OBJECTIVE: To compare the efficacy and tolerability of dexamethasone-21-palmitate and mepivacaine alone and in combination in the acute treatment of facet syndrome. PATIENTS AND METHODS: A total of 157 patients requiring acute therapy for lumbar facet syndrome were treated with computed tomography (CT)-guided intra-articular infiltration of either an anti-inflammatory corticosteroid, a local anaesthetic or a combination of the two. Patients assigned to the first treatment group (n = 60) received the corticosteroid dexamethasone-21-palmitate (Lipotalon((R))); patients in the second group (n = 36) received the local anaesthetic mepivacaine (Meaverin((R))); patients in the third group (n = 61) received a combination of the two drugs. The study duration was from November 2002 until June 2003. RESULTS: In all three groups, values for compression pain, stress pain and rest pain improved significantly from baseline within 1 hour of injection: in the dexamethasone monotherapy group there was a 13% reduction in compression pain, 20% reduction in stress, and 22% reduction in rest pain; in the groups that received mepivacaine only or a combination of the two drugs there was a 63% and 60%, respectively, reduction of compression pain, 81% and 83%, respectively, reduction of stress pain, and 84% and 77%, respectively, reduction of rest pain. After 72 hours, improvements in these variables were significantly greater in patients treated with dexamethasone-21-palmitate (either as monotherapy or in combination therapy) than in patients treated with mepivacaine alone. In both groups treated with dexamethasone palmitate there was a 57% and 64%, respectively, reduction of compression pain, 70% and 66%, respectively, reduction of stress pain, and 75% and 64%, respectively, reduction of rest pain. In the mepivacaine monotherapy group there was a 17% reduction in compression pain, 26% reduction in stress pain and 13% reduction in rest pain. Both physicians and patients also rated the dexamethasone-21-palmitate-containing regimens as more effective than mepivacaine alone at 72 hours. Over the entire observation period, combination therapy was, on average, superior to both monotherapy regimens. The proportion of patients using concomitant NSAID medication after 3 days was reduced by 50% in the mepivacaine group and by 76% and 100%, respectively, in the dexamethasone-21-palmitate and combination therapy groups. CT-guided infiltration treatment was well tolerated and was associated with virtually no side effects in this study. CONCLUSION: CT-guided infiltration of dexamethasone palmitate, particularly in combination with mepivacaine, represents a safe and effective method for the acute therapy of lumbar facet syndrome. The combination is superior to the local anaesthetic alone with regard to pain reduction up to 3 days after injection.
RCT Entities:
OBJECTIVE: To compare the efficacy and tolerability of dexamethasone-21-palmitate and mepivacaine alone and in combination in the acute treatment of facet syndrome. PATIENTS AND METHODS: A total of 157 patients requiring acute therapy for lumbar facet syndrome were treated with computed tomography (CT)-guided intra-articular infiltration of either an anti-inflammatory corticosteroid, a local anaesthetic or a combination of the two. Patients assigned to the first treatment group (n = 60) received the corticosteroid dexamethasone-21-palmitate (Lipotalon((R))); patients in the second group (n = 36) received the local anaesthetic mepivacaine (Meaverin((R))); patients in the third group (n = 61) received a combination of the two drugs. The study duration was from November 2002 until June 2003. RESULTS: In all three groups, values for compression pain, stress pain and rest pain improved significantly from baseline within 1 hour of injection: in the dexamethasone monotherapy group there was a 13% reduction in compression pain, 20% reduction in stress, and 22% reduction in rest pain; in the groups that received mepivacaine only or a combination of the two drugs there was a 63% and 60%, respectively, reduction of compression pain, 81% and 83%, respectively, reduction of stress pain, and 84% and 77%, respectively, reduction of rest pain. After 72 hours, improvements in these variables were significantly greater in patients treated with dexamethasone-21-palmitate (either as monotherapy or in combination therapy) than in patients treated with mepivacaine alone. In both groups treated with dexamethasone palmitate there was a 57% and 64%, respectively, reduction of compression pain, 70% and 66%, respectively, reduction of stress pain, and 75% and 64%, respectively, reduction of rest pain. In the mepivacaine monotherapy group there was a 17% reduction in compression pain, 26% reduction in stress pain and 13% reduction in rest pain. Both physicians and patients also rated the dexamethasone-21-palmitate-containing regimens as more effective than mepivacaine alone at 72 hours. Over the entire observation period, combination therapy was, on average, superior to both monotherapy regimens. The proportion of patients using concomitant NSAID medication after 3 days was reduced by 50% in the mepivacaine group and by 76% and 100%, respectively, in the dexamethasone-21-palmitate and combination therapy groups. CT-guided infiltration treatment was well tolerated and was associated with virtually no side effects in this study. CONCLUSION: CT-guided infiltration of dexamethasone palmitate, particularly in combination with mepivacaine, represents a safe and effective method for the acute therapy of lumbar facet syndrome. The combination is superior to the local anaesthetic alone with regard to pain reduction up to 3 days after injection.