Rajiv Gandhi University Of Health Sciences, Karnataka,
Bangalore
Annexure II
PROFOMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. Name of the candidate DR. THAKKER CHARMI BIPIN
and address (in block letters) FLAT NO – 4, PLOT NO – 74,
SECTOR – 21,
NERUL (EAST),
NAVI MUMBAI – 400706
2. Name of the institution J.S.S. MEDICAL COLLEGE
3. Course of study and M. S. (OBSTETRICS AND
subject GYNECOLOGY)
4. Date of admission to 31ST MAY
the course
5. Title of the topic
“A CLINICAL STUDY OF PROGRESS OF LABOUR AND ITS
OUTCOME WITH COMBINED SPINAL EPIDURAL
ANALGESIA”.
6. Brief resume of the intended work
6.1Need for the Study:-
Pain is not only the single most fearful thought regarding normal delivery but also the painful uterine contractions cause maternal hyperventilation and increased catecholamine concentration resulting in maternal and fetal hypoxia. An effective analgesic in labour takes away these disadvantages and helps for a better maternal and fetal outcome.
Combined spinal epidural technique gives excellent analgesia combining the benefits of spinal anesthetic that is rapid onset and very low failure rates and that of epidural analgesia allowing for flexibility and continuous infusion. This technique causes minimal motor blockade and allows for ambulation during labour and leads to greater maternal satisfaction. It is not associated with any increase in Caeserean-section rates; instrumental deliveries or PDPH(Post Dural Puncture Headache).
Many times more importance is given to the analgesic effect of the technique than its effect on the progress of labour. This study intends to study the effect of Combined Spinal-Epidural Analgesia on progress of labour, its outcome, maternal satisfaction with analgesia and the neonatal outcome
6.2 Review of literature
Soresi performed the first intentional Combined spinal-epidural anesthesia in 1937. Dr. Morgan of Queen Charlotte’s Hospital, London introduced the technique of Combined spinal-epidural analgesia for labour into UK practice in 19931.She reported a case series of 300 women who received Combined spinal-epidural analgesia for labour. Her technique used subarachnoid component to provide rapid effective analgesia with minimal motor blockage and the epidural component to maintain analgesia. The lack of motor blockade was such as to allow mobilization during labour, hence the description of “Walking epidurals”.
Combined spinal-epidural analgesia combines benefit of both, the rapid onset2 of spinal analgesia & the flexibility of the epidural catheter. Intrathecal sufentanil provides rapid onset and profound analgesia without any adverse maternal or fetal outcome3. Combined spinal-epidural analgesia has been in general shown to produce higher maternal satisfaction with analgesia and mobility as reported in the post-partum period by mothers, without any alteration in obstetric management or postpartum care of the mother.4
Also, Combined spinal-epidural analgesia in healthy nulliparous parturient in early labour, is associated with more rapid cervical dilatation. The first stage of labour and the total stage of labour have been found to be shorter than in parturients receiving no analgesia.5
The Combined spinal-epidural analgesia may modify the normal compensatory mechanisms of BP control but does not cause significant maternal hypotension once spinal injection has been given. The patient controlled epidural top-ups with maternal mobility may be beneficial to the fetus possibly by reducing the hypotension normally associated with top-ups in lying down position.6
The Combined spinal-epidural analgesia technique is potentially beneficial to the fetus by decreasing the total amount of local anaesthetic and opioid required but some authors have reported increased fetal heart abnormalities in the form of fetal bradycardia. Clarke et al suggested that fetal bradycardia may be associated with the use of intrathecal fentanyl, possibly due to uterine hyperactivity.7
Neuraxial analgesia in the form of Combined spinal-epidural analgesia & patient controlled epidural analgesia not only offers the most effective form of obstetric pain relief but also it does not increase the risk of caesarean section.9 No difference between Combined spinal-epidural analgesia epidural techniques with respect to incidence of forceps delivery, PDPH (Post Dural Puncture Headache), Caeserean-Section rate or admission of babies to NICU(Neonatal Intensive Care Unit) have been found.9
In general, no difference in side effects except for mild pruritis, which is more common in Combined spinal-epidural analgesia, has been reported.10
6.3 Objectives of the Study:
1. To study the effect of Combined spinal-epidural analgesia on the progress of labour using a partogram.
2. To assess the maternal satisfaction of pain relief with Combined spinal-epidural analgesia.
3. To assess the maternal and fetal outcome.
7. Material and methods:
7.1 Source of data
Patients admitted to the labour ward of J.S.S.Hospital during the study
Period of Nov 2007 to Sept 2007 with a minimum of 50 cases and 50 controls.
7.2 Method of collection of data ( Including sampling procedure, if
any)
It is a hospital based study. The design of the study is a randomization trial. The parturients receiving Combined Spinal-Epidural analgesia for labour will be compared with parturients not receiving any form of analgesia as controls. The cases in each group will be randomly allocated.
History taking and clinical evaluation will be done.
Data will be collected in a preformed proforma.
Valid consent will be taken.
Spinal analgesia with Bupivacaine and sufentanyl for labour analgesia will be given (2.5mg Bupivacaine +0.1ml of sufentanyl)
When patient complains of pain epidural top-ups will be given.
