RAJIV GANDHI UNIVERSTTY OF HEALTH SCIENCES
KARNATAKA BANGALORE
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / Dr BHAVANI.S.YPG IN OBSTETRICS AND
GYNAECOLOGY
CHELUVAMBA HOSPITAL
MYSORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
2. / NAME OF THE INSTITUTION / MYSORE MEDICAL COLLEGE AND
RESEARCH INSTITUTE, MYSORE
3. / COURSE OF STUDY & SUBJECT / M.S OBSTETRICS & GYNAECOLOGY
4. / DATE OF ADMISSION TO THE COURSE / 02/05/09
5. / TITLE OF THE TOPIC / A CLINICAL COMPARATIVE STUDY OF INTRAPARTUM EPIDURAL ANALGESIA WITH INTRAMUSCULAR TRAMADOL
WITH RESPECT TO MATERNAL & FETAL OUTCOME
6) BRIEF RESUME OF THE INTENDED WORK.
6.1 NEED FOR THE STUDY
Labour pain ranks among the severest form of pain, described as intolerable by a third of women .The ability to produce pain relief is desirable enough in its own right.
Of various methods of labour analgesia like psychoprophylaxis. Systemic opioids, regional nerve block etc…, lumbar epidural analgesia has potential to be such a technique .It achieves analgesia in labour without clouding of consciousness, allowing the mother to be fully alert throughout labour & giving her the opportunity to interact with her child immediately after birth. So epidural analgesia produces a very effective pain relief & has become a very popular method of labour analgesia.
Pain during labour can release catecholamines & these can produce constriction of the uteroplacental vessels there by decreasing uteroplacental circulation leading to fetal hypoxia & acidosis. Increased levels of catecholamines can also relax the uterus & prolong the duration of labour. Pain will produce maternal hyperventilation leading to hypocarbia & respiratory alkalosis. This will further produce reduction in the uteroplacental blood flow & also shifts the oxyhaemoglobin curve to the left producing further fetal hypoxia. Hence an effective form of pain relief will help in the wellbeing of the fetus & also may hasten the stages of labour
In olden days epidural analgesia was produced using higher concentration of local anaesthetics which used to produce motor blockade leading to increased incidence of instrumental deliveries. In recent years, lower concentration of local anaesthetics are used because of the addition of opioids like fentanyl. This has definitely decreased the incidence of instrumental delivery .
Labour analgesia is also produced by using non epidural methods like systemic opioids, tramadol. It has been found that this method may not produce effective labour analgesia and hence all the problems due to pain can persist.
Hence a study is reqired to compare the effect of intrapartum epidural analgesia with nonepidural analgesia like intramuscular tramadol, with respect to maternal & fetal outcome.
6.2 REVIW OF LITERATURE
1. Desai pankaj, patel puri, Gupta Ashoo, Virk gurpreet kaur, Sinha Archana in 2006 Epidural analgesia in labour – concluded that epidural analgesia is a safe & effective method for labour pain relief. With active management of labour it does not significantly alter the labour characteristics. Journal of Obstet and Gynecol of India Vol. 56, no5 ; Sep / Oct 2006 pg 417-422
2. Epidural analgesia : - Effect on labour progress & maternal & neonatal out come . pubmed review 1; semin perinatol 2002 Apr ; 26(2) ; 122-35 .Leighton BL Halpern SH .
The intended & unintended effects of epidural analgesia are reviewed. Mothers randomized to epidural rather than parenteral opioid analgesia have better pain relief. Fetal oxygenation is not affected by analgesic method , however neonates whose mothers received intravenous or intramuscular opioids require more naloxone & have lower APGAR scores. Epidural analgesia is associated with longer second stage , more frequent oxytocin augmentation & maternal fever but not with longer first labour stages. Epidural analgesia has no effect but intrapartum opioids decrease lactation success.
