Perineural Dexamethasone in Femural Nerve Block After Ligament Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Perineural Dexamethasone Administered in Femural Nerve Block After Anterior Cruciate Ligament Reconstruction

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Dexamethasone phosphate
* Drug: Paracetamol
* Drug: Morphine
* Drug: Lidocaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III BMI<40 Exclusion Criteria: High risk grade hypertension Chronic renal failure Known allergy to drugs used Chronic treatment with steroids Drugs dependency History of diabetes mellitus Ulcer or chronic gastritis Infection on the puncture site Neuropathy at the surgical level Coagulopathy Requesting another type of anesthesia Fear to sign informed consent By-pass aorto-femoral

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group A<br>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. | Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Morphine Sulfate;Drug: Lidocaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;Drug: Ropivacaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;|
| Active Comparator: Group B<br>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. | Drug: Dexamethasone phosphate<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Decadron;Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Morphine Sulfate;Drug: Lidocaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;Drug: Ropivacaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;|
| Active Comparator: Group C<br>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. | Drug: Dexamethasone phosphate<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Decadron;Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the analgesia protocol<br>* Other names: Morphine Sulfate;Drug: Lidocaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;Drug: Ropivacaine<br>* At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the total amount of morphine | the morphine administered in milligrams | At 24 hour postoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |