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titolo breve: TRAMADOL AND 0.5% LEVOBUPIVACAINE FOR SINGLE-SHOT COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
O R I G I N A L A R T I C L E
Tramadol and 0.5% levobupivacaine for single-shot interscalene block: effects on postoperative analgesia in patients undergoing shoulder arthroplasty F. ALEMANNO 1, D. GHISI 2, A. FANELLI 2, A. FALIVA 3, B. PERGOLOTTI 3, F. BIZZARRI 3, G. FANELLI 3 1Department of Anesthesia and Pain Therapy, Ospedale San Camillo, Brescia, Italy; 2Department of Anesthesia and Pain Therapy; Istituti Ospitalieri di Cremonaz Cremona, Italy; 3Department of Anesthesia, Intensive Care and Pain Therapy; Background. The aim of this study was to evaluate the efficacy of tramadol as an adjuvant to the local anaesthetic
solution in patients undergoing shoulder arthroscopy for rotator cuff tear after middle interscalene block (MIB).
Methods. We enrolled 120 patients (ASA I-II), scheduled for arthroscopic surgery for rotator cuff tear. The patients
were sedated with midazolam 0.02 mg/kg and haloperidol 2 mg i.v. before performing MIB. All subjects underwent a MIB with 0.4 mL/kg of 0.5% levobupivacaine. After computerized randomization, all patients were allocated in 1 of 3 groups, each including 40 subjects. Group Placebo (Group P) received 0.4 mL/kg of 0.5% levobupivacaine plus isotonic sodium chloride for MIB and isotonic sodium chloride i.m. Group “Perineural Tramadol” (Group TPN) received 0.4 ml/Kg of 0.5% levobupivacaine plus 1.5 mg/kg of tramadol perineurally and isotonic sodium chloride i.m. Group “Intramuscular Tramadol” (Group TIM) received 0.4 ml/Kg of 0.5% levobupivacaine plus isotonic so- dium chloride perineurally and 1.5 mg/kg of tramadol i.m.
Results.
The MIB onset times were not statistically different in the three groups. The duration of analgesia was significantly longer in Groups TPN and TIM, where tramadol was administered, either i.m. or perineurally, compared with the placebo group. A significant statistical difference was found in the duration of analgesia between the group Conclusion. The addition of tramadol to the local anaesthetic solution administered for MIB provided a longer
duration of analgesia compared with placebo and i.m tramadol administration in patients undergoing arthroscopic surgery for rotator cuff tear. (Minerva Anestesiol 2012;78:291-96) Key words: Tramadol - Postoperative period - Analgesia.
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Shoulder arthroplasty is related to severe pain longed analgesia, use of additives has been often in the postoperative period.1 Interscalene bra- proposed for peripheral nerve blocks to improve chial plexus block provides adequate postopera- quality and duration of anesthesia and postop- tive analgesia, reducing time-to-home discharge erative pain relief.7 in patients undergoing one-day surgery.2, 3 The The direct action of opioid analgesics such as efficacy of a middle approach to the interscalene morphine, fentanyl and sufentanil on the pe- block for the brachial plexus has been already de- ripheral nervous system are still debated, but buprenorphine and tramadol seem to pass the Although peripheral nerve blocks with long- neuronal membrane and diffuse within the in- acting local anesthetics (LA) can provide pro- terstitial or axonal fluid as lipophylic drugs.8, 9 COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
