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Comparative Study of Epidural Tramadol
v/s Bupivacaine for Postoperative Analgesia Using Disposable Non-Mechanical
Elastomeric Balloon Pump Prerana Shroff*,
Preeti Ahuja**, Shravani Chandra***, L Chaudhari**** |
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Continuous epidural administration of
local anaesthetics and opioids has largely solved the problem
of postoperative pain. The efficacy of epidurally administered
tramadol hydrochloride, as bolus or infusion was studied in
comparison with bupivacaine infusion using disposable, non-mechanical,
elastomeric balloon pump. It can deliver accurate amount of
drug over affixed period. After filling, it runs for 25 hours
continuously without any need for interference and hence there
are least chances of infection.
90 ASA I and II patients undergoing lower limb orthopaedic
surgery were randomized to 3 groups. In group A tramadol was
given as a bolus in the dose of 2 mg/kg in 10 ml NS 8 hourly
for 50 hours, while in group B tramadol infusion in a concentration
of 2-2.5 mg/ml (5 ml/hr) was given for 50 hours. In group C
0.125% bupivacaine infusion (5 ml/hr) was given for 50 hours.
VAS was used to analyze analgesia.
Group C showed better analgesia score as compared to
group B or A, while Group B showed significantly more side effects
like nausea, vomiting as compared to group A or C. 0.125% bupivacaine
infusion showed better analgesia than tramadol bolus or infusion.
Local anaesthetic infusion via an elastomeric balloon
pump can provide good analgesia without significant respiratory
depression or haemodynamic alteration and nausea/vomiting. |
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| INTRODUCTION |
Management of postoperative pain is one of the most
challenging and gratifying domains of anaesthesia. Use
of epidural blockade has increased steadily in popularity
for the management of moderate to severe pain following
orthopaedic surgery. However, the cost and complexity
of managing epidural infusion postoperatively in the wards
or at home is a major disadvantage. Relatively inexpensive
disposable non-mechanical elastomeric balloon pump, not
requiring much intervention make epidural infusion easy
to manage and has revolutionized pain management. In our
study we compared tramadol bolus and infusion with bupivacaine
infusion using elastomeric balloon pump.
A disposable non-mechanical elastomeric balloon pump
was used for the infusion cases. It consists of two-layers
of elastic membrane; the inner layer is composed of a
special blend polymer with a latex outer layer. The two
membranes have an outer cover of soft PVC as additional
protection. The latex outer layer at no time comes into
contact with the infusion fluid. It has an extension line
with one-way filling valve, clamp, and filter for air
and particulate matter. After filling it runs for continuously
without any need for interference. It is easy to manage
and portable. As it is non-programmable it is possible
to use at home. It is relatively inexpensive. |
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| Aim |
| To compare analgesia and adverse effects of continuous
and bolus epidural tramadol versus continuous epidural infusion
of bupivacaine using an elastomeric balloon pump in patients
undergoing lower limb orthopaedic surgery. |
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| Material and Methods |
After appropriate institutional ethics committee approval
90 ASA I and II patients undergoing lower limb surgery
between the age group 21-60 years and weighing 35-79 kg
were studied in a prospective randomized comparative study.
After routine preoperative assessment and investigations,
patients were explained the anaesthesia procedure and
an informed consent was taken. Patients with a history
of hepatic, renal or circulatory disorders, drug allergy,
chronic headache, backache, neurological deficit or pregnancy
were excluded from the study.
Three groups were : Group A : Tramadol bolus 2 mg/kg
in 10 ml NS 8 hourly for 50 hours. Group B : Tramadol
infusion 2-2.5 mg/ml (5 ml/hr) for 50 hours. Group C :
Bupivacaine infusion 0.125% (5 ml/hr) for 50 hours.
Age, weight and preoperative vital parameters were noted.
All patients received 0.6 mg of Inj. Glycopyrolate IM
30 minutes prior to administration of anaesthesia. They
were preloaded with 500 ml of ringer lactate. With due
aseptic precautions CSE technique was used using 16G set.
