RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,
KARNATAKA, BANGALORE.
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION.
1. / NAME OF THE CANDIDATEAND ADDRESS / DR. PRAVEEN CHANDRA.K
DEPARTMENT OF GENERAL SURGERY
B.L.D.E.A’s SHRI B.M.PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE. BIJAPUR- 586103
2 / NAME OF THE INSTITUTION / B.L.D.E.A’s SHRI B.M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE. BIJAPUR - 586103
KARNATAKA
3 / COURSE OF THE STUDY AND SUBJECT / (M. S.) GENERAL SURGERY
3 YEARS
4 / DATE OF ADMISSION TO COURSE / 31-MAY- 2007
5 / TITLE OF THE TOPIC / PROSPECTIVE RANDOMISED COMPARATIVE STUDY OF TENSION FREE MESH HERNIOPLASTY DONE UNDER LOCAL ANAESTHESIA VERSUS REGIONAL ANAESTHESIA.
6 / BRIEF RESUME OF THE INTENDED WORK
6.1 AIM OF THE STUDY
6.2 NEED FOR THE STUDY
6.3 OBJECTIVES OF THE STUDY
6.4 REVIEW OF LITERATURE / REFER APPENDIX I
REFER APPENDIX II
REFER APPENDIX III
REFER APPENDIX IV
7 / MATERIAL AND METHODS
7.1 SOURCE OF DATA
7.2METHOD OF COLLECTION OF DATA
7.3DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR
INTERVENTIONS TO BE
CONDUCTED ON PATIENTS
OR OTHER HUMANS OR
ANIMALS? IF SO, PLEASE
DESCRIBE BRIEFLY.
7.4HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION / REFER APPENDIX V
REFER APPENDIX V
REFER APPENDIX VI
CERTIFICATE ENCLOSED
8 / LIST OF REFERENCES / REFER APPENDIX VII
9 / INFORMED CONSENT FORM / REFER APPENDIX VIII
10 / SCHEME OF CASE TAKING / REFER APPENDIX IX
11 / SIGNATURE OF THE CANDIDATE
12 / REMARKS OF THE GUIDE
13 / NAME AND DESIGNATION
13.1)GUIDE
13.2) SIGNATURE
13.3)CO-GUIDE
13.4) SIGNATURE
13.5) HEAD OF DEPARTMENT
13.6) SIGNATURE / Dr. BALASAHEB BHIMRAO METAN
M.S. GENERAL SURGERY
PROF.OF SURGERY
DEPT. OF SURGERY
Dr.P.L.KARIHOLU
MS. FAIS (ONCO.)
HEAD OF THE DEPARTMENT
GENERAL SURGERY.
14 / 14.1 REMARKS OF THE
CHAIRMAN AND PRINCIPAL
14.2 SIGNATURE
APPENDIX – I
AIM OF THE STUDY :
To study the effectiveness of local anaesthesia in comparison to regional anaesthesia in repairing uncomplicated inguinal hernia by measuring post-operative pain and post operative complication.
APPENDIX – II
NEED FOR STUDY :
Inguinal hernias are the commonest of all hernias and adult inguinal herniorraphy accounts for 15% of operations in general subject.
Inguinal hernias are operated both as an out patient procedure and in the traditional way with the patient hospitalized and operated on elective basis. Although they can be discharge after a short period ( short stay surgery) or after complete recovery. This introduction of short stay surgery not only releases the hospital waiting lists but also represents economic advantage and has certain social benefits for patients. Local anaesthesia is economically sound and field block technique for hernia repair is within the capability of operating surgeon. Complication and post anesthetic care for local anaesthesia is negligible compared to traditional regional or general anaesthesia.With the introduction of day care surgery for inguinal hernia repair, the local anaesthesia has its role to reduce cost and duration of hospital observation. It is also found from various studies. So this work is designed to study that hernioplasty under local anaesthesia is an acceptable alternative toconventional hernioplasty using spinal anaesthesia.This study is also intended to know which is suitable best for the patients coming to our hospital (most of them are from low socio-economic group) and to study the safety & cost effectiveness in both patients and hospital point of view.
