Vol 14, Issue 9, 2021
Online - 2455-3891
Print - 0974-2441
COMPARISON OF INTRATHECAL HYPERBARIC ROPIVACAINE 0.5% WITH AND WITHOUT
75 MG MAGNESIUM SULFATE AS AN ADJUVANT FOR INFRA UMBILICAL SURGERIES: A
DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL
SRINIDHI SRIKANTH, ANTONY JOHN CHARLES S*, YASHA KAMAESHAR, GAYATRI MISHRA
Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth Deemed to be University,
Pillayarkuppam, Puducherry, India. Email: anjocharlie@gmail.com
Received: 20 June 2021, Revised and Accepted: 03 August 2021
ABSTRACT
Objective: Intrathecal magnesium as an adjuvant to hyperbaric ropivacaine could extend duration of sensory blockade and improve the quality of
post-operative analgesia; thereby reducing opioid requirements and its adverse effects. Hence, we conducted this prospective, randomized, double-
blind clinical trial to observe its effects for day care surgeries.
Methods: After obtaining institutional ethical committee approval and registration of trial, patients’ informed consent was taken and eighty adult
patients of either gender, ASA 1 and 2, posted for infra umbilical surgeries were divided into two groups: Group RM received 3 ml hyperbaric
Ropivacaine with 0.75 ml magnesium sulfate (75 mg) and Group R received 3 ml hyperbaric Ropivacaine with 0.75 ml sterile water. Sensory and motor
blockade parameters, hemodynamic variables, and adverse effects were monitored, analyzed using appropriate statistical tests.
Results: Total duration of sensory blockade was significantly prolonged in Group RM compared to Group R (242.8 ± 9.9 versus 186.6 ± 8.4 min)
(***p<0.001). Complete motor regression was observed significantly earlier in Group RM than in Group R (151.3 ± 7.8 versus 184.7 ± 5.6 min) (*p<0.05).
Post-operative pain free interval was significantly prolonged in group RM compared to group R (725.2 ± 18.6 vs. 515.2 ± 17.8 min) (***p<0.001).
Conclusion: We concluded that intrathecal magnesium as an adjuvant to hyperbaric Ropivacaine significantly prolonged both sensory blockade
duration, post-operative pain-free interval without increasing motor blockade duration and the incidence of adverse effects.
Keywords: Intrathecal magnesium sulfate, Intrathecal hyperbaric ropivacaine, Day care anesthesia.
INTRODUCTION
Spinal anesthesia is a preferred technique for day-care orthopedic,
gynecological, and lower abdominal surgical procedures [1].
Lignocaine was commonly used due to its short duration of action
but reports of transient radicular irritation led to decline in its
use [2]. Intrathecal Ropivacaine offers shorter motor blockade
duration hence, encouraging early mobilization in patients [3-5]. Due
to difficulty in maintaining pharmacological stability of hyperbaric
Ropivacaine, presently only isobaric solution is available. But
Ropivacaine, made hyperbaric with Dextrose, had produced more
consistent block, prolonged the needed duration with quicker
complete regression [6,7].
Opioid adjuvants have been used with intrathecal Ropivacaine for
extending the duration of block and their side effects such as nausea,
vomiting, pruritus, and sedation have been noted [8,9]. Intrathecal
magnesium has been used in humans since 1906 [10,11].
Comparison of hyperbaric Ropivacaine, which is emerging as local
anesthetic of choice for spinal anesthesia in day care surgery [2] with
and without magnesium sulfate alone; is elucidated in fewer studies.
Hence, we conducted this randomized trial to demonstrate its effects
as an adjuvant to intrathecal hyperbaric Ropivacaine for day care infra
umbilical surgeries by monitoring block characteristics, hemodynamic
parameters, and adverse effects.
METHODS
This present prospective, randomized, and double-blind clinical trial
was conducted in a tertiary care teaching hospital from January 2019 to
June 2020 after obtaining Institutional Ethics Committee approval and
registration in Clinical Trials Registry of India.
80 adult patients (18–60 years) of either gender, American Society
of Anesthesiologists Grade 1 and 2, posted for infra umbilical
procedures under orthopedics, gynecology, urological, and general
surgeries of approximately 2-h duration were included in the study.
Patients unwilling to participate, pregnant and breast-feeding mothers,
patients with spinal deformity, instrumentation or any contraindications
for spinal anesthesia and patients with major cardiac, neurological, and
respiratory illness were excluded from the study.
Selected patients underwent pre-anesthetic checkup and were
informed about the aim of our study, familiarized with visual analogue
scale (VAS) (0 – no pain to 10 – worst ever imaginable pain) in their
local language, and a written informed consent was taken after ensuring
their willingness to participate in the study.
Patients were kept Nil by mouth from 10 pm the day before surgery.
Tablet Ranitidine 150 mg, Tablet Metoclopromide 10 mg, and
Tablet Alprazolam 0.25 mg were given with sips of water on the
night before and at 7 am on the morning of surgery. After taking
patient inside the operation theatre, monitors were attached and
baseline electrocardiogram, blood pressure, and SpO2 were noted.
A wide bore intravenous (IV) line was secured with 18Gauge (G) IV
cannula, and the fluid Ringer lactate infused at the rate of 10 ml/kg/h.
Patients were selected through simple random sampling using
computer generated numbers and group allocation was done through
sealed envelope technique. Patients were divided into two groups:
© 2021 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.org/
licenses/by/4.0/) DOI: http://dx.doi.org/10.22159/ajpcr.2021v14i9.42497. Journal homepage: https://innovareacademics.in/journals/index.php/ajpcr
Research Article