TRAMADOL AND 0.5% LEVOBUPIVACAINE FOR SINGLE-SHOT INTERSCALENE BLOCK Tramadol has been also proven to have a cen- (0.03 mL/kg) and the i.m. isotonic sodium chlo- tral analgesic effect due to its monoaminergic ride (0.03 mL/kg); and m-receptor agonistic activity, together with some peripheral local anesthetic properties with ceived the anesthetic mixture containing 0.4 ml/ low incidence of serious adverse events.10, 12 Ani- Kg of 0.5% levobupivacaine plus tramadol (1.5 mal investigations have shown effects of trama- mg/kg) and the i.m. isotonic sodium chloride dol on the uptake and release of norepinephrine (0.03 mL/kg); 3) group intramuscular tramadol (Group TIM) The aim of this prospective, randomized, dou- received the anesthetic mixture containing 0.4 ble-blinded study was to evaluate the efficacy of ml/Kg of 0.5% levobupivacaine plus isotonic perineural tramadol, added to the local anesthet- sodium chloride (0.03 mL/kg) and the i.m. tra- ic solution, in prolonging postoperative analge- sia in patients undergoing shoulder arthroscopy Immediately after the block, all patients also for rotator cuff tear after middle interscalene received an i.m injection of the study solution according to the study randomization (either 1.5mg/Kg of 5% tramadol or 0.03ml/Kg of iso- Materials and methods
35-mm long Teflon-coated needle (Locoplex; mittee and after written informed consent was Vygon, S.A., Ecouen, France) connected to the signed, 120 patients (ASA I-II), older than 18 negative lead of the nerve stimulator (Plexival; years, scheduled for arthroscopic surgery for ro- Medival, Padova, Italy). The stimulating cur- rent was initial y set at 0.5 mA, the stimulus Patients with previous history or clinical frequency at 2 Hz, and impulse duration at 100 evidence of central or peripheral neurological mil iseconds. After local anesthetic infiltration, disease, coagulopathy or anticoagulant/antiag- the needle was inserted 2 mm lateral to the sub- gregant therapy not properly suspended preop- clavian artery pulse, fol owing a straight line, eratively, controlateral recurrent and/or phrenic which from the midpoint of the clavicle was the nerve paresis and those unable to cooperate were lateral tangent of the subclavian artery pulse, excluded. Patients receiving clonidine, opioids, but lying deeper on the transverse plane of C7 or beta-blockers, and patients with a known spinous process. If no twitch was elicited, small allergy to any of the study drugs were also ex- adjustments were made in an anterior or poste- rior direction until a twitch of the deltoid, bi- Standardized monitoring was applied (EKG ceps, or triceps muscle was obtained. The stimu- lead II, blood pressure cuff and pulse oximetry) lating current was progressively decreased to 0.2 and i.v. access secured in all patients. All patients mA. The entire volume was slowly injected un- were sedated with midazolam 0.02 mg/kg and der intermittent aspiration with a single injec- haloperidol 2 mg i.v. before performing MIB. All tion technique after ensuring that the twitches No additional reproduction is author.
subjects underwent a middle interscalene block ceased immediately with injection of 1ml of the (MIB) as previously described with 0.4 mL/kg anesthetic solution.
of 0.5% levobupivacaine plus the study solution Sensory blockade of the circumflex, muscolo- according to the study randomization (either 1.5 cutaneous and radial cutaneous nerves of the mg/kg of 5% tramadol or 0.03 mL/Kg of iso- arm were evaluated every 5 minutes until the tonic sodium chloride).4 After a computerized onset of sensory and motor blockade. Sensory randomization, all patients were allocated into 1 blockade was tested with the pinprick test in the territory of distribution of each nerve and de- 1) group placebo (Group P) received the an- fined as sensory block = no sensation to pinprick esthetic mixture containing 0.4 mL/kg of 0.5% test or partial sensation to pressure versus no sen- levobupivacaine plus isotonic sodium chloride sory block = complete sensation to pinprick test, COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
TRAMADOL AND 0.5% LEVOBUPIVACAINE FOR SINGLE-SHOT INTERSCALENE BLOCK Table I.—Demographic and anthropometric data (mean±SD). while motor block was evaluated asking the pa- tient to raise the arm (circumflex nerve), to ab- The 3 groups were compared using the Mann- duct/adduct the thumb (radial/ulnar nerve), to Whitney U-test for quantitative variables and χ2 oppose the thumb (median nerve) and to flex the tests for qualitative variables. For comparison of forearm on the arm (musculocutaneous nerve).
