Comparison Of Epidural Fentanyl to Epidural Dexmedetomidine on Requirement of Ropivacaine in Patient Controlled Epidural Analgesia During Labour Double Blinded Randomised Controlled Trial

·       Parturient will be explained about the procedure and informed written consent is obtained.

·       Thorough pre anaesthetic evaluation is performed  and routine investigations will be  obtained

·       Foetal status, labour status (frequency and duration of labour pain and cervical dilatation)will be assessed and noted both clinically and with Cardiotocography (CTG). A large bore peripheral intravenous catheter 18G/20G will be inserted and standard monitores such as NIBP ,Pulse oximeter, ECG,FHR monitors are connected. Baseline hemodynamic parameters will be recorded

·       Under strict aseptic precautions epidural space is identified with patient in left lateral position by midline approach using 18 G Tuohy’s needle in L3-4 or L4-L5 interspace with loss of resistance to saline technique and catheter is threaded cephalad 3 to 4 cms into epidural space. After negative aspiration for blood and CSF, a test dose of 3ml of lignocaine 2% with 1:2, 00, 000 adrenaline will be administered through the catheter, monitored for 5 min and connected to patient controlled analgesia (PCA) pump.[B BRAUN Perfusor space]

·       Patients are then randomized into two groups of 25 patients each based on randomly generated numbers as obtained from website www.randomizer.org. Allocation concealment is done using serially numbered opaque envelope (SNOSE) method into GROUP A and GroupB.

 Â·       Group A will receive the 10ml loading dose of  0.1% Ropivacaine with Dexmedetomidine 0.4mcg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr. When the NRS is ≥ 4, rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump.

·       GROUP B: will receive 10ml loading dose of 0.1% Ropivacaine with fentanyl 2μg/ml followed by continuous background infusion by patient controlled analgesia pump at rate of 6ml/hr . Patients are instructed to use the pump by pressing the button whenever they feel more pain(NRS of ≥ 4).Rapid bolus injection of 6ml with lockout period of 20minutes will be delivered by a patient controlled analgesia pump. The study drug for epidural analgesia will be prepared by another resident who is not involved in study. Patients and primary investigator both are blinded to study drug.

·       Parturients are monitored for haemodynamic parameters such as heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP),Mean arterial pressure(MAP), SpO2 ,Respiratory rate, Temperature every 10min interval for 60 minutes and thereafter hourly till completion of labour along with Fetal heart rate(FHR)

·       NRS Score[8] (numerical pain rating scale)- To assess the intensity of labour pain,0-10(0=no pain,10=worst imaginable pain). It is assessed prior to epidural catheter placement,after every 10minutes interval for 60 minutes and thereafter hourly till completion of labour

Numerical rating Scale (NRS) [14]. | Download Scientific Diagram

 Â·       The duration of stages of labour (hrs)

1ststage(starts from the onset of true labour pain and ends with full dilatation of cervix=10cm), 2nd stage (starts from full dilatation of cervix and ends with delivery of baby), 3rd stage (begins after baby delivery ends with expulsion of placenta)

·       Mode of delivery(spontaneous vaginal delivery/forceps/vacuum)

·       Incidence of caesarean delivery

·       The  sensory block- by pinprickmethod and time noted for block to reach T10 dermatomal level after administering bolus dose

·       The motor block - by modified Bromage scale[4]

Modified Bromage scale

0- No motor block

1- Inability to raise extended leg: able to move knees and feet

2- Inability to raise extended leg and move knee able to move feet

3- Complete block of motor limb

·       The patients are monitored for the adverse effect such as hypotension, bradycardia, nausea vomiting, pruritis, desaturation, maternal sedation (Ramsay sedation scale)[9]

Score

Level of Sedation

|1

Patient Is anxious and agitated or restless, or both

|2

Patient is co-operative. Oriented. and tranquil

|3

Patient responds to commands only

|4

Patient exhibits brisk response to light tactile stimuli or loud auditory stimulus

|5

Patient exhibits sluggish response to light tactile stimuli or loud auditory stimulus

|6

Patient exhibits no response

 Hypotension(less than 20% of baseline SBP) is treated with i.v ephedrine 5mg

Bradycardia(HR<60/min) is treated with atropine 0.6mg

Nausea and Vomiting treated with 4mg i.v ondansetron

After the delivery, neonatal APGAR scores at 1 and 5 minutes are assessed and managed as per neonatal resuscitation protocol

Maternal satisfaction will be assessed by using 1-5 verbal score(1=not satisfied at all  5=extremely satisfied)

Desaturation(spo2<92%) will be treated with 5-8l of oxygen by simple face mask.

·       The number of PCA demand boluses ,total consumption of 0.1% Ropivacaine , Dexmedetomidine 0.5mcg/ml and Fentanyl 2mcg/ml, hourly requirement of epidural ropivacaine ( calculated as the total consumed ropivacaine 0.1% volume divided by infusion duration) during study period will be noted and compared in both groups.