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 »  Abstract
 »  Introduction
 »  Material and methods
 »  Results
 »  Discussion
 »  References

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Year : 2000  |  Volume : 48  |  Issue : 4  |  Page : 398-400

Comparison of efficacy and side effects of epidural tramadol and morphine in patients undergoing laminectomy : a repeated dose study.


Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.

Correspondence Address:
Department of Anaesthesia, Postgraduate Institute of Medical Education and Research, Chandigarh, 160012, India.

  »  Abstract

Tramadol acts through multiple mechanisms and has a low risk of post operative respiratory depression. We compared the efficacy of epidural tramadol with that of morphine for postoperative analgesia in these patients. The demographic data and the summed pain intensity difference scores (SPID) were similar in both the groups. The time to first supplementary dose was significantly shorter in the tramadol group compared to the morphine group (p<0.05). No patient in either group suffered respiratory depression.

How to cite this article:
Yaddanapudi L N, Wig J, Singh B, Tewari M K. Comparison of efficacy and side effects of epidural tramadol and morphine in patients undergoing laminectomy : a repeated dose study. Neurol India 2000;48:398-400


How to cite this URL:
Yaddanapudi L N, Wig J, Singh B, Tewari M K. Comparison of efficacy and side effects of epidural tramadol and morphine in patients undergoing laminectomy : a repeated dose study. Neurol India [serial online] 2000 [cited 2020 Mar 30];48:398-400. Available from: http://www.neurologyindia.com/text.asp?2000/48/4/398/1488




   »   Introduction Top

Tramadol is a synthetic opioid with a structure of (±)-trans-2 [(di-methylamino)methyl] 1-(m-methox-yphenyl) cyclohexanol hydrochloride. Its analgesic activity is mediated through an agonist action at all types of opioid receptors with some µ receptor selectivity. In addition it inhibits noradrenaline uptake and stimulates serotonin release. Increased concentrations of these neurotransmitters in the descending pathways enhance the analgesic response. Up to 60% of the analgesic activity of tramadol is thought to be mediated through its nonopioid actions.[1] Tramadol has minimal respiratory depressant effect, probably because of its multiple routes of action. Its haemodynamic effects are negligible. Tramadol has been used for postoperative pain relief in a large variety of surgical procedures by various routes. Baraka et al used it epidurally in major abdominal surgeries with good effect.[2] Delilkan used it in gynaecological surgery.[3] Laminectomy for prolapsed intervertebral disc results in severe postoperative pain requiring large amounts of parenteral opioid analgesics for control. This study was designed to compare the efficacy of epidural tramadol with that of epidural morphine for postoperative analgesia in patients undergoing laminectomy.


   »   Material and methods Top

After obtaining written informed consent, 30 ASA class I or II patients undergoing thoracic or lumbar laminectomy for prolapsed intervertebral disk were studied. Patients with respiratory dysfunction, motor deficit above T10 level, opioid addiction and those scheduled to undergo laminectomy of three or more vertebrae was excluded. The patients were randomly assigned to one of two groups preoperatively. All patients were premedicated with 5 mg of oral diazepam, and 0.1 mg/kg of morphine and 1 mg/kg of promethazine intramuscularly on the morning of surgery. A balanced anaesthetic technique using thiopentone, succinylcholine, pancuronium, nitrous oxide, oxygen and halothane was used in all patients. Morphine was used for intraoperative analgesia.
At the end of the laminectomy, the surgeon introduced an 18 G epidural catheter into the epidural space at the level of the surgery under vision. At the end of surgery, the patients in group I received 3 mg of morphine in 10 ml of saline and those in group II received 50 mg of tramadol in 10 ml saline. The patients were observed in the post-anaesthesia recovery room for 24 hours postoperatively. The observer anaesthetist was blinded to the drug administered. The patients' heart rate, blood pressure and respiratory rate were monitored continuously. Postoperative pain was measured 2 hourly using a 10 cm visual analogue scale (VAS). Time to the second dose of the study drug, and incidence of side effects were noted. We planned to do arterial blood gas analysis in case of any respiratory depression. Respiratory depression was defined as a respiratory rate of less than 10 breaths per minute with PaCO2 > 45 mm Hg and PaO2 < 60 mm Hg or SpO2 < 90%. If the patient spontaneously complained of pain and the VAS score was over 5 cm, a second dose of the drug was given epidurally. Two doses were permitted in the first 12 hours and two more in the second 12 hours. If the patient had insufficient analgesia even after receiving two doses, rescue analgesia was planned in the form of 3 mg of intravenous morphine.
Statistical analysis : The VAS scores were converted to 'pain intensity difference (PID)' scores by subtracting them from the score taken at baseline. These were then weighted for the time between the observations and then summed over the observation period to get 'summed PID (SPID)' scores.
Demographic data were compared using student's unpaired test and X2 test. The monitored and calculated parameters were analysed using Student's t test, X2 test and Mann Whitney U test.