parametric data three-way analysis of variance The anesthesia onset time was defined as the was applied and for non-parametric data Kruskal- interval between the end of the injection and Wal is analysis was fol owed by a Mann-Whitney the achievement of surgical anesthesia, defined U -test for three groups. Duration of analgesia as complete sensory and motor blocks as above was compared by long-rank test. A P value <0.05 described. The incidence of Horner’s syndrome was considered significant. Data were expressed If necessary, intraoperative analgesia was sup- plemented with incremental boluses of fentanyl i.v. from 50 mcg to a maximum dose of 100 mcg. In case a patient needed more than 100 mcg of fentanyl to complete surgery, the MIB There was no statistical difference in anthropo- was evaluated as failed block. If fentanyl sup- metric data between the three groups (Table I).
plementation was not sufficient to complete sur- gery, general anesthesia (GA) was administered Horner’s syndrome after MIB, without signifi- with propofol i.v. infusion and laryngeal mask cant differences among groups. Intraoperatively, airway. Intraoperatively, heart rate, systolic and heart rate, systolic and diastolic arterial pressure, diastolic arterial pressure, pulse oximetry and pulse oximetry and respiratory rate remained stable. No significant differences in the same pa- In the postoperative period a blinded observer rameters were noted among groups.
collected the Visual Analogue Score (VAS) for The onset times were not statistically different pain at rest and nausea/vomiting episodes every in the three groups (Table II).
2 hours. Duration of analgesia was defined as Intraoperative fentanyl consumptions were the time elapsed between drug injection and the comparable among the three groups: the mean first administration of 1g of i.v. acetaminophen fentanyl consumption in Group P was 90.9±20.2 postoperatively, occurring with a VAS > 3. We mcg, in Group TPN was 95.4±15.0 mcg, in also determined the VAS whenever a patient re- Group TIM was 96.4±13.3 mcg (P>0.05).
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quested assistance related to pain. Patients were Also the incidence of block failure was similar monitored for 24 hours for the presence of com- in the three groups: 2 patients in Group P, 2 pa- plications and side effects, including pruritus, tients in Group TPN and 1 patient in group TIM nausea/vomiting and hypotension. Nausea and/ required GA with propofol infusion and laryn- or vomiting were treated with levosulpiride 25 geal mask airway to complete surgery (P>0.05).
Mean duration of analgesia postoperatively The duration of analgesia was the primary was significantly longer in groups TIM and TPN outcome variable on which sample size estima- compared to Group P (Table II). Moreover, tion was based. The sample size of patients was Group TPN showed a longer duration of analge- calculated to detect a 10% effect of intervention sia postoperatively than Group TIM (Table II).
with a χ risk of 5% and a power of 80%.
Incidence of nausea and vomiting in the post- COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
TRAMADOL AND 0.5% LEVOBUPIVACAINE FOR SINGLE-SHOT INTERSCALENE BLOCK Table II.—Comparison of onset time and duration of analgesia between groups. A: comparison between Group P and Group TPN; B: comparison between Group P and Group TIM; C: comparison between Group TPN and Group TIM operative period did not show any significant of tramadol 100 mg to mepivacaine 1% for axil- difference among the three groups: we regis- lary plexus block prolonged sensory and motor tered 2 cases in Group P (5%), 4 cases in Group block compared with mepivacaine alone or axil- TIM (10%) and 3 cases in Group TPN (7.5%) lary block with tramadol 100 mg i.v.18 Robaux et al. demonstrated that tramadol extends the duration and improves the quality of postopera- tive analgesia in a dose-dependent fashion when Discussion
combined with mepivacaine 1.5% for brachial Our study shows that tramadol added to sin- plexus block.19 The incidence of adverse effects gle-shot interscalene block, either perineurally also increased with larger doses, but the side ef- or intramuscular, provides a longer duration fect profile remained acceptable up to 200 mg of postoperative analgesia when compared to tramadol in their study. However, a systemic interscalene block performed with 0.5% lev- tramadol group was not included in their study. obupivacaine alone. Moreover, when tramadol is More recently, Kaabachi et al. reported that 200 added as an adjuvant to single-shot interscalene mg tramadol prolong block duration and post- block, it provides a longer relief from postopera- operative analgesia when axillary block is per- tive pain than systemic tramadol, prolonging the formed with 1.5% lidocaine and epinephrine time-to-first-analgesic-request in patients under- 1/200000.20 However, a high dose of tramadol gone arthroscopic repair of rotator cuff tear.