.
APPENDIX – III
OBJECTIVES OF THE STUDY :
1)To study feasibility of inguinal hernia repair using local anaesthesia when compared to regional anaesthesia for short stay surgery.
2)To study whether short stay surgery for inguinal hernia is suitable for the patients coming to our hospital.
3)To compare the post operative complications related to regional / general anaesthesia and local anaesthesia.
APPENDIX – IV
REVIEW OF LITERATURE :
1)Parviz . k , Amid , Alex . G . Shulman et al2 : From the Lichtenstein hernia institute , Los angeles , California . Introduced a simple 6 steps infiltration technique that results in satisfactory local anaesthesia and prolonged post-operative analgesia, requiring a maximum of 30-40 ml local anaesthetic solution. They have concluded that the preferred choice of anaesthesia for all reducible adult inguinal hernia repair is local.It is safe , simple , effective and economical , without post anaesthesia side effects.
2)Gianetto Ezio , Sonia Cuneo , Bruno Vitale et al3 . in their journal 2000 from Department of surgery , University of Genoa school of medicine , Italy. Described a 7 yrs experience with recurrent inguinal hernia repair performed mainly with tension free mesh or plug technique under local anaesthesia through the anterior approach .The above method seems to be a low cost surgical technique that can be safely and effectively used even in a teaching hospital for the treatment of majority of patients with recurrent groin hernia.
3)Kendell J , J.A.Wildsmith and I G Gray5 : Department of anaesthesia , nine wells hospital and medical school ,UK . 2000 studied computerized data base of operating theater activity and used it to estimate the cost of regional and general anaesthesia for inguinal hernia surgery. Data retrieved for each procedure included the anaesthetic technique and drugs used,the duration of anaesthesia, surgery and recovery.581 patients received general anaesthesia, 346 patients received central nerve block 24 combination of both and 29 received an inguinal field block with intravenous sedation.The median cost in 29 patients who received a field block with intravenous sedation for hernia repair was much lower than the cost of either the general anaesthesia or central nerve block.
4)Callesen Torben , Karsten Bech & Henrik Kehlet7 : Department of surgical gastroenterology , Denmark . 2001 Evaluated the feasibility and safety of unmonitored local anaesthesia for elective open inguinal hernia repair ,made a prospective consecutive data collection from 1000 operations on primary and recurrent hernias .They concluded inguinal hernia repair can be safely performed under unmonitored local anaesthesia with infrequent post operative morbidity and acceptable satisfaction .
5)Anderson F H , K Neilson & H Kehlet8 : Surgical clinic Charlottenlund , Surgical clinic Hvidovre , Denmark . Performed a double blind randomized study in 160 patients under going inguinal hernia mesh repair under local infiltration anaesthesia with or without additional illioinguinal blockade . Intraoperative pain and pain at 24 & 48 hours post operatively analgesic requirements were assessed. Combined illioinguinal blockade and local infiltration anaesthesia is recommended for groin hernia repair to reduce intraoperative pain.
APPENDIX – V
SOURCE OF DATA:
- Patients attending B.L.D.E.A’s Hospital OPD and those who are admitted to the hospital for uncomplicated Inguinal Hernia Repair.
METHOD OF COLLECTION DATA :
- Patients admitted with inguinal hernia in surgical wards , BLDEA”s Hospital , Bijapur. From October 2007 to May 2009.It will be a time bound study.
- A thorough history will be taken.
- A detailed clinical examination will be done.
- Patient will undergo necessary investigations (available at BLDEA”s Hospital).
- Surgical management based on clinical examinations and investigations.
- Based on the diagnosis, type of surgery will be decided.
- Patients with inguinal hernia repair done under local anaesthesia are given anaesthetic mixture of 2% xylocaine 15ml + 0.5% sensorcaine 15ml + 30ml of distilled water.
- Post-operative recovery will be accessed including complications like urinary retentions, postoperative pain, headache, seroma, haematoma, scrotal oedema , infection, time at ambulation, recurrence and duration hospital stay.
- Post-operative pain will be evaluated using visual analogue scale at 30,60 120 & 240 minutes.
