|Year : 2014 | Volume
| Issue : 1 | Page : 29-35
A comparative double blind study of tramadol and fentanyl as adjuvants to lignocaine for intravenous regional anesthesia for forearm orthopedic surgeries
Khushboo Dubey1, Snigdha Paddalwar2, Aruna Chandak3
1 Department of Anesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India
2 Department of Cardiac Anesthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India
3 Department of Anaesthesia, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Wardha, Maharashtra, India
|Date of Web Publication||15-Mar-2014|
Department of Aneasthesiology, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences, Wardha - 442 001, Maharashtra
Source of Support: None, Conflict of Interest: None
Introduction: IVRA is safe, technically simple, and cost effective technique compared to general anaesthesia with success rates of 94 to 98% for upper and lower limb surgeries. It also provides bloodless field during surgery. To overcome these disadvantages various adjuvants have been tried. We compared Fentanyl and tramadol as adjuvants to lignocaine for IVRA for upper limb surgeries. Material and Method: After approval from institutional ethical committee, 60 patients of either sex belonging to ASA grade I and II, in the age range of 20 to 60 years scheduled to undergo upper limb orthopaedic surgery either elective or emergency were included in the study. All the patients were administered intravenous regional anaesthesia (IVRA) after obtaining written informed consent. Patients enrolled in the study were divided into 2 groups of 30 each by a computer generated Randomization program. Group LF-received 40 ml of 0.5% Lignocaine with Fentanyl 1 ug/kg. Group LT-received 40 ml of 0.5% Lignocaine with Tramadol 1 mg/kg. Double tourniquet technique was used. The arm was exsanguinated with Eschmark bandage and proximal cuff was inflated followed by injection of the study drug. Parameters observed were time of onset of sensory and motor block, intraoperative conditions post operative analgesia and adverse effects. Data was expressed as mean ± SD (Standard Deviation) of statistical analysis. Statistical Analysis was done by using Discriptive and Inferencial statistics using chi-square test and students unpaired t-test. The software used in analysis were SPSS 17.0 version and Graph Pad Space Prism 5.0 and results were tested at 5% level of significance. Results: Patients were comparable demographically. Mean values of onset of sensory blockade was 6.76 ± 1.30 min in Group LT and 7.13 ± 0.81 min in Group LF.
Keywords: Fentanyl, intravenous regional anesthesia, tramadol
|How to cite this article:|
Dubey K, Paddalwar S, Chandak A. A comparative double blind study of tramadol and fentanyl as adjuvants to lignocaine for intravenous regional anesthesia for forearm orthopedic surgeries. Indian J Pain 2014;28:29-35
|How to cite this URL:|
Dubey K, Paddalwar S, Chandak A. A comparative double blind study of tramadol and fentanyl as adjuvants to lignocaine for intravenous regional anesthesia for forearm orthopedic surgeries. Indian J Pain [serial online] 2014 [cited 2020 Apr 2];28:29-35. Available from: http://www.indianjpain.org/text.asp?2014/28/1/29/128889
| Introduction|| |
Regional anesthesia holds an important place in clinical practice because of its simplicity, safety and economy. Intravenous regional anesthesia (IVRA) has evolved as a safe, reliable, and cost-effective technique for providing anesthesia as well as bloodless field during upper limb surgery especially in patients who are not adequately prepared for general anesthesia. , It has been postulated that the site of action in IVRA is probably by blockade of small nerves or possibly nerve endings and not the major nerve trunks. , The disadvantages include local anesthetic (LA) toxicity, poor muscle relaxation, tourniquet pain, and minimal postoperative analgesia.  The ideal IVRA solution should have rapid onset, reduced dose, reduced tourniquet pain, and extended period of postoperative analgesia.  These drawbacks, were tried to overcome by adding various adjuvants like tramadol, clonidine, dexmedetomedine, ketorolac, magnesium, etc.
