

life

threatening,

requires

or

prolong

hospitalization, or the consequences of the inability of the sugnifikan and incompetence. Security-related data will be analyzed in the frequency seseuai:

1. Adverse events and serious adverse events are stratified according to organ system. 2. Adverse events are stratified according to severity 3. Adverse events are stratified according to cause Statistical analysis Alternative hypothesis of a primary endpoint is the remedy there is no relevant difference in pain postoperasi. Pain postoperasi have 2 essential components: the experience of pain patients who were measured on days 2 postoperasi with VAS and a programmed number of analgesic drugs. After that, two tests must be analyzed konfirmative equivalence. In the second test interval approach will digunakan.Level significant konfidence be 0.05. Bonferrone-Holm procedure will be used to analyze this multiple test problem. Since the randomization will be grouped by classes of operations, the analysis should also be grouped. Then, an analysis of variance with 2 factors incision type and operation

classes will be displayed. Substitution of a superiority design is planned if one of these equivalence test does not give significant results. The analysis will be shown on basic population (ITT) and conform with the principles of ITT. A patient who entered the ITT population after the incision. Primary endpoints will also be analyzed on a basic population "perprotokol". Deskriptive method will be used to assess data quality, homogeneity tretment group, endpoint security and analyze the transversal approach vs. vertical Sample Size Calculations of sample didasrkan at α = 0.025 (Bonferroni-Holm) and the desired power 0.80. Calculations were done separately in each primary variable using Query advisor version 4.0, Statistical Solutions Ltd.., Cork, Ireland. The maximum value of the sample size calculation should be taken as the sample size. The result was 86 patients per group (see below). Painful experience

1. Design equivalence: Assume there is no difference between group means, SD 20 (VAS), and the equivalence margin δ = 10 (VAS), 86 patients each group desired. 2. Design superority: Assuming a minimal clinically relevant difference is ∆= 10 (VAS) between the group means and SD was 20 (VAS), 78 patients each group desired. Total Piritrimide

1. Design equivalence: Assume there is no difference between group means, SD 1 = 1 (mg / h), 23 patients each δ (mg / H), and an equivalence margins group desired. 2. Design = 1∆superiority: It is assumed clinically relevant difference minima (mg / h) between the group mean and SD 1 (mg / h), 21 patients each group requested. To reach the 86 patients in group 1, approximately 300 patients continued to be based on data skreening RS 2000 we conducted randomization of 15 patients per month. 12 months, until October 2004.± To reach the number of samples, the registration will expireThe next time was 1 year. Patients who are not included, not randomly, or not followed / follow-up will be documented and questioned specifically for the recall of a research study, according to a statement CONSURT. Randomization Randomization list will be generalized to all strata of the computer (SAS Version 8.2, SAS Institute Inc., Cary, USA). List randomisassi already disegek (stamp duty) will be submitted to the investigative file. Patients were randomized using sealed envelopes when

entering the operating room after abdominal surgery are prepared. Blinding After surgery in the operating room the entire abdomen will be closed with a bandage to cover the wound incision lua. Wound dressings will be opened 1 times post-op after the "primary endpoint" which is a blinded study nurse olh at day 2 post-surgery. If you need to bandage will be opened before the day-to-2 postoperasi and will be done by unblinded staff not involved during parcobaan.