- Further patients will be followedup in surgery OPD for 6 months.
- Final outcome will be evaluated.
INCLUSION CRITERIA :
All patients admitted and operated in surgical ward BLDEA”s Hospital, Bijapur with primary uncomplicated inguinal hernia on elective basis.
EXCLUSION CRITERIA :
1. Complicated and irreducible inguinal hernia.
2. Patients age less than 16 years.
3. Patients with medical illness like uncontrolled Diabetis mellitus,
Hypertension, COPD, Obesity, BPH and Cardio vascular complications
- Hypersensitivity anaesthetic drugs.
- Anxious and apprehensive patients.
RESEARCH HYPOTHESIS
Local anaesthesia is as effective as regional / general anaesthesia for inguinal hernia repair and also reduces post operative pain and immediate post operative complication and cost effectiveness to the patient .
SAMPLING :
Study period from : October 2007 to May 2009.
Incidence of hernia in population is 5% out of which 75% are inguinal hernia9. Allowable error is considered 15%. Formula used for calculation of sample size is
n =4pq/L2.
Using this formula sample size is n=60
Details of cases will be recorded including history, clinical examination, and investigations done. All patients will be operated for Lichtenstein’s tension free hernioplasty. Patients will be randomized either to control group (where regional anesthesia used)or study group (where local anaesthesia ) in the operating room by sealed envelop.
Following statistical tests will be used to compare the results.
i) Diagrammatic presentation.
ii) Mean S D
iii) Z test or chi square test ( if necessary)
APPENDIX – VI
Investigations required are standard protocol and do not involve any animal experiments.These investigations are required as routine for diagnosis and to test the sensitivity to the local anesthetic.
1)Routine blood and urine tests
2)RBS, Blood Urea, Serum Creatinine,Chest X-ray.(when age of patient is >35yrs or if
Necessary)
3)USG if required
4)Routine test dose of local anesthesia.
APPENDIX – VII
List of References :
- Abbu R: Ambulatory herniorraphy under local anaesthesia in acommunity hospital. American Journal of Surgery1978;26:353-356.
- Parviz . K , Amid, Alex.G Shulman &Irving. L Lichtenstein :Local anaesthesia for inguinal hernia repair step by step Procedure.Annals of surgery 1994;200(6):735-737.
- Gianetto Ezio, Sonia Cuneo, Bruno Vitale et al : Anteriortension free repair of recurrent inguinal hernia under localanaesthesia,A 7 yrs experience in a teaching hospital.Annals of surgery 2000;231(1):132-136.
- Murabito R, Vecchio R, Alongi G et al: Local anaesthesia in treatment of inguinal hernia. Chir ital 1999:51:501-505.
- Kendell J , J A W Wildsmith & I G Grey : Costing Anaestheticpractice an economic comparison of regional and generalanaesthesia for inguinal herniasurgery.Anaesthesia 2000;55:1106-1126.
- Sirgusa G ,Geraci G,Li Volsi F et al: The treatment of inguinalhernia in one day surgery protocol,our experience.Minerva Chir 2000;55:493-7.
- Callesen Torben, Karsten Bech & Herik Kehlet :One thousandconsecutive inguinal hernia repair under unmonitored localanaesthesia.. Anaesthesia Analgesia 2001;93:1373-1376.
- Anderson F.H, K.Neilson & H Kehlet : Combined illioinguinalblockade and l;ocal infiltration anaesthesia for groin hernia repair-a double blind randomized study.British Journal of anaesthesia 2005;94(4):520-523.
- Mark A Malangoni; Raymond J Gagliardi. Hernias. In; Courtney M T, editor. Sabiston Text book of surgery. Volume no. 2. 17th edition. Saunders :Elsevier; 2005.p.1199.
APPENDIX - VIII
Informed consent will be taken in the following way.
PROCEDURE:-
All the patients recruited for study will be clearly explained about the reason for study and for selecting them as subjects for the study.
They will be explained about risks, benefits and confidentiality of the study. They are allowed to make a free choice of their own for inclusion in the study.