As the first family of analgesics opioids are the natural choice. Tramadol is a synthetic opioid with unique dual mechanism of action. It exerts agonist action at opioid receptors and interferes with neurotransmitter reuptake. Another potent opioid is fentanyl which can be added to the LAs to increase the success rate of the blocks and prolong postoperative analgesia. This study was carried out with the aim of comparing both the drugs tramadol and fentanyl for IVRA. Aim of the study was to compare duration of onset of sensory and motor block, quality of block, duration of postoperative analgesia, and adverse effects if any. After approval from institutional ethical committee, 60 patients of either sex belonging to American Society of Anesthesiologists (ASA) grade I and II, in age range of 20-60 years scheduled to undergo upper limb orthopedic surgery either elective or emergency were included in the study and were administered IVRA after obtaining written informed consent.
All the patients were divided into two groups of 30 each by a computer-generated randomization program.
- Group lignocaine-fentanyl (LF) - 40 ml of 0.5% lignocaine with fentanyl 1 μg/kg.
- Group lignocaine-tramadol (LT) - 40 ml of 0.5% lignocaine with tramadol 1 mg/kg.(28
After preanesthetic examination, patients were explained about the procedure. Preoperative vital parameters were recorded and an intravenous (IV) line was secured in nonoperating limb. A 22G IV cannula was secured in the dorsum of the hand which was to be operated. After the complete exsanguination of the arm two tourniquets were applied as proximal and distal. Proximal tourniquet was inflated 100 mmHg above systolic blood pressure. Study drug was prepared and injected by a resident not participating in the study. After 10 min, the distal cuff was inflated and the proximal (upper) cuff was deflated. Inj. midazolam 0.05 mg/kg IV was given as premedication. After completion of the surgery, the tourniquet was deflated by intermittent deflation and reinflation method over a period of 2-3 min. In no circumstances, tourniquet was released before 20 min after injection of drug. Pain was assessed by using visual analog scale (VAS) of 0-10. A score of 0 was given for no pain and 10 for intolerable pain. Inj. fentanyl (1 μ/kg) IV was given if VAS was >5. After 40 min tourniquet was deflated completely as a simple maneuver. Any signs and symptoms of LA toxicity like perioral numbness, giddiness, tinnitus, nausea, vomiting, pain, skin rashes, hypotension, bradycardia, convulsions, and electrocardiogram (ECG) were monitored strictly.
Onset of sensory block
The time interval after completion of injection of solution to the loss of pin prick sensation using 23G hypodermic needle, checked at six separate areas of the hand selected to represent the innervation of the ulnar, median, and radial nerves. 
Onset of motor block
The inability of the patient to move the fingers and flex the elbow in supine position. 
Intraoperative conditions 
Intraoperative degree of muscle relaxation was assessed using the following grading  [Table 1].
- Intraoperative assessment of quality of analgesia was assessed by VAS score.
- Based on the above mentioned parameters, intraoperative conditions  were graded as:
- Excellent - Indicated complete loss of touch, position sense, and pain sensation with no sensitivity to pin prick or deep pressure with marked or total paralysis of muscle.
- Good - Loss of pain, touch, and position sense; but retained a sensory response to maximum pressure applied to the fingernail with minor movements of digits possible.
- Moderate - Anesthesia which was complete in most areas but incomplete in small region (patchy). Mild pain or discomfort during the reduction or during the operative procedure.
- Poor/failure - Failure to obtain anesthesia, moderate to marked pain when carrying out the manipulative or surgical procedure or both.
Total duration of surgery 
The duration between first skin incision and complete closure was the total duration of surgery.
Total duration of analgesia 
This was the time between the administration of drugs and first demand of systemic (rescue) analgesics.
Postoperative pain assessment was done every hour up to the administration of first systemic rescue analgesic. All the data were noted by the authors as per the study protocol.
Postoperatively, sensory block, side effects if any and vitals of the patients were noted every hour. Rescue analgesic was administered in the form of inj. diclofenac sodium intramuscularly in the dose of 1.5 mg/kg. Postoperative nausea and vomiting was treated with inj. ranitidine 50 mg IV and inj. ondansetron 4 mg IV. Data was expressed as mean ± standard deviation (SD) of statistical analysis. Statistical analysis was done by using descriptive and inferential statistics using chi-square test and Student's unpaired t-test. The software used in analysis were Statistical Package for Social Sciences (SPSS) 17.0 version and Graph Pad Space Prism 5.0 and results were tested at 5% level of significance.
| Results|| |
The two groups were comparable in respect of their physical parameters [Figure 1], [Table 2] and [Table 3].
