Comparision of efficacy of intrathecal hyperbaric(0.75%) Ropivacaine with fentanyl and hyperbaric (0.5%) Bppivacaine with fentanyl in elective lower abdominal surgeries-A prospective randomised double blind clinical study

This study is randomised controlled trial comparing efficacy of intrathecal hyperbaric ropivacaine (0.75%)with fentanyl and hyperbaric bupivacaine (0.5%) with fentanyl for sensory and motor blockade charactrristics in elective lower abdominal surgery for subarachanoid block

Grouping of Patients-

The patients will be randomly allocated into two groups by using computer Generated random numbers which is contained in a sealed envelope

Group RF Inj. Hyperbaric Ropivacaine 0.75% 3 ml + fentanyl 25 mcg(0.5ml)

Group BF  Inj. Hyperbaric Bupivacaine 0.5% 3 ml+ fentanyl 25 mcg(0.5 ml)

After preoperative evaluation and 8 hours of fasting informed written consent will be taken from the patient

Then patient will be taken inside operation Theatre multipara monitor will be attached and all baseline parameters will be recorded

Good iv access will be taken and premedication and adequate preloading will be done 30 mins prior to induction

DRUG PREPARATION

Group RF – Inj.Hyperbaric 0.75% Ropivacaine 3 ml + fentanyl 0.5ml (25 mcg) Total drug volume=3.5 cc

Injection Ropivacaine heavy ampoule available in 0.75% 4 ml, each ml contains 7.5 mg drug, out of which 3 ml drug will be taken that is 22.5mg

Injection fentanyl ampoule available in 2 ml each ml contains 50 mcg drug out of which 0.5 ml drug will be taken that is 25 mcg

Group BF - Inj. Hyperbaric 0.5% Bupivacaine 3 ml+ Fentanyl 0.5 ml (25mcg)Total drug volume=3.5 cc

Injection Bupivacaine heavy ampoule available in 0.5% 4 ml, each ml contains 5 mg drug out of which 3 ml drug taken that is 15 mg

Injection fentanyl ampoule available in 2 ml, each ml contains 50 mcg drug out of which 0.5 ml drug will be taken that is 25 mcg

Total drug volume=3.5 cc

The patient will be kept in lateral position and under all aseptic and antiseptic precautions  using a 23 G Quincke spinal needle s will be inserted in  L3 -L4 intervertebral space (midline approach). After confirmation of free and clear CSF flow with the bevel of the needle pointing cephalic drug will be injected intrathecally 0.2ml/seconds according to Group.

Patient is immediately put in supine position without raising extremities and keeping operation table horizontal position ,monitoring of parameters will be started immediately.

Surgery will be allowed once the sensory blockade(T10) and motor blockade (Bromage 3) are achieved.

Following parameters will be recorded in both of groups.

Sensory blockade characteristics -

1)Onset of sensory Block at L1 level(min)

2)Time to achieve highest sensory level(min)

3)Time of two segment regression from highest level of block(min)

4. Duration of sensory block(min)

Motor blockade charactrristics -

1. Onset of motor blockade(min)

2. Maximum motor blockade achieved(min)

3. Time to attain maximum motor block(min)

4. Duration of motor block(min)

Intra operative monitoring of pulse rate,blood pressure and spo2 will be monitored continuousily at regular intervals(baseline,1st,3rd,5th minute,10 minutes,every 10 minutes till 30 minutes,then half hourly till end of surgery.

Time to first micturation (min)

Time for mobilisation (min)