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The effect of perineural dexamethasone administered as an adjuvant in prolonging the duration of analgesia continues to be under debate. The investigators performed a prospective randomized study to evaluate the effect of perineural dexamethasone in different concentrations in postoperative analgesia in femoral nerve block for anterior cruciate ligament reconstruction.
After Ethics committee approval, 75 patients American Society of Anesthesiologists score (ASA) I-III were randomized at the end of surgery into 3 groups of 25 patients each who underwent femoral nerve block: group A with 20 ml ropivacaine 0,5% and 20 ml lidocaine 1%; group B with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 4 mg dexamethasone; group C with 20 ml ropivacaine 0,5%, 20 ml lidocaine 1% and 8 mg dexamethasone.
All groups received postoperative analgesia when visual analog scale (VAS) over 3 (by request), with IV Perfalgan 1 g and morphine (loading dose 0.1 mg/kg and titration until VAS under 3, followed by subcutaneous (SC) administration of 1/2 of total loading dose on demand for the following 24 hours (h) .
Efficacy was evaluated by the time interval from performing the block until the first analgesic dose required, the total amount of morphine in the first 24 h postoperative, the patient satisfaction and the neurological side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Placebo Comparator | After the spinal anesthesia regressed, the investigators performed a single shot femoral block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
|
| Group B | Active Comparator | After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg + lidocaine 1% 200 mg and 4 mg dexamethasone phosphate. After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
|
| Group C | Active Comparator | After the spinal anesthesia regressed, the investigators performed a single shot femural block with ropivacaine 0,5% 200 mg+ lidocaine 1% 200 mg and 8 mg dexamethasone phosphate.After the block regression, at the first analgetic request the patients received the analgesia protocol was started for 24 h with paracetamol 1 g IV every 8 h and lornoxicam 8 mg PO every 12 h; if VAS was still over 3 after 30 min, morphine was given as a loading bolus of 0.1 mg/kg IV supplemented with 2 mg IV every 5 minutes until VAS <3. After 2 h morphine was administered SC ½ of the total loading dose at request. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone phosphate | Drug | At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the total amount of morphine | the morphine administered in milligrams | At 24 hour postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| the patient satisfaction | evaluation of satisfaction by a questionnaire | At 24 hour postoperative |
| the number of patients with neurological motility side effects | Following the postoperative motility of operated lower limb by Bromage scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioan Cristian Stoica, Prof | Foisor Orthopedics Clinical Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foisor Orthopedics Clinical Hospital | Bucharest | 021382 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25774458 | Result | Huynh TM, Marret E, Bonnet F. Combination of dexamethasone and local anaesthetic solution in peripheral nerve blocks: A meta-analysis of randomised controlled trials. Eur J Anaesthesiol. 2015 Nov;32(11):751-8. doi: 10.1097/EJA.0000000000000248. | |
| 21519308 | Result | Williams BA, Hough KA, Tsui BY, Ibinson JW, Gold MS, Gebhart GF. Neurotoxicity of adjuvants used in perineural anesthesia and analgesia in comparison with ropivacaine. Reg Anesth Pain Med. 2011 May-Jun;36(3):225-30. doi: 10.1097/AAP.0b013e3182176f70. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| C004180 | dexamethasone 21-phosphate |
| D002123 | Calcium Dobesilate |
| D000082 | Acetaminophen |
| D009020 | Morphine |
| D008012 | Lidocaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| Paracetamol | Drug | After the block regression, at the first analgetic request the patients received the analgesia protocol |
|
|
| Morphine | Drug | After the block regression, at the first analgetic request the patients received the analgesia protocol |
|
|
| Lidocaine | Drug | At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation |
|
|
| Ropivacaine | Drug | At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation |
|
|
| At 24 h postoperative |
| duration of analgesia | the time interval from performing the block until the first analgesic dose required at VAS >3 (0 - no pain, 10 - the worst pain possible | the first 24 hours |
| the number of patients with neurological sensibility side effects | Following postoperative sensibility of operated lower limb by pinprick test | At 21 days postoperative |
| 25485150 | Result | De Oliveira GS Jr, Castro Alves LJ, Nader A, Kendall MC, Rahangdale R, McCarthy RJ. Perineural dexamethasone to improve postoperative analgesia with peripheral nerve blocks: a meta-analysis of randomized controlled trials. Pain Res Treat. 2014;2014:179029. doi: 10.1155/2014/179029. Epub 2014 Nov 18. |
| 21956081 | Result | Brummett CM, Williams BA. Additives to local anesthetics for peripheral nerve blockade. Int Anesthesiol Clin. 2011 Fall;49(4):104-16. doi: 10.1097/AIA.0b013e31820e4a49. |
| 24781562 | Result | Williams BA, Schott NJ, Mangione MP, Ibinson JW. Perineural dexamethasone and multimodal perineural analgesia: how much is too much? Anesth Analg. 2014 May;118(5):912-4. doi: 10.1213/ANE.0000000000000203. No abstract available. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |