The study of haemodynamics and neonatal outcome following spinal anaesthesia with low dose hyperbaric bupivacaine with and without fentanyl in patients undergoing elective caesarean section.

INTRODUCTION

Hyperbaric  bupivacaine  is  being used  as  a  spinal  anaesthetic for a  long time, to  conduct caesarean section throughout the globe. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

A large  dose  of  the  anaesthetic (within clinical range)  is  required  to obliterate the visceral  pain  in  caesarean section, associated  with undesirable  side effects.

Neuraxial  opioids  may  augment  the  analgesia  by  local  anaesthetic, reducing  the dose  of  bupivacaine   necessary   to achieve adequate surgical anaesthesia .

The   lipophilic   opioid   agonist  fentanyl ,  produce   rapid  onset  of   analgesia,  more   denser block with adequate  height and  depth of  anaesthesia  and  may  decrease  the  incidence of  hypotensive   episodes,  vasopressor   requirement  and  nausea  with  improved neonatal outcome, reducing  the dose requirement of hyperbaric bupivacaine.

In our  study  we  will  try  to  find  out  whether  after  adding  fentanyl  to  low dose hyperbaric bupivacaine  can  modify  side effects of  higher doses  of  hyperbaric bupivacaine leading to improved  maternal  haemodynamic  stability, quality of  anaesthesia and analgesia along with neonatal outcome .

AIMS AND OBJECTIVES

AIMS

The aim of the present study is to observe the effect of intrathecal fentanyl 12.5mcg with low dose hyperbaric bupivacaine compared to intrathecal low dose hyperbaric  bupivacaine alone with regards to its  onset  of  action, intra-operative  haemodynamics,  quality  of   analgesia, degree  of  muscle  relaxation, duration of  analgesia  and  any adverse effect on mother and newborn, following elective caesarean section.

OBJECTIVES.

1.To know any maternal  adverse effect of intrathecal fentanyl (opioid) in the background of altered haemodynamics due to spinal anaesthesia itself.

2. To  ascertain the effect of fentanyl given as additive to low dose  hyperbaric bupivacaine in spinal anaesthesia in elective caesarean section on fetal outcome.

MATERIALS AND METHODS

The study will be done after approval of  the ethical and screening committee of AGMC and GBP hospital. Written and informed consent will be obtained from all  the patient  prior  to procedure.

1.STUDY PERIOD:  one  year (January 2012 to December 2012)

2.STUDY AREA:  Department of anaesthesiology, Obstetrics and Gynaecology operation

theatre, GB Panth hospital.

3.STUDY DESIGN: Double blind randomised controlled  trial  study.

2.STUDY POPULATION:

Inclusion criteria:

:All patients posted for elective caesarean section belonging to ASA  grade 1 and 2

only.

Exclusion criteria:

: Patient refusal, contraindication to neuraxial blockade, APH, IUGR, pre-existing

fetal distress and other medical disorders associated with pregnancy.

SAMPLE SIZE: 100 term pregnant mothers in the age group of 20 to 35 years of age

fulfiling all the  inclusion  and  exclusion  criteria and posted for elective  caesarean  section

will  be  equally  and  randomly  allocated  in  two groups (50 in each groups); group B

(control group)  and  group BF(study group).

   PARAMETERS TO BE STUDIED:

: Onset and duration of  analgesia.

: Maternal PR,NIBP,MAP, E.C.G, SpO2,RR.

: Level of sensory and Motor block.

: Adverse effects (mother and newborn).

: Side effects of  opioid  agonists.

:Fetal outcome- Apgar score of the newborn at one minute and five minute after

birth.

STUDY TOOLS:

(1)Consent form.

(2) Pre-designed and pre-tested question-ire.

(3)Anaesthesia machine with gas.

(4)Endotracheal intubation trolley.

(5)Multiparameter monitor.

(6) Disposable spinal needle.

(7)Disposable syringe and relevant drugs.

PLANS FOR STATISTICAL EVALUATION:

Relevant  clinical  data will  be analysed, using  appropriate  statistical test, to find the  significant  association  in  clinical factors  between the two groups. The p value of <0.05 will  be considered  significant  and the  p value  of <0.01 as highly significant.

  METHOD:

After 6  hours  fasting   i.v.  line  will  be  secured   and   all   base line  clinical   data  (mother as well as fetus) to  be  recorded .  After  preloading  with   500ml  RL solution   and premedication  spinal   anaesthesia  will  be  administered  at   L3-4 space   and   either  control drug  or  test  drug  will  be administered as per the random assignment under full aseptic and antiseptic  care . Oxygen  will  be  administered  by  facemask . The  vital parameters will be monitored  throughout and after  the procedure till requested for analgesics.

The neonate will be observed for Apgar  score at 1 and 5 minutes. Any maternal side effect will   be   noted   and    appropriately   treated.   Appropriate    neonatal   resuscitative   measures  will be taken in accordance to neonatal  outcome.

Urinary bladder  will  be  catheterised in  all  patients  before  the  start  of   the

surgery, until 24 hours post-operatively.

INDEX OF REFERENCES

1. Mebazaa  M S,  Ouerghi  S, Ben Meftah  R B, Cheikh  M B, Mestiri  T, Ammar  M S B, Kuint  J : Reduction of   bupivacaine  dose  in spinal  anaesthesia  for caesarean section may improve maternal  satisfaction by reducing  incidence  of    low  blood pressure   episodes. M.E.J. ANESTH 2010;20(5):673-78.

2. Belzarena S: Clinical effects off intrathecally administered fentanyl in patients undergoing caesarean section. Anesth Analg 1992;74:53-7.

3. Ben-David  B, Miller G, Gavriel R, Gurevitch A: Low  dose  bupivacaine fentanyl   spinal anaesthesia  for caesarean deliveries. Reg Anesth and Pain Med 2000;25:235-39.

4. Harsoor S S, Vikram M S : Spinal anaesthesia with low dose bupivacaine with  fentanyl for caesarean section. SAARC J.Anaesth 2008; 1(2): 142-45.

5. Maayan- Metzger A,   Schushan-Eisen  I ,  Todris  L , Etchin  A :   Maternal   hypotension  during  elective  caesarean  section  and  short-term  neonatal outcome. Am J Obstet Gynecol 2010; 202:56.e1-