Synopsis DR ABC

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The Controller

Research Training and Monitoring Cell,

College of Physicians and Surgeons, Pakistan,

7th street Phase-II DHA, Karachi 75500

Respected Sir:
Please find enclosed a copy of synopsis titled

“Comparison of Haemodynamic Effects of Unilateral versus Bilateral Spinal Anaesthesia in

Inguinal Hernia Repair”

Prepared by:
Dr. Muhammad Nazir

Postgraduate Trainee

FCPS II Anesthesiology

Submitted on:
RTMC No.: ANS-2017-126-1773

FCPS-I Roll No.: 95017

Name of Supervisor:
Dr. JAWAD ZAHIR

MBBS, FCPS

Professor of Anesthesiology

Head of Department Anesthesiology

Intensive Care & Pain Medicine

Name of Institute:
Holy Family Hospital Rawalpindi

Sign of Head of department:

Supervisor Sign:
Comparison of Haemodynamic Effects of Unilateral versus Bilateral Spinal Anaesthesia
in Inguinal Hernia Repair.

SUPERVISOR:

DR. JAWAD ZAHIR


MBBS, FCPS

Professor

Head of Department Anesthesiology

Intensive Care & Pain Medicine

Holy Family Hospital

Rawalpindi

Dr. Muhammad Nazir


Postgraduate Trainee

FCPS Anesthesiology

Comparison of Haemodynamic Effects of Unilateral versus Bilateral Spinal Anaesthesia


in Inguinal Hernia Repair.
INTRODUCTION:
A special technique of spinal anaesthesia named spinal hemi block was described for one limb
surgeries, which was named as spinal hemianalgesia. This is also known as unilateral spinal
anaesthesia.1 The distance between the left and right spinal roots is only 10-15 millimeter in
the lumbar or lower thoracic level. Such a small distance should reasonably prevent from
producing strictly unilateral block of the spinal nerve roots.2 However, various clinical reports
3-5
suggested that using small doses of either hypo or hyperbaric anesthetic solution injected at
low speeds through directional needles in patients lying in the lateral decubitus position for 10-
15 minutes results in preferential distribution of spinal anaesthesia towards the operated side,
providing intense surgical block on that side. Even though the term unilateral spinal anaesthesia
has been in vogue for a long time most of the research on this are recent. Even though
performing spinal anaesthesia is technically easier, the complications which are usually
expected like hypotension and bradycardia can be detrimental to the high risk group patients.
The haemodynamic changes encountered in spinal anaesthesia are directly related to the extent
of sympathetic block and can be decreased by restricting the block to unilateral sympathetic
chain. Unilateral block is effective in restricting the extent of sympathetic block, hence shows
minimal haemodynamic changes as compared to bilateral block.6 The lack of hypotension, in
particular, makes unilateral spinal anesthesia suitable for patients with cardiovascular risk
factors e. g. aortic valve stenosis or coronary artery disease. Increasing numbers of surgical
procedures are now being performed on an outpatient basis. Until now, spinal anesthesia has
been considered unsuitable for this, not only because of the high incidence of intraoperative
hypotension and postoperative urinary retention but also because of the prolonged
postoperative stay before home discharge. This is not the case with unilateral spinal anesthesia:
motor function returns rapidly, the incidence of urinary retention is extremely low, and patients
are usually eligible for home discharge sooner than after bilateral spinal anesthesia or general
anesthesia. The success of the technique depends on a number of factors. In addition to the
local anesthetic, its concentration and dose, and the baricity of the injected solution, the shape
of the spinal needle, the injection speed, the patient’s position during injection, and the time
the patient remains in this position after injection are equally important parameters.1 Few
studies have been done in the recent past evaluating the hemodynamic stability amongst
bilateral and unilateral subarachnoid block. Ijaz et al reported frequency of hypotension to be
6.7% in unilateral group compared to 60% in bilateral subarachnoid block group . Another
study by Ahmad et al7 reported frequency of hypotension to be 7.7% in unilateral group versus
24.6% in the bilateral subarachnoid group. The difference reported by them was lower
compared to that by Ijaz et al. These contrasting results and the limited number of studies on
the subject led us to compare the hemodynamic stability of patients in patients undergoing
unilateral versus Bilateral spinal anesthesia.
OBJECTIVE:
To Compare the haemodynamic effects of unilateral versus bilateral spinal anaesthesia
in inguinal hernia repair.

OPERATIONAL DEFINITIONS:
Primary Outcome Variables:
Bradycardia: Patients having heart rate < 60 beats per min anytime from the moment of
administration of spinal anesthesia till end of the procedure
Hypotension: A drop in Mean arterial pressure of more than 30% of baseline values anytime
from the moment of administration of spinal anesthesia till the end of the procedure

NULL HYPOTHESIS:
There is no difference in the frequency of hypotension in patients undergoing unilateral spinal
anesthesia as compared to Bilateral spinal anesthesia
ALTERNATE HYPOTHESIS
Frequency of hypotension in patients undergoing Unilateral spinal anesthesia is less as
compared to those undergoing Bilateral anesthesia.
MATERIALS AND METHODS:
Setting: Holy Family Hospital, Rawalpindi.
Study Design: Randomized Control trial.
Sample size:
Using OpenEPI Sample Size calculator with the following:
Confidence level: 95%
Power of test: 80%
Anticipated population proportion 1 : 6.7%
Anticipated population proportion 2 : 60%

Sample size in each group comes to be 12 patients in each group.