3. Effect of epidural vs parenteral opioid analgesia on the progress of labour JAMA 1998 : 280 : 2105-2110 . A Metaanalysis .Randomised trials comparing rates of cesarean delivery using epidural anaesthesia vs parenteral opioids. Epidural labour analgesia is not associated with increased rates of instrumental vaginal delivery for dystocia or cesarean delivery. Patients receiving epidural analgesia have longer labours. Patient satisfaction & neonatal outcome are better after epidural than parenteral opioid analgesia.
4. Williams obstetrics 22nd edition states that according to Friedman’s original criteria, epidural analgesia prolongs the active phase of labour by 1 hour & duration of second stage is increased approximately by 25min. Epidural analgesia increased the need for instrumental delivery due to prolonged second stage of labour studies conducted at parkland hospital showed epidural analgesia did not significantly increased the cesarean deliveries in any individual trial or in their aggregate. Reynolds & co-workers found that epidural analgesia was associated with improved neonatal APGAR Scores compared to opioid analgesics
5. Ian Donald’s practical obstetric problems 6th edition 2007 Epidural pain relief is one of the most popular & effective method to alleviate labour pain. Systematic reviews of radomised controlled trials show that there is an increased duration of II stage of labour & risk of instrumental delivery in women who receive epidural analgesia in labour compared to other methods of pain relief however, the incidence of cesarean section is not increased. There is no evidence of low neonatal APGAR Scores at 5 min after an epidural
6.3 objectives of the study
i) To compare the effect of intrapartum epidural analgesia with intramuscular tramadol in pain relief
ii) To compare the effects of intrapartum epidural analgesia with intramuscular tramadol on labour characteristics , maternal & fetal outcome.
iii) To study the intrapartum complications of epidural analgesia
7. Materials & methods
7.1. Source of data : primigravida with low risk pregnancy coming to labour ward in cheluvamba hospital attched to Mysore Medical College & Research Institute , Mysore during the period of one and half year, from may 2010 to november 2011.
7.2 Method of collection of data : primigravidae are randomly devided into 2 groups .
Group I – women who are given epidural analgesia at 3-4 cm of cervical dilatation .
Group II – women who are given intramuscular tramadol 100 mg at 3-4cm of cervical dilation .
Group I mothers will be given continuous lumbar epidural analgesia using 0.125% bupivacaine + 2 Micro grams of fentanyl using intermittent bolus & infusion technique by the anaesthesiolosist.
GroupII mothers will be given inj tramadol 100 mg intramuscularly & repeated after 4 hrs if required.
Pain relief is in both the groups is compared by using visual analogue scale
These 2 group will be compared regarding the following characteristics.
1. Duration of labour (active phase of I stage & II stage of labour )
2. mode of delivery
3. APGAR score of the new born (1 min & 5 min)
4. Untoward reaction & intrapartum complications
5. overall satisfaction of the mother.
Continuous monitoring of the haemodynamic parameters [ pulse rate , blood pressure, ECG & O2 saturation ] of the mother is done using multiparameter monitors. Mothers of both group are given continuous supplemental oxygen.
Fetal monitoring is done using continuous CTG monitor
Anaesthesia machine with all resuscitative equipment along with emergency drugs are kept ready .
For statistical analysis student – t test & chi – square test will be used & results are recorded in the tabulated form.
7.3.A. Inclusion criteria
1. Primigravidae
2. Age group between 18years - 30 years
3. Height above 145 cm
4. single live fetus with term gestation with vertex presentation
5. Women in active phase [ that is 3-4 cm of cervical dilatation] with spontaneous onset of labour pain and good uterine contractions.
7.3.B. Exclusion criteria
1. Multigravida
2. Age less than 18 years or above 30 years .
3. High risk pregnancy
4. Induced labour
7.4. Does the study require any investigation / intervention to be conducted on patients / humans / animals / If so , describe briefly
- No -
7.5 Has cthical clearance been obtained from your institution in case of 7.4 / obtained ? (copy enclosed )
…………………………………………………………………………………………
8. LIST OF REFERENCES
1. Nageria Tripti, Acharya Jyotsna , Pain relief in labour – Tramadol versus Pentazocine: Journal of Obstetrics & gynecology of India vol 56, no 5 sept/oct 2006 pg no406- 409.
