Karnataka, bangalore
Annexure II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
(To be submitted in duplicate)
- NAME AND ADDRESS OF :DR. SHWETHA K.
CANDIDATEHASANMUKHI,
LAKSHMISHNAGAR
II CROSS
KADUR POST – 577548
KARNATAKA
- NAME OF THE: MS RAMAIAH MEDICAL COLLEGE
INSTITUTION
- COURSE OF THE STUDY: MS OBSTETRICS ANDGYNAECOLOGY
AND SUBJECT
- DATE OF ADMISSION:22nd May, 2009
TO THE COURSE
- TITLE OF THE TOPIC:COMPARISON OFCONVENTIONAL
LABOUR ANALGESIA WITH SINGLE
DOSE INTRATHECAL ANALGESIA
- BRIEF RESUME OF THE INTENDED WORK
6.1Need For the Study:
Labour pain is among the most severe pain a woman can experience in her lifetime. It is compared in its intensity to severe cancer pain or the pain from amputation of digits. It has been suggested that confining a woman to bed during labour may cause the labour to be longer and more painful with an increase in abnormal presentation, instrumental deliveries, and fetal distress.
Since the labour pain is more distressing to some women, which in turn leads to abnormal uterine contractions leading to prolonged labour duration. In order to make labour smooth, short, and pleasant various analgesics/analgesia methods are being used. In epidural analgesia the expenditure is slightly more, hence there is a need for a method to decrease the cost but still can give an effective labour analgesia.
So with regards to this, single dose fentanyl with or without intrathecal bupivacaine would be studied. This study is undertaken to find out the efficacy of single dose intrathecal analgesia in terms of onset, duration of block, and quality of analgesia during labour.
6.2) Review of literature:
Intrathecal analgesia administration competes epidural analgesia in providing labour analgesia but it is faster in onset, safer, less technically demanding. Intrathecal analgesia is well received by those women who choose to have it.6
Arthur Herpolsheimer, MD and Joel Schretenthaler, MS concluded that use of intrapartum, intrathecal narcotic analgesia provides an adequate level of pain relief and high degree of patient satisfaction. Its use does not alter the normal progress of labour or its outcome. Intrathecal analgesics during labour can be administered safely and managed in a small community based hospital.1
In a study 84 parturients in active labour willing for analgesia randomly divided into 7 groups to receive either 5, 10, 15, 20, 25, 35, and 45 micrograms intrathecal fentanyl as a part of combined spinal epidural technique. They concluded that intrathecal fentanyl produced rapid profound labour analgesia with minimal side effects. The study data indicated that there was little benefit to increasing the dose of fentanyl beyond 25 micrograms, when used as a sole agent for intrathecal labour analgesia.7
6.3) Objectives of the study:
- To study the effect of single dose intrathecal analgesia with respect to analgesia and progress in labour.
- To study the effect on mode of delivery.
- To study the effect on maternal and fetal outcome.
7. MATERIALS AND METHODS
7.1 Source of data
Women in labour willing for intrathecal analgesia attending MS RamaiahHospitals.
7.2 Method of collection of data
The sample size: 30 in each arm (60)
Study design: Prospective comparative observational design
Duration of study: Prospective 1 ½ year study
Statistical Analysis: Independent T Test will be employed
60 partuerients will be taken for the study. All the women in labour attending MS Ramaiah Hospitals will be offered the choice for labour analgesia with intrathecal analgesics. Whoever gives consent will be taken as subjects in study group.
A detailed history, complete physical examination, and routine investigations will be done for all patients. IV line will be secured. The patients will be divided into 2 groups of 30 each. Group A receiving intrathecal analgesia and Group B not receiving intrathecal analgesia.
Patients VAS(visual analogue scale) pain score will be recorded every 5 min, 10, 15, 30, 45, 60, 85, 90, 105, 120 min. Every 5 min for 15 min. and then every 15 min for 2 hours.
Inclusion Criteria:
1)Healthy women at term gestation in active phase of labour.
2)Maternal request for labour analgesia.
3)Age group 18-35 years.
4)Women in active phase of labour with cervical dilatation more than 4-5 cm in primi and more than 2-3 cm in gravida 2.
Exclusion Criteria:
1)Parturients with multiple gestation.
2)Parturients with PIH, IUGR, Severe Anemia, CPD, Previos LSCS, DM, Systemic Illness, Bleeding Disorders.
7.3)DOES THE STUDY REQUIRE ANY INVESTIGATIONS TO BE CONDUCTED OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS/ANIMALS?
No.
7.4)HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.3?
Yes
- LIST OF REFERENCES:
1)Arthur Herpolsheimer, MD and Joel Schretenthaler, MS, The use of intrapartum intrathecal narcotic analgesia in a community based hospital. 1994,84(6) Obstetric and Gynaecology.
2)Martin Cascio MD, Bernard Pygon MD, Cathlene Bernett BS, Sivam Ramanathan MD, Labour analgesia with intrathecal fentanyl decreases maternal stress, Can J Anesth 1997,44(6),605-609
3)International Journal of Obstetrics and analgesia; spinal analgesia in labour; 1997,6(3)
4)Palma CM, Hays RR, Maren GV. The dose response relation of intrathecal analgesia. Anesthesiology. 1998,88:355-61
5)Susanne Ledin Eriksson, Inger Blomberg and Christina, Olofsson; Single shot, Intrathecal Sufentanil in late labour analgesia, quality and obstetric outcome. E-Journal of Obs and Gynec and repro bio, 2003, 110(2) 131-135
- SIGNATURE OF:
THE CANDIDATE
- REMARKS OF THE GUIDE:
Epidural analgesia during labor costs more than single dose intrathecal drugs, whereas the efficacy seems to be the same in both. Single dose intrathecal drug when given appropriately (with respect to time and stage of labour) can be more efficacious than epidural. Hence the right selection of cases for intrathecal analgesia is needed for smooth progress of labour.
11.1NAME AND DESIGNATION:DR. SUJANI B.K. MBBS, MD, DNB
OF GUIDESPROFESSOR
DEPARTMENT OF OBG
MS RAMAIAH MEDICAL COLLEGE
11.2SIGNATURE:
11.3CO –GUIDE:
11.4SIGNATURE:
11.5HEAD OF DEPARTMENT :DR. UMA DEVI K
SENIOR PROFESSOR AND HOD
DEPARTMENT OF OBG
MS RAMAIAH MEDICAL COLLEGE
11.6 SIGNATURE:
12. REMARKS OF THE CHAIRMAN :
AND PRINCIPAL
12.1SIGNATURE :