Comparison of Sequential spinal anesthesia technique versus Premixes bolus dose of Injection Hyperbaric Levobupivacaine(0.5%) with Injection Fentanyl (25 ug) for patients undergoing open unilateral inguinal hernia surgery: A Randomized Controlled Study

AIM

Comparison between sequential spinal anesthesia technique and bolus dose of spinal anesthesia technique for time to achieve highest level of sensory block and hemodynamic stability in patients of open unilateral inguinal hernia surgery.

OBJECTIVES:

PRIMARY OBJECTIVE:

·      Time to achieve level of sensory blockade(T8) (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. 1 year

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

INCLUSION CRITERIA:

Age-18 to 60 years of age

BMI-18.5 to 24.9 kg/m2

Gender-Male & Female

ASA-1/2

Patient posted for Open Unilateral Inguinal Hernia surgery.

 EXCLUSION CRITERIA:

Patient with absolute & relative contraindications of spinal anesthesia

Allergy to Local anesthetics

Pregnant & Lactating Female

Patient’s refusal to take part in study

Height of the patient- <150cm, >175cm

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 anesthesia. The groups are as follows:

Group B:

Inj. Levobupivacaine 0.5% 2.5 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% 2.5 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 posted for open unilateral inguinal hernia surgery under spinal anesthesia 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 anesthesia 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 intra venous line, intravenous fluid (Injection RL) will be started.

SEQUENTIAL SPINAL ANESTHESIA TECHNIQUE

Under all aseptic & antiseptic precautions spinal anesthesia 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, Injection Fentanyl 25mcg 0.5 ml taken in a 2cc syringe will be injected first followed by Injection Levobupivacaine 0.5% 2.5 ml taken in a 5cc syringe.

BOLUS DOSE OF SPINAL ANESTHESIA TECHNIQUE

Under all aseptic & antiseptic precautions spinal anesthesia 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, Injection Levobupivacaine 0.5% 2.5 ml and Injection Fentanyl 25 mcg 0.5ml will be mixed and bolus injection given.

DATA COLLECTION:

Sensory block (with tip of 24 G needle i.e. pin prick method in midclavicular line) 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.

OUTCOME MEASURES:

Primary outcome-

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

Secondary outcome-

Characteristic of motor blockade

Comparison of Hemodynamic stability

Duration of analgesia

Look for any complications