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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****
 

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.

 
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.

 
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.
 
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.

 
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.

 

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