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6.
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
The International Association for the Study of Pain defines pain as “an
unpleasant sensory and emotional experience associated with actual or potential
tissue damage or described in terms of such damage”.
In case of postoperative pain the cause is tissue injury. Untreated postoperative
pain can lead to some of the acute effects like sympathetic nervous system activation
and neuroendocrine stress response resulting in increased morbidity and mortality. It
is also an important predictive factor in the development of long term chronic pain.
The goal of postoperative pain management is to reduce or eliminate pain and
discomfort with minimum side effects. There are many methods to control pain, of
which opioid analgesics are one of the corner stone option in the management of
pain. However opioid drugs differ from each other with respect to efficacy, potency,
sedation and side effects. Tramadol is an weak opioid agonist. It also inhibit the
reuptake of the serotonin and norepinephrine and used in mild to moderate pain
relief. Nalbuphine is a newer opioid drug with antagonism at μ receptor and
agonism at
κ receptor. Hence my study is selected to compare the efficacy and side
effects of these two drugs.
6.2 Review of Literature:
In a study of 40 patients posted for abdominal hysterectomy, 20 patients
received intravenous bolus nalbuphine followed by continuous infusion. The other
20 received intravenous bolus tramadol followed by continuous infusion. They
concluded that more supplemental analgesia was required in the tramadol group and
general well being was better in the nalbuphine group.1
In a study of 24 children aged 1-10 years undergoing scheduled surgical
procedure, half of them received intravenous bolus dose of nalbuphine followed by
infusion and the other half received intravenous bolus dose of tramadol followed
by infusion, both for a duration of 72 hr. Sedation was more in the nalbuphine
group whereas vomiting was more in tramadol group. The requirement of extra
bolus dose was three times more frequent in the nalbuphine group compared to
tramadol group. 2
A study was conducted on 56 postoperative patients to compare the relative
analgesic potency of intramuscular nalbuphine and morphine. It was concluded that
nalbuphine was 0.8 to 0.9 times as potent as morphine with no psychomimetic
reactions which is more common with morphine.3
In a study on 80 patients posted for elective hip and knee arthroplasty to assess
the clinical efficacy of tramadol and morphine using PCA delivery system, it was
concluded patient satisfaction was more with morphine. Nausea and vomiting was
more with tramadol. Morphine produced more sleepiness.4
In a study of 126 patient under going abdominal hysterectomy the analgesic
effectiveness and side effects of intravenous patient controlled morphine,pethidine
and tramadol were compared. All the three drug have equivalent pain scores and
side effects but tramadol group required more frequent use of rescue analgesic.5
In another study comparing nalbuphine hydrochloride with pethidine after
elective orthopaedic surgery, both drugs were given intramuscularly on the first day
postoperatively. It was observed that nalbuphine had a longer duration of action
whereas pethidine had more respiratory depressant action.6
6.3 Objectives of the study:
1. To compare the analgesic efficacy of tramadol with nalbuphine in the
postoperative period.
2. To compare the propensity to cause sedation between tramadol and
nalbuphine.
3. To determine the occurrence of adverse effects with tramadol and nalbuphine.
7.
Materials and Methods:
7.1 Source of Data:
Patients aged between 35-60 years, ASAgrade 1-3 posted for lower abdominal
surgeries under subarachnoid block in A. J. Hospital, Mangalore between september
2009 and september 2010.
7.2 Method of the Collection of the Data (Including sampling procedures
if any) :
50 patients aged between 35-60 years posted for lower abdominal surgeries were
divided in to two groups (Group N & Group T) on the basis of random sampling
method.
Group N will receive 0.1mg/kg body weight of nalbuphine intravenously when
pain is complained of postoperatively and repeated every 6th hourly for 24hours.
Group T will receive 1mg/kg body weight of tramadol intravenously when pain
is complained of postoperatively and repeated every 6th hourly for 24hours.
The same analgesic is to be repeated intravenously, half the dosage for breakthrough
pain.
Inclusion criteria:
Fifty patients of ASAgrade 1-3 between the age group of 35-60 yr posted for
lower abdominal surgeries.
Exclusion criteria:
1. Patients allergic to the study drugs.
2.Patients on

oral anticoagulant therapy

neuroleptic agent

MAO inhibitor
3. Patients with

History of epilepsy

Increased intracranial tension

History of motion sickness

History of opioid use over the last 1 month
Parameters to be studied:
1) Analgesic efficacy of study drugs as evidenced by Visual Analogue
Scale and Verbal Category Scale at 30 minutes, 3 hours, 6 hours after
each dose over the first 24 hours postoperatively.
2) Sedation score at 30minunes, 3hours, 6hours after each dose over the
first 24 hours postoperatively
3) Vitals of the patient i.e pulse rate, blood pressure, respiratory rate and
peripheral oxygen saturation hourly over the first 24 hours
postoperatively.
7.3 Does the study require any investigations or interventions to be
conducted on patients or other humans or animals? If so, please describe
briefly.
Yes, routine investigations namely complete haemogram, E.C.G, urine
analysis, blood sugar, renal function tests have to be done.
8.
List of References:
1) Alon E, Atanassoff PG, Biro P.Intravenous postoperative pain management
using nalbuphine and tramadol. Anaesthesist 1992 Feb;41(2):83-87
2) Moyao-Garcia D, Hernandaz-Palacios JC, Ramfrez-Mora JC, . Nava-ocampa AA. A pilot
study of nalbuphine versus tramadol administered through continuous
intravenous infusion for postoperative pain control in children.Acta Biomed.
2009 ;84 :124-130.
3) Beaver WT, Feise GA. A comparison of the analgesic effect of intramuscular
nalbuphine and morphine in patient with postoperative pain. Pharmacology
and Experimental Therapeutics.1978;204(2):487-496.
4) Pang WW, Mok MS, Lin CH, Huang MH. Comparison of patient controlled
analgesia with tramadol or morphine.Can J Anesth 1999;46(11): 1030-1035.
5) Unlugene H, Vardar MA, Tetiker S. A Comparitive study of the analgesic
effect of patient controlled morphine, pethidine, and tramadol for
postoperative pain management after abdominal hysterectomy. Anesth Analg
2008; 106:309-312.
6) Brock – Utne J.G, Ritchie P, .Downing J.W. A comparison of nalbuphine and
pethidine for post operative pain relief after orthopaedic surgery.S Afr Med J
1985; 68:391-393.