SAMPLING TECHNIQUE:Non Probability consecutive sampling.


Duration:6 months after the approval of synopsis.
SAMPLE SELECTION: -
Inclusion criteria:
ASA – I, II
Age: Adults 30 -60 years.(both gender)
Elective surgery (Inguinal Hernia Repair)
Exclusion criteria:
Patient refusal
Haemodynamic instabilty
Patients with Ischaemic herat disease
Infection at the site of injection,
Diseases / injuries of vertebral column
Neurological deficits
History of coagulopathy
Known allergy to local anaesthetic.

DATA COLLECTION PROCEDURE:


After approval from hospital ethical committee, written informed consent will be
taken from the parents,24 patients will be recruited according to above mentioned selection
criteria. All patients will be assessed a day before surgery for anesthesia fitness. Patients will
be prepared by fasting (8 hours for solid foods, 4 hours for clear fluids). Patients will be
randomly divided into two equal groups by computer-generated random numbers.
Group A will receive unilateral spinal anaesthesia.
Group B will receive bilateral spinal anaesthesia.
After arrival in operation theatre, monitoring including echocardiography,
pulse oximeter, non invasive blood pressure will be attached and baseline heart rate and blood
pressure will be noted.Each group will be preloaded with Ringer lactate at the rate of 15 ml/kg
over 10 min.Baseline vitals will be taken. Spinal anaesthesia will be induced in the lateral
position with 25G, Quincke needle at L3-L4 level in group A patients. Under aseptic measures
2 ml of 0.75% hyperbaric bupivacaine will be injected intrathecally after observing clear CSF
flow. Patient will be lying lateral for 10 min and then supine position will be made.
Spinal anaesthesia will be induced in the sitting position with 25G,Quincke needle at L3-L4 in
group B patients.Under aseptic measures ml of 0.75% hyperbaric bupivacaine will be injected
intrathecally after observing clear CSF flow.Patient will be positioned supine and 10 degree
head down to achieve block for surgery.
The level of sensory block in both groups will be assessed by pin prick method in a caudal to
cephalic direction.Motor block will be recorded according to the Bromage scale. Fluid
administration will be continued intraoperatively and a decrease in mean arterial pressure
greater than 20 % below the pre-anaesthetic baseline will be treated with the dose of
Phenylephrine 100 mcg IV. A decrease in heart rate below 50 beats/min will be treated with
dose of atropine 0.01 mg /kg IV.

DATA ANALYSIS:
Data will be collected on a well-structured Proforma and SPSS 22 version will be used
to analyze data.Frequency and percentage will be calculated for Gender, presence of
hypotension,bradycardia . Quantitative variable like age, heart rate and blood pressure will be
measured in terms of mean and standard deviation.Chi square test will be applied to compare
the proportion of hypotension and bradycardia amongst the two groups . Effect modifiers such
as ASA class, reducibility/irreducibility of hernia will be controlled through stratification and
post stratification statistical tests applied.A p value of <0.05 will be taken as statistically
significant.

REFERENCES:
1. Büttner B, Mansur A, Bauer M, Hinz J, Bergmann I. Unilateral spinal anesthesia:
literature review and recommendations. Der Anaesthesist. 2016 Nov;65(11):847-65.
2. Imbelloni LE. Spinal hemianesthesia: Unilateral and posterior. Anesthesia, essays and
researches. 2014 Sep;8(3):270.
3. .Gentili ME, Mamalle JC, Le Foll G. Combination of low dose bupivacaine and
clonidine for unilateral spinal anesthesia in arthroscopy knee surgery. Reg Anesth,
1995; 20: 169-70.
4. Kuusniemi KS, Pihlajamaki KK, Irjala JK, Jaakkola PW, Pitkanen MT, Korkeila JE.
Restricted spinal anaesthesia for ambulatory surgery: a pilot study. Eur J Anaesthesiol,
1999; 16: 2-6.
5. Karacalar S, Türe H, Sarihasan B. Unilateral spinal anesthesia in two centenarian
patients. J Clin Anesth, 2008; 20: 452-4.
6. IJAZ N, ALI K, AFZAL F, AHMAD S. COMPARISON OF HAEMODYNAMIC
EFFECTS OF UNILATERAL VERSUS BILATERAL SPINAL ANAESTHESIA IN
ADULT PATIENTS UNDERGOING INGUINAL HERNIA REPAIR. Biomedica.
2013 Dec 31;29(4).
7. Ahmad H, Sagheer A, Aslam S. Comparison of Haemodynamic effects of Unilateral
versus Bilateral spinal anesthesia in inguinal herniorrhaphy. JUMDC VOL.6, Issue 4,
2015

Performa
GROUP ____________
Gender: ______

Serial No.: ___________

Name: ______________

Hospital registration number: _________

Date of Surgery: _____________


Weight (kg): __________
Age: ____________

ASA Class:

Hernia: Reducible / Irreducible

Height: __________

BMI: _______________

Date of admission: _________

Outcome Variable Yes/ No

Hypotension

Bradycardia

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