CE (Ra1) F (SL) PF1 (AB SL) PN (SL)
CE (Ra1) F (SL) PF1 (AB SL) PN (SL)
CE (Ra1) F (SL) PF1 (AB SL) PN (SL)
12348
Original Article
the eligibility criteria (ASA physical status I and II, Mallampati grade I N2O in O2 and isoflurane up to 1.5 MAC (under guidance of BIS
and II) were counselled regarding the study and those who gave the monitoring). On completion of modified radical mastectomy,
consent were included in the study. inj. glycopyrrolate 0.01 mg/kg and inj. neostigmine 0.05 mg/kg
Exclusion criteria were patients with known allergic to ropivacaine, was used for reversal of anaesthesia and extubation was done
magnesium sulphate; hepatorenal or cardiopulmonary abnormalities, with adequate spontaneous ventilation with Train-of-Four (TOF)
alcohol addict or diabetes, neuropsychiatric or neuromuscular ratio>0.9 and BIS≥70. Ten minutes after extubation, patients
disorders, thrombocytopenia, coagulation or seizure disorders, were all transferred to Post Anaesthesia Care Unit (PACU) for
observation and postoperative pain management.
anatomical anomalies of thoracic spine.
Insufficient analgesia was reflected by the presence of hypertension
The patients were randomised using computer generated
or tachycardia (>20% of baseline) during anaesthesia, {while BIS
random number list and group allocation was done using
was 40-60 (i.e., within desired range)} and fentanyl 1 µg/kg was
sealed envelopes. These opaque envelopes had a paper slip
used to treat the condition. Propofol was supplemented with
inside them indicating either RM or RP group. On the outside
0.2 mg/kg bolus for maximum three successive boluses at an
patient’s registration number was mentioned. When the patient
interval of three to five minutes. This bolus propofol was given when
was received in the OT complex, the numbered envelope was
BIS value exceeds 70. Target BIS was 40-60.
handed over to a resident anaesthesiologist who was not taking
part in the study. He opened the envelope and prepared the drug Hospital discharge (eye opening-discharge from hospital), the time
mixture to be administered in the TPVB route. Patients in group for PACU stay (means time of arrival in PACU to discharge from
RP received 19 mL of 0.5% ropivacaine+1 mL normal saline for PACU) and also the incidence of adverse events were noted. Modified
Aldrete score is based on Consciousness, Respiration (breathing),
TPVB. Group RM received 19 mL 0.5% ropivacaine+500 mg (1
Oxygen saturation, Circulation (BP), Activity. Each parameter has
mL 50% w/v magnesium sulphate) magnesium sulphate for the
score (0-2). The highest cumulative score is 10. Patients were
same block.
considered ready for discharge from the PACU when the modified
In group RP, 19 mL Ropivacaine (0.5%) {Ropin® 0.5%, NEON Aldrete post anaesthesia score was ≥9. After being discharged from
Laboratories Ltd., Mumbai, India} and 1 mL normal saline mixture PACU patients were transferred to the ward. Ondansetron 0.1 mg/
was prepared. In group RM, 19 mL Ropivacaine (0.5%) and 1 mL kg IV was administered for nausea and vomiting. Same surgeon
magnesium sulphate {Magneon® 50% w/v, NEON Laboratories operated all the cases. Vital parameters recording were done every
Ltd., Thane, Maharashtra, India} mixture was prepared. 10 minutes for first two hour, then every half hourly for 12 hour, then
In all cases, preoperative fasting of minimum six hours was ensured every four hourly for two days.
before operation. All patients were given tablet lorazepam 1 mg After operation, efficacy of the paravertebral block was the
and pantoprazole 40 mg orally at the night before surgery as primary outcome of the study which was measured by time of
premedication. rescue analgesic administration among both the groups. The
All baseline parameters like heart rate, Systolic BP (SBP), Diastolic time of administration of first dose of rescue analgesic (Injection
BP (DBP), Mean Arterial BP (MAP), End tidal CO2 (EtCO2) and paracetamol 1000 mg i.v) following performance of paravertebral
Oxygen saturation (SpO2) were noted in the observation room. block was taken as the duration of block. Visual analog scale
Then all patients were transferred to operation theatre and (VAS; 0=“no pain” and 10=“worst possible pain”) was used to
continuously monitored using multipara monitor. In sitting position, assess the magnitude of postoperative pain for 48 hours. Injection
same technique was used for paravertebral block in every patient. paracetamol was given as rescue analgesia if the pain VAS >3.