   »   Results Top

The age and weight of the patients in the two groups were comparable. The sex ratio of the two groups was also similar (X2 analysis). The intraoperative use of morphine was similar in the two groups [Table I]. The SPID scores over the period of observation were similar in the two groups as were the number of supplementary analgesic doses required [Table II]. However, the time to first supplementary dose was significantly shorter in the tramadol group as compared to the morphine group (p < 0.050). No patient in either group suffered respiratory depression. No one required rescue intravenous analgesic. The incidence of pruritis, and nausea and vomiting was almost similar in the two groups. Since all patients were catheterized, urinary retention could not be detected.


   »   Discussion Top

We studied the analgesic effectiveness of tramadol by administering the drug multiple times to the same patients. There are a number of reasons for using this approach. In clinical practice, analgesic drugs are almost always administered or taken in series rather than as isolated single doses. Moreover, a true comparison of the effects of two or more drugs cannot be made unless steady-state conditions prevail, and these conditions can only be approached or achieved by repeated or continuous drug administration. Lastly, cumulative effects, whether desirable or undesirable, only manifest after chronic or repeated administration. The use of repeated-dose studies has been advocated for the assessment of analgesic effecacy.[4]
Visual analogue scale (VAS) scores are probably the most accurate way of measuring the subjective pain sensation. Traditional VAS measures pain and not pain relief. However, it can be converted to a pain relief scale by calculating the pain intensity differences (PID) from the baseline VAS score at different points of measurement. Measurement of VAS is periodic, resulting in point estimations of pain severity. The overall pain experience is not measured. By weighing the PID for the duration between VAS measurements and then summing up the PID scores, we convert the large number of VAS readings to a summated PID (SPID) score for each patient. This is an estimate of the area under the time-effect curve (AUC),[5] a summary measure of the pain relief over the period of study. However, this technique does have the drawback of confounding onset and duration of analgesia with amplitude. A moderately effective drug acting for a long period cannot be distinguished from a very effective short acting one. The time for the requirement of the second analgesic dose, however, can distinguish these very effectively. We have used both the measurements in our study.
The SPID scores were comparable in the two groups showing that the overall pain relief was similar with both drugs. However, the patients in the tramadol group required the first supplemental analgesic at a mean of 310 minutes while the patients who received morphine were pain free for more than double this time (mean 670 minutes). This indicates that tramadol acts for a shorter period than morphine, but is at least as effective in relieving pain as morphine. The duration of analgesia after the first dose of tramadol was much shorter in our patients compared to the Figures in the studies by Baraka et al[2] and Delilkan et al[3]. This is explained by the fact that while the former used 100 mg and the latter used 75 mg of tramadol, we used 50mg. The incidence of side effects such as pruritis, and nausea and vomiting was similar in the two groups. There was no incidence of respiratory depression with either drug. Nausea and vomiting were probably absent because the patients were not ambulatory.
Some shortcomings of the present study are the absence of pulse oximetry monitoring in all patients, and the small number of patients. However, no patient had clinically evident hypoxia or any sequelae attributable to it. Within its limitations, the present study shows that epidural tramadol can provide adequate postoperative analgesia comparable to that of epidural morphine in patients undergoing laminectomy.


 

  »   References Top

1.Lee CR, McTavish D, Sorkin EM : Tramadol - A preliminary review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in acute and chronic pain states. Drugs 1993; 46 : 313-340.   Back to cited text no. 1    
2.Baraka A, Jabbour S, Ghabash M et al : Comparison of epidural tramadol and epidural morphine for postoperative analgesia. Can J Anaesth 1993; 40 : 308-313.   Back to cited text no. 2    
3.Delilkan AE, Vijayan R : Epidural tramadol for postoperative pain relief. Anaesthesia 1993; 328-331.   Back to cited text no. 3    
4.Houde RW : Repeated-dose clinical analgesic assays. In: Advances in pain research and therapy. Volume 18: The design of analgesic clinical trials. Max MB, Ponteroy RK and Laska EM eds. Raven Press, New York. 1991; 166.   Back to cited text no. 4    
5.Sriwatanakul K, Lasagna L, Cox C : Evaluation of current clinical trial methodology in analgesitnetry based on expert's opinion and analysis of several analgesic studies. Clin Pharmacol Ther 1983; 34 : 277-283.   Back to cited text no. 5    

 

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