2 Anim- somuah M, Smyth R, Howell C; Epidural versus non epidural or no analgesia
in labour.
Cochrane Database syst Rev 2005 Oct 19: (4) : CD000331)
3. Jain S, Arya V.K.,Gopalan et al. Analgesic efficacy of i.m.opioids versus epidural analgesia in labour: International journal of Obstetrics & Gynaecology 2003; 83:19- 27.
4. H.L. Keskin, E.Aktepe Keskin, A.F.Avsar, M. Tabuk, G.S. Caglar; Pethidine versus tramadol for pain relief during labour: International journal of Gynecology Obstetrics vol 82, Issue 1 pages 11- 16 (July 2003)
5. Alexander JM sharma S.K. , Mc Intire DD , et al ; Epidural analgesia lengthens the Friedman active phase of labour: obstet gynecol 100:46,2002.
6. Reynolds F, Sharma SK , Seed PT : Analgesia in labour and fetal acid base balance : A meta analysis comparing epidural with systemic opioid analgesia:
Br.J obstet gynecol 109 : 1344, 2002
7. Liberman E, O’Donoghue C : Unintended effects of epidural analgesia during labour: A systematic review: Am J obstet gynecol 186 : 531, 2002.
8. Charlotte J Howell, Tracy Dean , Linda Lucking, Krysia Dziedzic, Peter W Jones, Richard B Johanson – randomized study of long term outcome after epidural versus non epidural analgesia during labour: British Medical Journal, vol(7360); Aug 17, 2002.
9. Rogers R Gilson G Kammerer Doak D Epidural analgesia and active management of labour. Effects on length of labour and mode of delivery: obstets gynecol 93: 995, 1999
10. S.S.Arulkumaran,S.S. Ratnam, K. Bhaskar Rao – Management of labour; orient Longman publication, page no. 43-53.
9. Signature of the candidate :
10. Remarks of the guide : Study approved subject to modification
according to the response, since it is a clinical study.
11. Name and designation of
11.1 Guide : prof Dr. S Radhamani MD OBG
Professor
Department of obstetrics and Gynecology
Mysore medical College and research Institute.
11.2. Signature of the Guide :
11.3 Co – Guide if any :
11.4 Signature of Co – Guide :
11.5 Head of the Department : Prof Dr.HC Lokesh Chandra MD OBG
Professor and HOD
Dept of obstetrics and gynaecology
MMC RI
11.6 Signature of the Head of
the department
12. Remarks
12.1 Remarks of the chairman :
and Principal
12.2 Signature :
ETHICAL COMMITTEE CLEARANCE
1. TITLE OF DISSERTATION : A CLINICAL COMPARATIVE
STUDY OF INTRAPARTUM EPIDURAL ANALGESIA WITH INTRAMUSCULAR TRAMADOL WITH RESPECT TO MATERNAL& FETAL OUTCOME.
2. NAME OF THE CANDIDATE : DR. BHAVANI S.Y
3. SUBJECT : M.S. OBG.
4. NAME OF THE GUIDE : PROF DR.S. RADHAMANI
DEPT OF OBSTETRICS AND GYNAECOLOGY
M.M.C R.I, MYSORE.
5. APPROVED / NOT APPROVED :
(IF NOT APPROVED, SUGGESTION)
MEDICAL SUPERINTENDENT MEDICAL SUPERINTENDENT
K R HOSPITAL CHELUVAMBA HOSPITAL
MYSORE MYSORE
PROFESSOR AND HOD PROFESSOR AND HOD
DEPT OF MEDICINE DEPT OF SURGERY
MMC RI MMC RI
DR. LAKSHMAN DEAN AND DIRECTOR
PKTB HOSPITAL MMC RI
LAW EXPERT