15-20 mg of 0.5% heavy bupivacaine was used to give sub-arachnoid
block and when level receded below T10, epidural infusion
of 0.375% bupivacaine was started. It was continued till
the end of surgery. Postoperatively one of the 3 modalities
of analgesia was randomly selected and the patient was
shifted to the recovery room. VAS was monitored and adverse
effects were looked for and appropriately treated. Patients
were monitored every 30 minutes for first 4 hours and
then 2 hourly for 50 hours. Patients were asked to grade
pain on a scale of 0-10 points where 0 was no pain and
10 was worst pain. Rescue analgesia in the form of IM
diclofenac (1.5 mg/kg) was given when VAS was ³ 5.
| VAS |
Analgesia |
Pain Relief |
| 19-9 |
None |
0-20% |
| 8-7 |
Slight |
20-40% |
| 6-5 |
Moderate |
40-60% |
| 4-3 |
Good |
60-80% |
| 2-0 |
Complete |
80-100% |
Adverse effects like nausea, vomiting, pruritus, headache,
respiratory depression, abdominal distension, paraesthesia,
and motor weakness were looked for and appropriately treated.
Unpaired students ‘t’ test was used to analyze
numerical data while Chi-square test was used for categorical
data. P < 0.05 was considered as significant (*). |
| Results |
| Table 1 : Demographic
data |
| |
0 HrGroup
A
(Mean ± SD) |
Group
B
(Mean ± SD) |
Group
C
(Mean ± SD) |
| Age (yrs) |
51.28 ± 14.26 |
49.85 ± 13.04 |
54.39 ± 9.96 |
| Weight (kg) |
58.72 ± 9.39 56.48 |
± 11.85 61.56 |
± 10.24 |
| Gender Male |
18 |
20 |
17 |
| Female |
12 |
10 |
13 |
| Total |
30 |
30 |
30 |
| |
| Interval |
Group A
(Mean ± SD) |
Group B
(Mean ± SD) |
Group C
(Mean ± SD) |
| 0 Hr |
0 |
0 |
0 |
| 2 Hr |
0 |
0 |
0 |
| 4 Hr |
2.29 ± 0.76 |
1.60 ± 0.71 |
1.48 ± 0.59 |
| 6 Hrs* |
5.58 ± 1.86 |
3.24 ± 2.40 |
1.28 ± 0.64 |
| 8 Hrs* |
6.28 ± 2.40 |
2.42 ± 0.88 |
1.09 ± 0.76 |
| 10 Hr |
2.03 ± 1.48 |
2.12 ± 0.98 |
1.28 ± 0.71 |
| 12 Hrs |
2.69 ± 1.58 |
2.03 ± 0.82 |
1.68 ± 0.75 |
| 14 Hrs |
4.28 ± 2.05 |
1.98 ± 0.77 |
1.54 ± 0.96 |
| 16 Hrs* |
7.30 ± 3.44 |
2.24 ± 1.20 |
1.36 ± 0.58 |
| 18 Hrs |
1.98 ± 0.88 |
16 ± 0.85 |
1.82 ± 0.67 |
| 20 Hrs |
2.42 ± 1.02 |
3.46 ± 1.16 |
2.02 ± 0.98 |
| 22 Hrs |
2.42 ± 1.02 |
3.46 ± 1.16 |
2.02 ± 0.98 |
| 24 Hrs* |
5.82 ± 2.68 |
4.98 ± 1.77 |
3.65 ± 1.65 |
| 26 Hrs |
0.98 ± 0.42 |
1.02 ± 0.57 |
0.52 ± 0.21 |
| 28 Hrs |
2.17 ± 0.76 |
1.46 ± 0.83 |
1.56 ± 0.5 |
| 30 Hrs |
2.63 ± 0.77 |
2.04 ± 0.80 |
1.64 ± 0.64 |
| 32 Hrs* |
5.29 ± 2.75 |
2.42 ± 0.88 |
1.48 ± 0.59 |
| 34 Hrs |
2.13 ± 0.81 |
2.20 ± 0.82 |
1.96 ± 0.68 |
| 36 Hrs |
2.24 ± 1.03 |
3.17 ± 1.57 |
1.76 ± 0.61 |
| 38 Hrs |
3.84 ± 1.88 |
2.86 ± 1.08 |
1.88 ± 0.73 |
| 40 Hrs* |
5.48 ± 2.59 |
2.72 ± 1.24 |
2.08 ± 0.76 |
| 42 Hrs |
1.84 ± 0.75 |
2.13 ± 0.85 |
2.56 ± 0.51 |
| 44 Hrs |
2.46 ± 0.53 |
2.68 ± 1.85 |
2.00 ± 0.82 |
| 46 Hrs |
3.88 ± 1.98 |
4.33 ± 2.62 |
2.88 ± 0.67 |
| 48 Hrs* |
4.46 ± 2.71 |
4.48 ± 4.02 |
3.12 ± 1.17 |
50 Hrs
|
4.48 ±
2.59 |
4.96 ±