was also associated with a delayed onset of an- Tramadol is known as an atypical analgesic esthesia, maybe related to the dilutional effect with some local anesthetic actions as wel as of tramadol added to the local anesthetic solu- central opioidergic, noradrenergic, and seroton- tion.20 Also Antonucci et al. evaluated the use ergic actions.1, 2 Many mechanisms have been of tramadol as adiuvant in carpal tunnel release advocated to explain tramadol’s peripheral ac- performed under axillary plexus block with tion on pain, including tramadol’s agonism at 0.75% ropivacaine 20 mL.21 Tramadol proved to peripheral a2 receptors (similarly to clonidine), provide a significative reduction of onset time, its agonism in the dorsal lamine of the spinal a prolongation of anesthesia and analgesia with cord through serotonin subtype 3 (5-HT3) re- lower incidence of side effects than clonidine ceptors and its postulated local anesthetic prop- No additional reproduction is author.
erties possibly by blocking K+ channels.16 Re- Other studies failed to demonstrate the effi- cently, Wang et al. have also demonstrated its cacy of tramadol as an adjunct to local anesthetic efficacy in antagonizing glutamate N-methyl- for brachial plexus block. In Kesimci et al., 42 D-aspartic acid (NMDA) receptors that are mL local anesthetic solution consisting of 0.75% known to be involved in the pathophysiology ropivacaine together with 100 mg tramadol was used for patients undergoing hand and forearm Although these promising results, direct com- surgery and axillary brachial plexus blockade.22 parison of studies involving tramadol for region- No effect of tramadol on block duration, onset al anesthesia is difficult, as very few studies have times and analgesia duration was seen. In a study by Broch and Breucking, brachial plexus block- Kapral et al. demonstrated that the addition ade was performed by adding 1.5 mg/kg trama- COPYRIGHT 2012 EDIZIONI MINERVA MEDICA
TRAMADOL AND 0.5% LEVOBUPIVACAINE FOR SINGLE-SHOT INTERSCALENE BLOCK dol or 1.5 mg/kg clonidine or placebo to 40 mL adverse events were reported in our study after of 1.5% prilocaine: a significant prolongation of the perineural administration of 1.5 mg/Kg of sensory and motor block was demonstrated only tramadol.
in the clonidine group, whether tramadol failed to prove its postulated efficacy.23 Also Sarsu et Conclusions
al. showed that adding 100 mg of tramadol to the combination of levobupivacaine and lido- In conclusion, when added to single-shot caine during axillary (40 mL of local anesthetic middle interscalene block performed with 0.5% solution) brachial plexus block was not effective levobupivacaine, tramadol extends the duration in shortening the block onset, lengthening the of postoperative analgesia without significant block in axillary brachial plexus blockade in pa- tients undergoing hand and forearm surgery.24 These contrasting results from previous litera- References
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Corresponding author: D. Ghisi, MD, Department of Anesthesia and Pain Therapy, Istituti Ospitalieri di Cremona, Viale Concordia 1, 26100 Cremona, Italy. E-mail: [email protected] This article is freely available at www.minervamedica.it No additional reproduction is author.

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