|Figure 1: Comparison of patients according to age (years). Total no. of patients = 60, n = 30|
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Mean values of onset of sensory blockade was 6.76 ± 1.30 min in Group LT and 7.13 ± 0.81 min in Group LF which suggests earlier onset of sensory block in tramadol group as compared to fentanyl, but the difference is (P > 0.05) statistically insignificant [Table 4]. Siddiqui et al.,  compared tramadol as an adjunct to lignocaine for IVRA with the control group and found that tramadol shortens the sensory block onset time which was statistically significant. Similarly Chakole et al.,  compared tramadol as an adjunct to lignocaine for IVRA with the control group and found significantly shorter sensory block onset time in tramadol group. Tramadol modifies the action of lignocaine, providing shorter onset times. , These results are consistent with the findings of our study, though statistically insignificant, as we compared tramadol with fentanyl rather than with a control group. Alaryut et al.,  compared sufentanil, tramadol, and clonidine when added to lignocaine for IVRA and found shorter onset times in all the three groups as compared to control.
|Table 4: Comparison of patients according to the onset of sensory block (min)|
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In contrast to above mentioned studies few studies have demonstrated no advantage in respect of onset time when opioids were used as adjuvants.
Bansal et al., compared butorphanol as an adjuvant to lignocaine with the control group for IVRA, but found no significant benefit in respect of onset time.
Geze and Hulya  compared fentanyl with tramadol for axillary plexus block and found onset time for sensory block shorter in tramadol group, this finding is similar to our study.
Ko et al.,  in their study compared acetaminophen and ketorolac as adjuncts to lignocaine for IVRA and found shorter onset time in acetaminophen group as compared to ketorolac and control group.
Fentanyl in various studies has shown varied result although it increased the success rate of the block but no effect was seen on the time to onset of nerve block. ,,
The mean values for onset of motor block was 11.66 ± 1.24 min for group LT and 11.90 ± 1.18 min for Group LF which suggests earlier onset of motor block in tramadol group. The difference in mean values is statistically insignificant (P > 0.05) [Table 5].
Santosh et al.,  reported statistically significant delay in onset of motor block when used fentanyl as an adjuvant to lignocaine as compared with control group.
Kaabachi et al.,  investigated the addition of varying doses of tramadol to lignocaine 1.5% solution and reported that the benefit of block prolongation associated with the addition of 200 mg tramadol was limited by the slow onset of the block.
Sen et al.,  evaluated the effect of lornoxicam when added to lignocaine for Bier's Block and found motor block onset time significantly shorter as compared to control group. Kumar et al.,  added pancuronium 0.5 mg to lignocaine for IVRA and compared with control, they found that the patients in pancuronium group had significantly early onset of motor block.
Regarding intraoperative conditions we found excellent operating conditions in 24 patients, four patients had good whereas two patients had fair operating conditions in group LT. In group LF, 21 patients had excellent, seven patients had good, and two patients had fair operating conditions. The difference in both the groups was statistically insignificant as P-value was > 0.05 [Table 6].
|Table 6: Distribution of patients according to intraoperative condition in both the groups|
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We found excellent operating conditions in both the groups. Siddiqui et al.,  when added tramadol as an adjuvant to local anesthetic found improved perioperative analgesia and better tourniquet tolerance rendering operative conditions satisfactory similar to our study.
Alaryut et al.,  while using tramadol, sufentanil, and clonidine for IVRA found reduced intraoperative use of IV analgesic supplements similar to our study; whereas in contrast to our study, Aslan et al.,  did not find any advantage in respect of tourniquet pain and motor block quality while using tramadol along with lignocaine for IVRA.
Gobeaux et al.,  added 100 μg of fentanyl to adrenalized lignocaine for brachial plexus block and reported enhanced intensity of the sensory and motor block. Geze et al.,  found tramadol better than fentanyl in axillary plexus block in terms of block quality.
Sarihasan et al.,  added 100 mg tramadol as an adjunct to supraclavicular blocks and found improved quality of anesthesia.