2% lignocaine was used for skin infiltration at 2.5 cm lateral to Perioperative adverse reactions and haemodynamic changes
the spinous process of third, fourth and fifth thoracic vertebra. were also observed. Sedation was drowsy (not awake) and non-
Through the skin wheal, Tuohy needle (17G) was inserted till it communicative state (spontaneously, but responded when asked
comes in contact with transverse process of the intended thoracic for). Bradycardia was fall in Heart Rate (HR) ≥20% of baseline HR
vertebras. Tuohy needle was then walked off the cephalad edge or HR <60/min or whichever is greater. When HR was <50/min,
of the transverse process and it was further advanced till it enters 0.6 mg i.v atropine was given. Hypotension was fall in Systolic
in paravertebral space which was identified by loss of resistance Blood Pressure (SBP) ≥20% of baseline SBP or SBP<100 mm
technique by using air. Local anaesthetic mixture which was Hg or whichever is greater. When SBP <90 mm of Hg, 5 mg i.v
already prepared by resident doctor (drawn in identical looking mephentermine was given.
syringes) was injected in the desired position. The anaesthesiologist
performing the paravertebral block was completely unaware STATISTICAL ANALYSIS
of the group allocation or composition of the local anaesthetic Sample size was based on a crossover pilot study of 10 patients
mixture. Data collection was done by another resident doctor. The and was selected to detect a projected difference of 10% time
mixture was injected in three spaces in a divided manner in small (i.e., 1.2 hour) for administration of rescue analgesic among two
aliquots with repeated aspiration. This local anaesthetic mixture groups for a type 1 error of 0.05 and a power of 0.8. On the basis
administration was followed by general anaesthesia administration of our previous study assuming within group SD of six hour and
in supine position. we needed to study at least 36 patients per group to be able to
Normal Saline (NS) was started via 18 G i.v cannula done prior to reject the null hypothesis which will be increased to 40 patients
transport of patient to OT. Pre-oxygenation was done with 100% O2 for possible dropouts. Raw data were entered into a MS Excel
for five minutes. Premedication was given with inj. Glycopyrrolate spreadsheet and analysed using standard statistical software SPSS®
(0.2 mg), inj. fentanyl (100 µg), inj ondansetron (8 mg) three statistical package version 18.0 (SPSS Inc., Chicago, IL, USA).
minute before induction. Propofol (2 mg/kg) was used as inducing Categorical variables were analysed using the Pearson’s chi-square
agent. Then laryngoscopy and intubation was done with the test. Normally distributed continuous variables were analysed using
help of atracurium (0.5 mg/kg). After three minutes of atracurium the independent sample t-test and p-value <0.05 was considered
application, less than 20 seconds were taken for laryngoscopy, statistically significant.
intubation, and cuff inflation in all cases. Intraoperative muscle
relaxation was maintained with intermittent intravenous atracurium RESULTS
(0.2 mg/kg) as per requirement. Anaesthesia workstation was Each breast cancer surgery group in our study consisted of
used for controlled ventilation which was maintained with 66% 40 patients which was greater than the calculated sample size. As
2 Journal of Clinical and Diagnostic Research. 2018 Dec, Vol-12(12): UC01-UC05
www.jcdr.net Sandip RoyBasunia et al., Magnesium as Adjuvent in Thoracic Paravertebral Block
the dropout cases were nil, 40 patients were in the control group ipsilateral shoulder movement and here also pain was significantly
(RP) and 40 patients in the magnesium group (RM) were considered low (p<0.05) at 4,6,10 and 12 hours after surgery in magnesium
for effectiveness analysis. group [Table/Fig-6].
From [Table/Fig-1] it is evident that age, body weight, Side effects such as sedation, bradycardia, hypotension,
preoperative haemoglobin level, operative and anaesthetic dry mouth, nausea were all comparable among two groups
duration were all found to be comparable (p>0.05). PACU (p>0.05) [Table/Fig-7]. MAP and HR were found to be
discharge time was comparable among two groups [Table/ quite comparable among two groups (p>0.05) [Table/Fig-
Fig-1]. Baseline heart rate and Mean arterial pressure were 8,9] respectively. The participant flow diagram is shown in
also quite comparable among two groups [Table/Fig-1]. [Table/ [Table/Fig-10].
Fig-2] shows types of different breast surgeries and they were
Postoperative Group RP Group RM 95% confidence
comparable too. Intraoperative mean fentanyl and propofol p-value
Period (Hours) (n=40) (n=40) interval
requirement were compared among two groups and they were VAS0.5 2.25±0.52 2.02±0.61 0.0734 0.0223 to 0.4823
much less in amount and statistically significant (p<0.05) in VAS1 2.35±0.55 2.17±0.42 0.1040 0.0378 to 0.3978
group RM than RP [Table/Fig-3].