3.42 |
3.68 ±
2.46 |
|
| |
| Demographic data as shown was comparable. VAS was significantly
less in the infusion groups at 6, 8, 14, 16, 24, 32, 40
and 48 hours. After the bolus dose of tramadol there was
fall in VAS whereas in the infusion groups steady VAS was
observed in range of 0-3. The average duration of pain relief
following a tramadol bolus was 5.46 ± 1.25 hours.
VAS in bupivacaine infusion group was less than in tramadol
infusion group but not statistically significant. |
| |
| Table 3 : Rescue analgesia
requirement |
| No (%) Patients |
Group A 24 (80) |
Group B 6 (20) |
Group C 4 (13) |
| Table 4 : Adverse
effects |
Adverse effects
No (%)
|
Group A |
Group B |
Group C |
| Vomiting |
2 (6) |
6 (20) |
0 |
| Nausea |
6 (20) |
14 (46) |
0 |
| Abdominal distension |
1 (3) |
2 (6) |
0 |
| Paraesthesia |
0 |
0 |
2 (6) |
| Transient muscle weakness |
0 |
0 |
1 (3) |
| Respiratory depression |
0 |
0 |
0 |
| Hypotension |
0 |
0 |
0 |
|
| |
80% of bolus group patients needed rescue analgesia
as compared to 20% and 13% patients in the tramadol and
bupivacaine infusion groups respectively.
No significant changes in respiratory or haemodynamic
parameters were seen. Incidence of nausea and vomiting
was seen only in tramadol group. In bolus group 6 patients
experienced nausea and 2 had vomiting while in infusion
group 14 had nausea and 6 had vomiting which subsided
with IV on-dansetron. Abdominal distension was also noted
only in tramadol group, which was relieved by passing
RT/flatus tube. Two patients in bupivacaine infusion group
had transient paraesthesia and motor weakness, which recovered
on stoppage of infusion. |
| |
| Discussion |
NSAIDs and weak opioids are adequate for
mild to moderate pain; these drugs may be ineffective
in patients with moderate to severe pain. Local anaesthetics
as well as opioids have been demonstrated to be highly
effective analgesics. The main limitation to its widespread
use is the need for repeated administration. Continuous
infusion overcomes this difficulty and avoids fluctuations
in the level of analgesia.
We found that 2-2.5 mg/ml @ 5 ml/hr of tramadol infusion
provides better pain relief than 2 mg/kg bolus which is
similar to results obtained by Rud and Fischer et
al.8 Siddik et al5 found that duration of analgesia
after 100 mg of tramadol given epidurally to be 4.5 ±
3.1 hours, where as Dellikan et al have reported it to
be 9.36 hours. We found analgesic effect to last for 5.46
± 1.25 hours subject to patient variability. We
report lower VAS with bupivacaine infusion as compared
to tramadol infusion or bolus. Lin WQ et al2
obtained similar results. Side effects like nausea, vomiting
was much more in the tramadol infusion group that subsided
with IV ondansetron. Two patients in the same group had
abdominal distension and in 1 patient in the bolus group,
for which Ryle’s tube and flatus tube was passed.