Mean duration of analgesia in group LT was 581.33 min and in group LF was 183.33 min. We found significantly prolonged analgesia in group LT which was statistically significant as P < 0.05 [Table 7].
|Table 7: Comparison of mean duration of analgesia (min) in both the groups|
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Aslan et al.,  in a study comparing tramadol and morphine as adjuvants to lignocaine for IVRA found that addition of these drugs provided significantly prolonged postoperative analgesia, these findings are similar to our study.
In contrast to our findings, Gregoire et al.,  in a study found no benefit of adding tramadol to lignocaine for IVRA in terms of postoperative analgesia, though the evaluation of postoperative analgesia was not their main evaluation criteria and number of patients were too small.
Chakole et al.,  reported significantly prolonged duration of analgesia (363 min) after deflation of tourniquet in the group which was given combination of tramadol and lignocaine as compared to the lignocaine group, for IVRA. Their findings are similar to our study where we found significant prolongation of postoperative analgesia in tramadol group as compared to fentanyl group. We did not find any of the studies comparing tramadol and fentanyl for IVRA, though few studies have compared these drugs for brachial plexus block.
Altunkaya et al.,  have studied local anesthetic effects of tramadol and found its action as local anesthetic comparable to prilocaine.
Pitakanen et al.,  in a study evaluated the effect of adding fentanyl to prilocaine for IVRA and found no significant benefit on duration of postoperative analgesia, similar to our study.
Siddiqui et al.,  compared tramadol with control when used with lignocaine for IVRA and found significantly prolonged postoperative analgesia in tramadol group. Goel et al.  also demonstrated that tramadol assured significantly longer pain free interval of 16.8 ± 9.07 h (P < 0.05), while ketorolac had 12.9 ± 8.48 h.
Prolonged postoperative analgesia with tramadol could be due to preemptive analgesia, other explanation being the prolonged action of the active metabolite of tramadol, O-desmethyl tramadol, which has longer half-life (7.6 ± 1.1 h) than the parent drug, with half-life of 5.2 ± 0.9 h and has analgesic action similar to the parent drug. 
Langlois et al.,  found that postoperative analgesia was increased slightly but not significantly with LT group (130 ± 20 min) as compared to lignocaine group (110 ± 70 min); P = 0.08.
This was in contrast to our study which had prolonged postoperative analgesia in LT group. The explanation given by the author for the failure was that the postoperative VAS was not the main evaluation criteria, the number of patients were probably too small to perform this evaluation.
In a study by Sztark et al.,  assessed the efficacy of adding fentanyl and pancuronium in reducing the concentration of lignocaine used for IVRA. Their main objective was to measure efficacy of adjuvants and successful regional anesthesia with lower concentration of lignocaine. They also found that time to first postoperative request for analgesic was not significantly different between the two groups. Lignocaine group had 36 ± 17 min and lignocaine with adjuvants had 45 ± 21 min.
Two patients in LT group had nausea and vomiting postoperatively. One patient in this same group had tourniquet pain after 20 min and was managed by inflation of distal cuff followed by deflation of proximal cuff, thereafter patients were comfortable. In group LF three patients complained of tourniquet pain in 10 min and were managed with cuff deflation, as the P value < 0.05 [Table 8], the difference in both the groups is statistically significant. None of the patients in both the groups had pruritus, giddiness, and rashes.
|Table 8: Comparison of patients according to adverse effects in both the groups of patients|
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Goel et al., , in their study noted incidence of tourniquet pain intraoperatively in 26.6% of total patients.
In our study, three of patients in LF group and 1 patient in LT group complained of tourniquet pain with VAS of 4 respectively, which did not require any rescue analgesia, and were managed with touniquet deflation.
Acalovschi et al.,  in their study noted increased incidence of skin rash below the tourniquet level in LT group (nine patients) when compared with lignocaine group (no patient) (P < 0.01).
| Conclusion|| |
Tramadol and fentanyl when used as adjuvants to lignocaine for IVRA significantly improves the intraoperative conditions by providing superior quality of block.
Tramadol significantly prolongs the postoperative analgesia as compared to fentanyl. Both the drugs are comparable in terms of onset of block.
To conclude we found tramadol as an excellent adjuvant when added to lignocaine for IVRA in respect of block quality, postoperative analgesia, and has minimum adverse effects. Hence, we recommend tramadol as an effective adjunct to IVRA.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8]