They are also told about the necessity for follow-up and furnishing of additional information when required.
SAMPLE INFORMED CONSENT FORM
Title of the Project: PROSPECTIVE RANDOMISED COMPARITIVE STUDY OF
TENSION FREE MESH HERNIOPLASTY DONE UNDER
LOCAL ANAESTHESIA VERSUS REGIONAL
ANAESTHESIA
PRINCIPAL INVESTIGATOR: Dr. BALASAHEB.BHIMRAO METAN
M.S. GENERAL SURGERY
PROF.OF SURGERY
Ph no.(08352) 262770
P.G STUDENT : DR. PRAVEEN CHANDRA.K.
DEPT. OF GENERAL SURGERY
Ph no.(08352) 262770
PURPOSE OF RESEARCH :
I have been explained about the reason for doing this study and selecting me as a subject for this study. I have also been given free choice for either being included or not in the study.
This study is for effective post operative pain relief, reduce the anxiety or stress post operatively, reduce or minimize unnecessary injection administration for analgesia, to reduce hospital stay and to reduce cost/expenditure on drugs.
PROCEDURE :
I have been explained about the various presentations of Inguinal Hernia and their management. First I have to under go certain investigations like Blood,Urine investigations, USG if necessary to confirm the clinical diagnosis. Later treatment will be planned. I will also have to take a test dose of the local anesthetic drug, which will be given to me before the operation.
RISKS AND DISCOMFORTS:
I understand that I may experience some pain or discomfort which may be present post operatively inspite of giving local anesthetic at the site of incision, and i understand that analgesics will be given to me depending on the need.
Benefits:
I understand that my participation in the study will have no direct benefit to me other than potential benefit of treatment. The major potential benefit is to find out that giving pre incisional local anesthesia infiltration will reduce postoperative administration of analgesics, reduce cost and also duration of stay in the hospital.
CONFIDENTIALITY :
I understand that the medical information produced by this study will become a part of hospital records and will be subject to the confidentiality. Information of sensitive personal nature will not be part of the medical record, but will be stored in the investigations research file.
If the data are used for publication in the medical literature or for teaching purpose, no name will be used and other identifiers such as photographs will be used only with special written permission. I understand that I may see the photograph before giving the permission.
REQUEST FOR MORE INFORMATION :
I understand that I may ask more questions about the study at anytime, Dr. Praveen Chandra.K. at the department of surgery is available to answer my questions or concerns. I understand that I will be informed of any significant new findings discovered during the course of the study, which might influence my continued participation. A copy of this consent form will be given to me to keep for careful reading.
REFUSAL FOR WITHDRAWAL OF PARTICIPATION :
I understand that my participation is voluntary and that I may refuse to participate or may withdraw consent and discontinue participation in the study at any time without prejudice. I also understand that Dr. Praveen Chandra.K. may terminate my participation in the study after he has explained the reasons for doing so.
INJURY STATEMENT :
I understand that in the unlikely event of injury to me resulting directly from my participation in this study, if such injury were reported promptly, the appropriate treatment would be available to me. But, no further compensation would be provided by the hospital. I understand that by my agreements to participate in this study and not waiving any of my legal rights.
I have explained to ______the purpose of the research, the procedures required and the possible risks to the best of my ability.
______
Dr. Praveen Chandra.K. Date:
(Investigator)
STUDY SUBJECT CONSENT STATEMENT :
I confirm that Dr.Praveen Chandra.K. has explained to me the purpose of research, the study procedure, that I will undergo and the possible discomforts as well as benefits that I may experience in my own language. I have been explained all the above in detail in my own language and I understand the same. Therefore I agree to give consent to participate as a subject in this research project.
______
(Participant) Date
______
(Witness to signature)Date
SURGICAL PAIN SCALES
We want to know how much pain or discomfort you had within the last 24 hoursas a result of lumpectomy. Use a pen or pencil and draw an '.x" on the lines below to indicate the average amount of pain or discomfort you experienced. For instance, if you did not have much pain today you would draw an "x" down near the No Pain Sensation end of the line. If you had a lot of pain today, you would make an 'x" up towards the Most .Intense Pain Imaginable end of the scale.