Program management Elektrocauterisasi will be used for all patients as the standard skin incisi. In patients who were randomly separated to approach the median of the median line. In group incisi tranvese, muscle also dincisi by cauterisasi rectum. Incisi first time between the time of placement on the skin and towing will be dropped in both groups. The abdominal wall is closed in the same way (standardized) in both groups: Four Mikulic Clamps are placed on the edge of the facia abdominal and cutaneous, with two mono penutpannya techniques plus loups (BBD Aesculup, Tuttlingen, Germany), both of which ended in incisi with comparison / ratio 4:1 (suture, scar length), no cover or drainage subkutaneus subkutaneus which included skin is closed with skin clips. Skar length measured in cm. Wound dressings are placed in such a way that closes all of the abdomen, including abdominal drainage. For pain management plan has been defined (standardized) by metamizole (Novalgin, Aventis Pharma), 1 g given daily by IV perinfus 4X. If the patient has a bad reaction / abnormal, then given paracetamol (perfalgan, upsamedica EmbH) 1 g per day by IV IV 4X perinfus). Patients will not be excluded from the trial if the drug is replaced. Monitoring In an independent study, nurses were not involved in the trial or CRF (Case Report Form) are complete will monitor the patient. Surgical Monitoring can ensure that the surgical procedure that has been standardized already done correctly, and will be conducted by an independent surgeon, and not involved in the trial Follow-up Passien postoperasi observed during 30 days, to determine early onset of complications as a secondary endpoint. Follow up will be complete at 1 year after surgery by performing a physical examination, including ultrasound to mengeksklusi incisi hernia. Conclusion

TRIAL POVATI incisi comparing 2 types of general surgery. Perangkingan qualitatively performed by patients and surgeons to assess the relevance of whether the primary endpoint could be included or not. The main plan in the design of this study are: 1. Perspectives of patients as the primary endpoint 2. Detailed calculations on the sample size adekuat 3. Randomization was stratified for planned surgical procedures 4. Assessment of the patient and observer blinded to the primary endpoint Nursing IMPLICATIONS:

1. Nursing tasks on post-operative phase is to treat patients with post operative wound in this case is incisi in the abdominal wound. Proper wound care is intended to: a. Protect the wound and mechanical trauma b. Immobilize wounds c. Absorb drainage d. Prevent contamination and impurities of the body (feces, urine) e. Helping homeostasis f. Inhibit or kill microorganisms g. Provide the appropriate physiological environment for wound healing Providing

security

for

the

client's

mental

and

physical

Wound care and supervision against the possibility of post operative complications in cases with abdominal incisi both transverse and vertical not differentiated 2. Nursing duties no less important in managing patients with post operative pain is the handling of post operative problems. There are several theories of pain management that can be applied by nurses, namely: a. Non-pharmacological Using pain assessment system in komprehensive: location, characteristics, onset /

duration,

frequency,

quality

and

the

factors

of

precipitation.

Observe non-verbal signs that indicated the client associated with discomfort, especially if the client is not able to communicate discomfort. Using therapeutic communication strategies to explore the experience of pain and show the client's acceptance of pain response Detection of the disturbances caused by the experience of pain experienced by clients, such as sleep patterns, relationships / communication with other people, mood / feeling.

Help clients and

families

to

provide

a

support

system

Create a supportive environment for clients to rest / sleep (quiet environment, not many visitors) Provide clear information about pain, such as the cause of pain, how long the pain will end, and how to anticipate the discomfort caused by painful episodes Control of environmental factors that may affect the response of clients that can cause pain / discomfort b. Pharmacology Collaborate with the medical team for the administration of anti-pain medications / analgesics according to the condition of the client, if necessary. References 1. Linden W, Stossel C, Maurice J. Psychosocial interventions for patients with coronary artery disease. A meta-analysis. Arch Intern Med 1996;156:745–52.[Abstract] 2. Keller M, Jadack R, Mims R. Perceived stressors and coping response in persons with recurrent genital herpes. Research in Nursing and Health 1991;14:421–30.[Medline] 3. Drob S, Bernard H. Two models of brief group psychotherapy for herpes sufferers. Group 1986;9:133–44. 4. Goldman CR. Toward a definition of psychoeducation. Hospital and Community Psychiatry 1988;39:666–8.[Medline] 5. Steiner JL, Lussier RG, Maust GC, et al. Psychoeducation about sexual issues in an acute treatment setting. Hospital and Community Psychiatry 1994;45:380–1.[Medline]