Comparison of low dose spinal Bupivacaine along with Fascia Iliaca block vs conventional dose spinal Bupivacaine along with Fascia Iliaca block in elderly patients undergoing hip surgeries

SUMMARY

Title -Comparison of low dose spinal Bupivacaine along with Fascia Iliaca block and conventional dose spinal Bupivacaine along with Fascia Iliaca block in elderly patients undergoing hip surgeries

Introduction

Hip fracture is a leading cause of morbidity in individuals aged 65 years and older  especially because of their tendency to fall and osteoporotic bone. Displaced femoral neck fractures are usually an indication of early surgical intervention. Spinal anesthesia is a common anesthesia administration for hip arthroplasty due to its advantages over general anaesthesia.

Fascia iliaca compartment block(FICB) is a popular regional technique for surgeries involving hip joint and femur[5]. Local anaesthetic is injected proximally beneath the fascia iliaca with the aim of blocking femoral nerve (FN) ,obturator nerve(ON), and lateral cutaneous nerve of thigh simultaneously. The hip joint receives its sensory supply from FN, ON, articular branches of sciatic nerve, nerve to quadratus femoris and superior gluteal nerve and sensory supply to skin on lateral side of thigh is by lateral cutaneous branch of subcostal nerve. Spinal anaesthesia in conventional doses can lead to haemodynamic instability which may not be tolerated in elderly patients with comorbidities.Reducing the dose of drug for spinal anaesthesia can help decrease the haemodynamic instability but might decrease the duration of action.In this randomised control trial we aim to compare low dose spinal anaesthesia along with FIC block with conventional dose spinal anaesthesia along with FIC block

Aims and objectives

Aim --Comparing low dose spinal anaesthesia and FIC block with conventional dose spinal anaesthesia and FIC block in hip surgeries of elderly patient.

Primary objective

To estimate duration of anaesthesia

Secondary objective

1)To compare mean arterial pressure (MAP), Systolic blood pressure (SBP)and diastolic blood pressure(DBP) at different time interval

2)To estimate duration of analgesia

MATERIAL AND METHODS:

Study design: A prospective randomised double blinded control study

Study duration: the study will be conducted over a period of 12 months after institutional ethics committee approval.

Study site- the study will be conducted on patients under going hip surgeries in the orthopaedic operation theatre

Hospital

Sample Size:66

`Inclusion criteria:

1. Patients undergoing bipolar hemiarthroplasty, total hip arthroplasty, neck of femur fracture, intertrochanteric fracture femur

2. ASA 1-3

3. Age 60-75

Exclusion criteria

1.Patient refusal

2.local infections

3.coagulation abnormalities

4. patients with neurological diseases

5.allergy to study medication

6.raised intracranial pressure

Randomization and blinding

A computer-generated random allocation sequence will be created using SPSS Statistics with a 1 is to 1 allocation and random block size. After providing written informed consent, the participants will be randomized to the L group and C group,using sealed opaque envelopes to reveal the treatment arm on the morning of surgery.The spinal anesthesia will be by anaesthetist not part of the study. The patients or data collectors will not be aware of the grouping. Primary investigator will monitor the patient through out.

METHODOLOGY

All patients will be assessed pre-operatively.

Routine investigations like blood grouping, complete hemogram, chest x-ray, serum creatinine,blood sugars, ECG and other relevant investigations will be done.

On the day of surgery, NBM of 6-8 hours will be confirmed and written informed consent will be obtained and the patient will be taken inside the operation room.

ASA standard monitors will be attached.

Patients will be randomly allocated into two groups.

Group C will receive FIC block and conventional dose spinal anaesthesia Group L will receive FIC block and low dose spinal anaesthesia.

Fascia iliaca block:Under all aseptic precautions in supine postion, transducer will be placed to identify the femoral artery ,fascia iliaca and the iliopsoas muscle. Then the probe will be moved till the sartorius muscle is seen. A skin wheal will be made and then the needle will be inserted through fascia iliaca.When the needle pierces the fascia iliaca a pop will be felt and on USG we maybe able to see the fascia pop back. After negative aspiration, 1–2 mL of local anesthetic will be injected to confirm the proper injection plane between the fascia and the iliopsoas muscle.If local anesthetic spread occurs above the fascia iliaca or within the substance of the muscle itself, additional needle repositions and injections may be necessary. If the injection is administered properly, there will be separation of the fascia iliaca by the local anesthetic in the medial - lateral direction from the point of injection.If there is a proper spread of local anaesthestic, 20 mL 0.5% Ropivacaine will be injected.

After FICB block spinal anaesthesia will be performed in all patients in sitting position. Under aspetic precautions subarachnoid block will be administered using

25G Quincke’s needle. In Group C, 10 mg of Bupivacaine (0.5%) with 25 microgram of Fentanyl will be administered and in Group L, 5 mg of Bupivacaine (0.5%) with 25 microgram of Fentanyl will be administered.After administration of spinal anaesthesia all patients will receive 8 ml per Kg of Ringer Lactate intravenously over 10-15 mins.The level of sensory block will be assessed laterally in anterior axillary line by pin prick method and motor block will be assessed using Modified Bromage scale.

T10 level will be considered adequate for hip surgeries.

Intraoperatively vital parameters which include heart rate, blood pressure,oxygen saturation and temperature will be monitored and noted.Arterial pressure and heart rate will be monitored every 5 mins during the first 30 mins and then at every 10 min interval, If Systolic arterial blood pressure decrease more than 20% below the baseline or less than 90mm of Hg, 5mg of ephedrine will be given intravenously (mean arterial pressure (MAP) below 70 mmHg). Bradycardia (heart rate below 50) will be treated with atropine 0.6mg.

Outcome measurements

Primary outcomes

Duration of anesthesia: The duration of anaesthesia will be from intrathecal bupivacaine injection till the level recedes below T10.

Secondary outcomes

Mean Arterial Pressure, systolic blood pressure,diastolic blood pressure at various interval-

MAP,SBP, and DBP at various time interval i.e. every 5 mins till level recedes below T10 .

Duration of analgesia will be defined as the duration from intrathecal injection of bupivacaine till rescue analgesic is required.rescue analgesic will be given when

VAS score is more than 3

Confidentiality

The participants details will not be disclosed at any point of time. During publication of the data all care will be taken as to not disclose the details of the individual participants

Statistical methods

The normality of the continuous data will be tested using the Shapiro–Wilk test. Normally distributed data will be expressed as a Mean plus or minus SD, while non-normally distributed data will be expressed as a Median .Count data will be expressed as numbers or percentages. The between-group comparison will be performed using an independent t-test for normally distributed measurement data, and the Mann–Whitney U test for non-normally distributed measurement data. For count data, the between-group comparison will be performed using chi-square analysis. P < 0.05 will be considered statistically significant. SPSS 24 software will be used for statistical analysis.