Post-operative Pain Clinical Trial
Official title:
Effect of Intravenous Lidocaine on Immediate Post-operative Pain, Nausea and Vomiting in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Placebo Controlled Trial
Lidocaine is a drug that has multiple uses. One of these is that when intravenously administered it is effective in reducing post-operative pain. The aim of this study is to investigate the beneficial effects of intravenous lignocaine on reducing pain, nausea and vomiting after laparoscopic cholecystectomy. Also, by this research, we are aiming to find a suitable alternative analgesic.
After approval of synopsis from College of Physician and Surgeons of Pakistan (CPSP) and
Ethical review committee (ERC) of Aga Khan University Karachi, patients fulfilling the
inclusion criteria will be enrolled in the study. Written informed consent will be obtained
before the surgery. Patients will be randomly allocated by CTU through computer generated
block randomization into either lidocaine group (LG) or placebo group (PG).
The clinical trial unit (CTU) will be responsible to prepare the study drug and placebo in
the same volume, color, consistency and packaging and treatment allocation would be done by
assigning the study drug and placebo numbers. The staff, patient and the anaesthetists will
be blind by the drug allocation. Only the CTU will have the list of randomization and their
treatment allocation.
All patient will be given general anesthesia as per standard of care. All patients will be
pre-medicated with oral midazolam 7.5 mg one hour before operating room. Standard American
Society of Anaesthesiologists (ASA) monitoring (NIBP, ECG, and Pulse Oximetry) will be
applied. General anesthesia will be induced by Propofol 2 mg/kg, Nalbuphine 0.1mg/kg and
Cis-Atracurium 0.2 mg/kg. Isoflurane 1% - 1.5% in a mixture of oxygen and air (50:50) will be
used for maintenance of anesthesia. Before tracheal intubation, patients will receive
intravenous bolus injection of the study drug in dose of 1.5mg/kg followed by the continuous
infusion at the rate of 1.5mg/kg/hr. via standard computerized programmable infusion pump.
The infusion will be continued throughout the surgery and will be stopped after extubation.
After intubation, patients' minute ventilation will be adjusted to maintain normocapnia (end
tidal CO2 35 - 40 mm of Hg). All patients will be given 1gm of intravenous Paracetamol after
induction of anaesthesia. Supplemental analgesia, Nalbuphine 1mg, during surgery will be
given if the heart rate and systolic blood pressure increases above 20% of respective
baseline values and causes other than pain had been ruled out, which would be at the
discretion of the primary anaesthetist. Prophylaxis for nausea and vomiting will be given by
Dexamethasone 0.1mg/kg at induction of anaesthesia and Ondansetron 0.1mg/kg after the removal
of gall bladder. At the end of surgery, residual neuromuscular blockade will be reversed by
0.05mg/kg of neostigmine and 0.5mg of glycopyrolate. The trachea will be extubated once the
patient regained consciousness and then transferred to the post anesthesia care unit (PACU).
In the PACU, each patient will be assessed by the primary investigator for pain, nausea and
vomiting at 15, 30, and 60 minutes. If the patient's pain will be equal to 4 or more on the
numerical rating scale, he/she will be given Nalbuphine 1mg as a rescue analgesic. Likewise,
if the patients has complain of nausea or vomiting, equal to or greater than 2 on Bellvile
nausea score, he/she will be given Metoclopramide 10mg as rescue antiemetic. The analgesic
and anti-emetic requirement in the ward for the first 6 hr. post-operatively will be recorded
by the primary investigator.
The time of arrival at PACU will be recorded as "T1". The discharge time from PACU will also
be recorded and would be declared as "T2". The time required for the patient to be discharged
from the hospital will be recorded as "TD". TD will be the time when surgical team decides
that patient can be discharged from the hospital. The difference between the length of stay
in the hospital between the two groups will be calculated as total time spent (in HOURS) in
the hospital "TT". It will be the sum of time interval between T1 to T2, and T2 to TD.
TT= (T1+T2+TD)
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