To see the effect of bupivacaine with and without fentanyl in mothers and children following caesarean section.

Recruiting

Conditions: Caesarean section

Registration Number: CTRI/2012/04/002618

Lead Sponsor: Department of Biotechnology North Eastern Cell

Brief Summary: 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-

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 100

Inclusion Criteria

The patients posted for elective caesarean section belonging to ASA(American Society of Anaesthesiologists)grade 1 and 2 only.

Exclusion Criteria

Patient refusal,any contraindication to neuraxial blockade,pregnancy induced hypertension,placenta praevia, abruptio placentae, intrauterine growth restriction, pre-existing fetal distress.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
quality of anaesthesia(onsetof action, muscle relaxation, quality of analgesia) and duration of analgesia	From 0 hours till patient request for first dose of analgesic.

Secondary Outcome Measures

Name	Time	Method
Maternal haemodynamics (heart rate, SpO2, NIBP, MAP, respiratory rate).
Neonatal outcome (Apgar score at one and five minutes after delivery)	at one and five minutes after delivery
Rescue dose of analgesic	intraoperative and postoperative
Adverse effects of intrathecal fentanyl (nausea, vomiting, pruritis, hypotension,bradycardia, respiratory depression)	intraoperative and postoperative

Trial Locations

Locations (1): obstetric and gynaecology OT including pre and postoperative care room
🇮🇳
Tripura, TRIPURA, India
obstetric and gynaecology OT including pre and postoperative care room
🇮🇳Tripura, TRIPURA, India
Dr Debashis DebRoy
Principal investigator
9436127178
debroydebashis@gmail.com