I. What was the average amount of pain you had when you were at rest.?
010
No Pain Most Intense Pain Sensation Imaginable
2. How much pain did you have during your normal activities
(for example, walking, climbing stairs, getting up from a chair)
010
No Pain Most Intense Pain
Sensation Imaginable
3. How much pain did you have when you were exercising, lifting objects you used to be able to lift comfortably?
I have not done any of these activities today0 0 10
No Pain Most Intense Pain Sensation Imaginable
01
APPENDIX –IX
10) SCHEME OF CASE TAKING:
1) Name :CASE NO :
2) Age/sex:IP NO :
:DOA:
:DOS:
5) occupation:DOD:
6) Residence :
7) Chief Complaints : swelling in inguinoscrotal region
Onset
Duration
Progress
Aggravating factors
Relieving factors
: Pain
Vomiting
Urinary complaints
Chronic cough
Other symptoms
9) Past History
10) Treatment history – Any surgery
Systemic illness.
11) Personal History – Diet
Appetite
Bowel/Bladder
Sleep
Habits
12) Family History
13) General Physical Examination
Built Nourishment
Pulse Pallor:
BP RR
Temp Jaundice
Clubbing Cyanosis
Edema Lymphadenopathy
14) Local Examination:
INSPECTION: Size Site
Shape position and extent
Skin over swelling impulse on cough
Reducibility position of penis
PALPATION: Temp: Tenderness
Size Shape
Position and extent consistency
Impulse on coughing Reducibility
Relation of testes to testes and
Spermatic cord :
Ziemans technique
Invagination test
Ring occlusion test
PERCUSSION
AUSCULTATION
15) Other systemic examination
- abdominal system
- Respiratory system.
- Cardiovascular system.
- Central nervous system.
16) INVESTIGATIONS UNDERGONE BY PATIENT:
1) BLOOD:
Hb- gm% TC- cells/cmm. DC- N % L % M % B %
Urea mg/dl sugar(R) mg/dl s.creatinine mg/dl
2) URINE: Alb: Sugar Micro
3) ECG 4) X RAY CHEST
5) USG ABDOMEN
6) COLONOSCOPY
17) FINAL DIAGNOSIS
18) Pre-operative management:
19) Details of Surgery :
Diagnosis / Operation Procedure20) Post- operative Management;
20) Postoperative complications-
Seroma
Haematoma
Wound gaping
Swelling and induration
Testicular atrophy neuralgia
Mesh infection
Recurrence
21)Follow up at 1week
1month
6month
22) Inference :
23) Comments :
BIO – DATA
1) GUIDE
NAME : Dr. BALASAHEB BHIMRAO METAN
DATE OF BIRTH:12-03-1952
EDUCATION: M.B.B.S 1974
Dr. V.M. Medical College, ShivajiUniversity
KOLHAPUR.
M.S. GENERAL SURGERY 1980
Dr. V.M. Medical College, ShivajiUniversity
DESIGNATION : PROFESSOR OF SURGERY
TEACHING : UG TEACHER -22 YEARS
EXPERIENCEUG& PG EXAMINER
KarnatakaUniversity, Dharawad
RGUHS, Bangalore.
ShivajiUniversity, Kolhapur
MumbaiUniversity
MUHS, NASHIK
Dr. B.R.Ambedkar, MarathwadaUniversity
Aurangabad
ADDRESS : PROFESSOR
DEPARTMENT OF SURGERY
B.L.D.E.A’s Shri.B.M.PATILMEDICALCOLLEGE, BIJAPUR-586103
KARNATAKA
TELEPHONE NO. :(08352) 262770 EXT 2009
2) INVESTIGATOR
NAME: Dr. PRAVEEN CHANDRA K
QUALIFICATION: M.B.B.S, 2006.
RGUHS
KMC Reg No. : 74573 Date 29-05-06
ADDRESS : Dept. OF GENERAL SURGERY
B.L.D.E.A’s Shri.B.M.PATIL MEDICAL COLLEGE, BIJAPUR-586103,
KARNATAKA