Two patients in bupivacaine group complained of transient
paraesthesia and one of motor weakness, which was relieved
after infusion was stopped.
Twenty four patients in bolus group required rescue analgesic
as against only 6 in tramadol infusion group and 4 in
bupivacaine group. Hence continuous infusion avoided fluctuations,
maintaining a steady level of analgesia. Bupivacaine infusion
provided better pain relief with lesser side effects.
Thus local anaesthetic infusions using elastomeric balloon
pumps can be used to provide steady and safe pain relief
in patients with moderate to severe pain in the post-operative
period. |
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| References |
| 1. |
Gurses E, Sungurtekin H, et al.
The addition of droperidol or clonidine to epidural
tramadol shortens onset time and increases duration
of postoperative analgesia. Can J Anaesth
2003; 50 (2) : 147-52. |
| 2. |
Lin WQ, Zeng WA, et al. Comparison
of postoperative analgesia with tramadol, morphine
versus their combination in patients undergoing abdominal
cancer surgery. Ai Zheng 2002; 21 (7) : 794-6. |
| 3. |
Bloch MB, Dyer RA, Tramadol infusion
for postthoracotomy pain relief a placebo controlled
comparison with epidural morphine. Anesth Analg
2002; 94 (3) : 523-8. |
| 4. |
Yaddanapudi LN, Wig J, et al.
Comparison of efficacy and side effects of epidural
tramadol and morphine in patients undergoing laminectomy:
a repeated dose study. Neurol India 2000;
48 (4) : 398-400. |
| 5. |
Siddik-Sayyid S, Aouad-Maroun M, et
al. Epidural tramadol for postoperative pain
after Caesarean section. Can J Anaesth 1999;
46 (8) : 731-5. |
| 6. |
Lewis KS, Han NH, et al. Tramadol:
A new centrally acting analgesic. Am J Health
Syst Pharm 1997; 54 (6) : 643-52. |
| 7. |
Grace D, Fee JP, et al. Ineffective
analgesia after extradural tramadol hydrochloride
in patients undergoing total knee replacement. Anaesthesia
1995; 50 (6) : 555-8. |
| 8. |
Rud U, Fischer MV, et al.
Postoperative analgesia with tramadol. Continuous
infusion versus repetitive bolus administration. Anaesthesia
1995; 43 (5) : 316-21. |
| 9. |
Delilkan AE, Vijayan R. Epidural tramadol
for postoperative pain relief. Anaesthesia
1993; 48 (4) : 328-31. |
| 10. |
Baraka A, Jabbour S, et al.
A comparison of epidural tramadol and epidural morphine
for postoperative analgesia. Can J Anaesth
1993; 40 (4) : 308-13. |
|
| MORTALITY
AMONG DOCTORS IN UGANDA IS HIGH
A high proportion of doctors who graduated in
1984 in Uganda died within 20 years of graduation.
Dambisya obtained information about 74 of the 77
doctors who graduated in Makerere, Uganda, and found
that 22 had died. The most common causes of death
were AIDS (11 cases) and suicide (six cases, five
related to knowledge or fear of being HIV positive).
Two thirds of the surviving graduates work in Uganda,
mainly in the public sector.
BMJ, 2004; 329 : 600.
MAPPING THE CAUSE OF CROHN'S DISEASE
Mycobacterium avium subspecies paratuberculosis
(MAP) is suspected of having a role in Crohn's disease,
but evidence for a link is controversial. Saleh
Naser and colleagues tested the blood of individuals
with Crohn's disease or ulcerative colitis, or with
no inflammatory bowel disease. They detected viable
MAP in peripheral blood in a higher proportion of
individuals with Crohn's disease than in controls.
In a Comment paper, Warwick S Selby says that this
study raises many important questions, and states
that the role of MAP in Crohn's disease cannot be
ignored.
BMJ, 2004: 1013, 1039. |
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