| Although
there are many studies comparing the analgesic efficacy of nalbuphine added to
bupivacaine or bupivacaine alone for lower abdominal surgeries, there is no
study comparing the effect of addition of nalbuphine to levobupivacaine or
levobupivacaine alone. So in the present study, we propose to compare the
analgesic efficacy of levobupivacaine with or without nalbuphine in lower
abdominal surgeries.
Aim:
To compare the analgesic efficacy of levobupivacaine with or without nalbuphine
in patients undergoing lower abdominal surgeries under subarachnoid block.
Objectives:
To compare levobupivacaine with or without nalbuphine in patients under
subarachnoid block in terms of:-
Primary objective:
Analgesic efficacy:
1.
Time
of regression of the level of sensory blockade to T12 dermatome.
2.
Duration
of effective analgesia (Time from the subarachnoid block to the time of patient’s
first complaint of pain (VAS ≥ 3).
Secondary objective:
1.
Quality of sensory block.
2.
Quality of motor block.
3.
Side effects like nausea, vomiting,
hypotension, bradycardia, pruritus and any other. Population/participants
Inclusion criteria:
Patients belonging to ASA grade I or II,
between 18-65 years of age, and height 150-180 cm, about to undergo lower
abdominal surgeries under subarachnoid block will be included in the study.
Exclusion criteria:
Patients who do not give consent for
subarachnoid block.
Patients with infection at injection
site.
Patients with coagulopathy.
Patients with space occupying lesion.
Patients with increased intracranial
tension.
Patients with seizure disorder,
pre-existing neurological deficit, any spine deformity.
Patients with hepatic and renal disease.
Patients who are on antiarrhythmics.
Drug addicts and chronic alcoholic.
Sample
size: A minimum of 50 patients (25 in each group) will be
recruited.
From a previous study, time of
regression of sensory block to T12 dermatome with 2.5 ml of 0.5% isobaric levobupivacaine was
139.5±46.9 minutes. Considering the same standard deviation of 46.9 minutes in
levobupivacaine and levobupivacaine with 1 mg nalbuphine group, to estimate a difference of 40 minutes in
time of regression of sensory block to T12 dermatome , at 5% level of significance
and 80% power, 22 cases are required in
each group. Therefore, it was decided to include 25 patients in each group
.They will be randomly allocated in one of the two groups using a computer generated
random number table.
Methods:
Patients
will be randomly allocated to one of the two groups:-
Group-LS
: 12.5 mg of 0.5% isobaric levobupivacaine (2.5 ml)+ normal saline(0.5ml)
Group-LN:
12.5 mg of 0.5% isobaric levobupivacaine (2.5 ml)+ 1 mg nalbuphine(0.1 ml)
+ normal saline(0.4 ml)
The total volume of intrathecal drug
will be 3 ml in both the groups.
Under continuous monitoring, subarachnoid
block will be performed under all aseptic precautions as per the standard
protocol. Patients will be assessed for characteristics of sensory and motor
block, sedation score, haemodynamic parameters, pain score and side effects.
OUTCOME
MEASURES
Primary:
Analgesic efficacy:
1. Time of regression of the level of
sensory blockade to T12 dermatome.
2.
Duration of effective analgesia ( Time from the subarachnoid block to
the time of patient’s first complaint of pain(VAS ³
3).
Secondary:
1.
Quality of sensory block.
2.
Quality of motor block.
3.
Side effects like nausea, vomiting,
hypotension, bradycardia, pruritus and any other.
Statistical
Analysis:
Statistical analysis will be carried out
in SPSS, software version 20.0. The quantitative parameters like age, height,
weight, time of onset of block(when the sensory block is achieved at level of
T10 dermatome) , maximum height of sensory block achieved, time to two segment regression of sensory block
(from the maximum height of
block), time of regression of sensory block to the level of T12
dermatome, duration of effective analgesia( time from giving subarachnoid block
to patient’s first complaint of pain (VAS ≥ 3) and rescue analgesia given to
patient which are measured at one-time point will be compared using
unpaired t-test. Qualitative data like
gender distribution, ASA physical status, quality of muscle relaxation and VAS
score will be analysed using Chi –square test. Repeated measure ANOVA will be
used to compare the haemodynamic variables and sedation score. A p- value <
0.05 will be considered significant.
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