VAS2 2.91±0.60 2.70±0.51 0.0957 -0.0379 to 0.4579
Demographic Group RP Group RM 95% confidence VAS4 3.18±0.70 2.89±0.59 0.0486 0.0018 to 0.5782
p-value
factors (n=40) (n=40) interval
VAS6 3.52±0.80 3.10±0.72 0.0158 0.0812 to 0.7588
Age (years) 48.11±5.60 50.55±6.30 0.0710 -5.0933 to 0.2133 VAS10 3.73±0.91 3.33±0.82 0.0422 0.0144 to 0.7856
Weight (kg) 60.54±9.33 56.92±10.02 0.3552 -0.6897 to 7.9297 VAS12 3.84±1.04 3.39±0.89 0.0409 0.0191 to 0.8809
Haemoglobin (gm%) 11.82±3.6 12.55±3.91 0.3877 -2.4030 to 0.9430 VAS16 3.92±1.43 3.74±0.94 0.5079 -0.3587 to 0.7187
Duration of Surgery 55.93±8.03 59.11±11.13 0.1468 -7.5002 to 1.1402 VAS24 3.82±1.22 3.49±0.83 0.1612 -0.1345 to 0.7945
Duration of Anaesthesia 70.23±11.21 73.11±10.93 0.2482 -7.8084 to 2.0484 VAS36 3.20±0.78 2.89±0.72 0.0685 -0.0241 to 0.6441
Time to reach Aldrete VAS48 2.88±0.78 2.61±0.48 0.0660 -0.0183 to 0.5583
55.02±8.94 58.92±9.10 0.0568 -7.9156 to 0.1156
score ≥9 (minute)
[Table/Fig-5]: Pain score (VAS) at rest in postoperative period.
Baseline Heart rate 68.55±12.43 63.72±11.93 0.0801 -0.5933 to 10.2533
Baseline MAP 79.34±10.55 76.41±9.09 0.1872 -1.4536 to 7.3136 Postoperative Group RP Group RM 95% confidence
p-value
[Table/Fig-1]: Demographic profile and the preoperative hematologic status in Period (Hours) (n=40) (n=40) interval
both groups. VAS0.5 2.68±0.78 2.37±0.81 0.0852 -0.0440 to 0.6640
VAS1 2.70±0.66 2.45±0.53 0.0655 -0.0165 to 0.5165
Group RP Group RM
Types of Surgery in Breast CA p-value VAS2 3.08±0.68 2.85±0.57 0.1052 -0.0493 to 0.5093
(n=40) (n=40)
Simple Mastectomy (SM) 8 (20%) 10 (25%) p=0.604 VAS4 4.15±0.47 3.70±0.76 0.0021 0.1687 to 0.7313
Modified Radical Mastectomy (MRM) 22 (55%) 20 (50%) p=0.7470 VAS6 4.8±0.60 4.45±0.56 0.0086 0.0916 to 0.6084
Partial/Segmental Mastectomy (PM) 7 (17.5%) 8 (20%) VAS10 5.03±0.71 4.62±0.59 0.0063 0.1194 to 0.7006
[Table/Fig-2]: Types of Surgery in Breast CA for randomised patient groups. VAS16 5.15±0.74 4.89±0.59 0.0862 -0.0379 to 0.5579
Data are presented as n (%).
VAS24 4.81±0.73 4.55±0.51 0.0686 -0.0203 to 0.5403
VAS36 4.17±0.34 3.92±0.46 0.7844 -1.5633 to 2.0633
Group RP Group RM 95% confidence
p-value
(n=40) (n=40) interval VAS48 3.30±0.43 3.52±0.47 0.8304 -2.2577 to 1.8177
Intraoperative -25.2320 to [Table/Fig-6]: Pain on shoulder (ipsilateral) movement in postoperative period.
153.86±25.35 138.49±18.41 0.0027
fentanyl requirement -5.5080
Intraoperative 8.5033 to Group RP Group RM
150.34±18.93 134.23±15.02 0.0001 Parameters p-value
Propofol requirement 23.7167 (n=40) (n=40)
[Table/Fig-3]: Intraoperative fentanyl requirement. Nausea/Vomiting 14 10 0.1441
Sedation 10 12 0.4901
Magnesium group (group RM) received much less paracetamol
(1 gm I.V) than control group (group RP) as rescue analgesic [Table/ Bradycardia (HR <60 bpm) 7 6 0.6570
Fig-4]. The time of administration of rescue analgesic was much Hypotension (SBP <100 mm Hg) 7 6 0.3271
later in group RM than RP. Both the above mentioned results were Dry mouth 5 3 0.2299
statistically significant. [Table/Fig-7]: Side effects.
For detection of pain, VAS score was used at different time interval.
It was significantly low at rest (p<0.05) at 4,6,10 and 12 hours
after surgery with a better pain control in group RM patients than
in group RP patients [Table/Fig-5]. Pain was also assessed with [Table/Fig-8]: Comparison of mean arterial pressure between two groups.
PARTICULARS OF CONTRIBUTORS:
1. Assistant Professor, Department of Anaesthesiology, Midnapore Medical College, Midnapore, West Bengal, India.
2. Associate Professor, Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.
3. Assistant Professor, Department of Anaesthesiology, Murshidabad Medical College, Berhampore, West Bengal, India.
4. R.M.O cum Clinical Tutor, Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.
5. Assistant Professor, Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.
6. Assistant Professor, Department of Anaesthesiology, N.R.S Medical College, Kolkata, West Bengal, India.
7. Associate Professor, Department of Anaesthesiology, I.P.G.M.E & R, Kolkata, West Bengal, India.
8. Professor, Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, Kolkata, West Bengal, India.