(10ml of 0.125 Bupivacaine +0.3 mcg/ml of sufentanyl)
The progress of labour in both the cases receiving Combined Spinal-Epidural Analgesia & controls will be recorded in a partogram.
Maternal parameters like heart rate, blood pressure, respiratory rate, motor blockade, level of sensory blockade and assessment of pain by visual analogue scale will be recorded.
Fetal Heart Rate will be continuously monitored and any variation will be noted.
Maternal outcome in the form of normal delivery, prolonged labour, instrumental delivery, Caeserean-section will be noted.
Neonatal outcome in the form of Neonatal Intensive Care Unit (NICU) admission will be noted.
The data will be analysed using appropriate statistical methods.
Inclusion Criteria:
1. Singleton pregnancy
2. Vertex presentation
3. Term gestation
4. Patient in active phase of labour with cervical dilatation 3-5cms with intact membranes with satisfactory uterine contractions.
Exclusion Criteria:
1. Malpresentation
2. Preterm labour
3. Any fetal anomalies
4. Medical disorders complicating pregnancy – hypertension, heart disease, anemia, HELLP
5. Obstetric complications – antepartum hemorrhage, Intra Uterine Growth Retardation (IUGR) etc.
6. Contraindications for regional analgesia
7.3 Does the study require any investigation or intervention to be
conducted on patients or other humans or animals? If so please
describe briefly
Yes, routine blood and urine investigations, cardiotocogram for
monitoring FHR are required.
7.4 Has ethical clearance been obtained from your institute in case of
7.3?
Yes, certificate enclosed.
8. List of References:
1. Collis RE, Baxandall ML, Srikantharaj ID, Edge G, Kadim MY, MorganB.M. Combined spinal epidural analgesia with the ability to walk throughout labour. Lancet 1993 ; 341 : 767-68.
2. Neckells JS, Vaughan DJA, Lilly white NK, Laughnum B, Hasan M, Robinson PN. Speed of regional anesthesia in labour. A compression of the epidural and spinal routes. Lippincot Williams and Wilkins. Obstetrical and Gynecological survey sept 2000 ; 55(9) : 543-544.
3. Frikha N, Ellanchtar M, Mebassa MS, Benamar MS. Combined spinal – epidural analgesia in labour – comparison of sufentanyl vs tramadol. Middle east J Anesthesal 2007 ; 19(1) : 87-96
4. Collis RE, Baxandale ML, Sri kantharajah ID, Edge G, Kadim MG, Morgan BM. CSE technique, management and outcome of 300 mothers. Int J obstet Ansth 1994 Apr ; 3 (3) : 75-81.
5. Jix, Qitt, Liu A. Clinical study of labour pain relief using the Combined Spinal Epidural Analgesia associated with more rapid cervical dilatation in nulliparous when compared with conventional epidural analgesia. Anesthesiology 1999 Oct; 91(4); 920-5.
6. Al mutti R, morey R, Shennon A, morgan B. Blood pressure and fetal heart rate changes and patient controlled Spinal-Epidural analgesia in labour Br. J Obstet Gynaecol 1997 May;104 (5): 554
7. Garke VT, Smiey RM, Finster M. Uterine hyperactivity after intrathecal injection of fentanyl for analgesia during labour. A cause of fetal bradycardia? Anesthesiology 1994; 81.1083.8.
8. Schneider MC. Walking epidurals : mobilization during neuraxial labour analgesia. Anasthesiol Intensiumed Notfallmed Schmerzther. 2007 ; 42(5) : 352-9
9. Trikha A. Analgesia and Anesthesia in pregnancy. Mishra R. Editor. Ian Donalds practical obstetrical problems ; 2007, Edward Arnold publishers Ltd, sixth edition.
10. Collies RE, Davies DW, Aveling W. Randomised comparision of CSE and Standard epidural analgesia in labour. Lancet 1995 Jun; 3, 345 (8962):1413-6.
9. Signature of the candidate:
10. Remarks of the Guide:
Combined spinal epidural technique gives excellent analgesia
combining the benefit of spinal analgesia that is rapid onset and less
failure rate and the flexibility of epidural catheter. This study allows us
to know the importance of its analgesic effect as well as study its effect
on the progress of labour and its outcome.
11. Name and designation of
(in block letters)
11.1 Guide : DR. SOWJANYA M. S.
ASSOCIATE PROFESSOR
DEPARTMENT OF OBSTETRICS AND GYNECOLOGY
J.S.S. MEDICAL COLLEGE
MYSORE
11.2 Signature :
11.3 Co-guide (if any) : DR. P. AKKAMAHDEVI
PROFESSOR
DEPARTMENT OF ANESTHESIOLOGY
J.S.S. MEDICAL COLLEGE
MYSORE
Signature :
11.5 Head of the department : DR. AMBARISHA BHANDIWAD
PROFESSOR AND HEAD OF
THE DEPARTMENT OF OBSTETRICS
AND GYNECOLOGY
J.S.S. MEDICAL COLLEGE
MYSORE
11.4 Signature :
12. 12.1 Remarks of the chairman and the principal :
12.2 Signature :