Comparison of Sequential spinal anesthesia technique v/s Premixed bolus dose of Inj. Hyperbaric Levobupivacaine (0.5 percentage) with Inj. Fentanyl (25 ug) for patients undergoing cesarean section surgery: A Randomized Controlled Study

AIM

Comparison of block characteristics between sequential spinal anaesthesia technique and bolus dose of spinal anaesthesia technique in the patients of cesarean section surgery under spinal anaesthesia.

OBJECTIVES:

PRIMARY OBJECTIVE:

·                Time to achieve level of sensory blockade(T6) (mins)

SECONDARY OBJECTIVES:

·                Time to achieve motor blockade

·                Hemodynamic stability

·                Duration of analgesia

·                To observe any complication (Bradycardia, Hypotension, Shivering, Nausea, Vomiting, Pruritus, Urinary retention)

METHODOLOGY:

Ethical consideration- The principles of Helsinki declaration will be followed throughout the study. This study will be conducted after getting approval from local ethical committee of GMERS medical college and Hospital, Gotri, Vadodara. It will be registered with clinical trial registry of India. Written and Informed consent will be taken from all participants. Data collected will be kept confidential.

Study design-      Randomized controlled study, Double blind, parallel group

Study setting- Tertiary care teaching hospital (GMERS Medical college and Hospital), Gotri, Vadodara.

Study duration- Approx. 6 months

Study population- Patients posted for open unilateral inguinal hernia surgery.

INCLUSION CRITERIA:

1.                   Age-18 to 40 years of age

2.                   Weight –50-80kgs

3.                   Height – 150-170cm

4.                   Parturients with singleton pregnancy

5.                   ASA-2

 EXCLUSION CRITERIA:

1.                   Patient with absolute & relative contraindications of spinal anaesthesia

2.                   Allergy to Local anaesthetics

3.                   Parturient with multiple pregnancy (twin pregnancy or triplet)

4.                   Patient’s refusal to take part in study

5.                   Pregnancy with eclampsia or preeclampsia

6.                   Pregnancy with Abruptio placenta , placenta previa, placenta accreta, placenta percreta or placenta increta etc.

Study procedure:

Randomization and allocation**:** Patients will be randomly divided into two groups by simple randomization (single block) 1:1 uniform allocation. Randomization and allocation will be conducted by an independent person, not involved in the study. The sequential random numbers assigned to study participants will be kept in sealed opaque envelops, to be opened after recruitment of the participants in the study, just before giving the spinal anaesthesia. The groups are as follows:

Group B:

Inj. Levobupivacaine 0.5% 1.5 ml+ Inj. Fentanyl 25mcg 0.5ml (the drug will be taken in a 5cc syringe)

Group S:

Inj. Fentanyl 25mcg 0.5ml followed by Inj. Levobupivacaine 0.5% 1.5 ml (the drugs will be taken in two separate syringes-2 cc & 5 cc respectively)

 INTERVENTION:

Pre-operative assessment and selection of Patients: A thorough pre-operative assessment of the patients of caesarean section surgery under spinal anaesthesia will be carried out and the details will be recorded in the proforma. History will be taken regarding present and past complaints, personal history, medication history, history of previous anaesthesia exposure, blood transfusions, jaundice etc. General and systemic examination will be done. Routine and specific investigations will be carried out as and when indicated.After securing 18 G or 20G intra venous line, intravenous fluid (Inj. RL) will be started.

 SEQUENTIAL SPINAL ANESTHESIA TECHNIQUE

Under all aseptic & antiseptic precautions spinal anaesthesia willbe given in L3–L4 intervertebral space in sitting position in all cases. 23G Quincke’s spinal needle will be inserted. After confirmation of free CSF flow, with the bevel of the needle pointing upwards, drug will be injected  intrathecally.

In this method, Inj. Fentanyl 25mcg 0.5 ml taken in a 2cc syringe will be injected first immediately followed by Inj. Levobupivacaine 0.5% 1.5 ml taken in a 5cc syringe without aspiration.

Inj PARACETAMOL will be given 15 mins before completion of procedure in both the groups

  BOLUS DOSE OF SPINAL ANESTHESIA TECHNIQUE

Under all aseptic & antiseptic precautions spinal anaesthesia will be given in L3–L4 intervertebral space in sitting position in all cases. 23G Quincke’s Spinal needle will be inserted. After confirmation of free CSF flow, with the bevel of the needle pointing upwards, drug will be injected intrathecally.

In this method, Inj. Levobupivacaine 0.5% 1.5 ml and Inj. Fentanyl 25 mcg 0.5ml will be mixed and bolus injection given.

DATA COLLECTION:

Sensory block (by pin prick method) will be assessed every 15 sec for 2min and then every min for 10 min after completion of intrathecal injection of the drug.

Time to achieve sensory level (time interval between complete subarachnoid drug injection to onset of complete loss of pinprick sensation at sensory level T8) in mins.

Motor block will be assessed with the help of bromage scale (ask the patient to raise her leg without bending from the knee) after complete subarachnoid drug injection.

Hemodynamic parameters will be assessed immediately after complete subarachnoid drug injection, at 3 mins, 5 mins, 10 mins, 15 mins, 20 mins, 30 mins, 45 mins and 1 hour after complete subarachnoid drug injection.

OUTCOME MEASURES:

Primary outcome-

·                Difference in time to achieve level of sensory block in both the groups.

Secondary outcomes-

·                Characteristic of motor blockade

·                Comparison of Hemodynamic stability

·                Duration of analgesia

·                Look for any complications