Perineural Low-dose Dexamethasone Added to Infraclavicular Block Anesthesia

Study Overview
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Brief Summary
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Dexamethasone has an evidence-based indication in postoperative emesis prophylaxy and as a antiinflammatory steroid. Although the perineural administration is off-label, several studies recognised its analgetic action as an adjuvant for peripheral nerves blockade, permitting to reduce the concentration of the local anesthetics and extending the sensory and motor block.Questions remain concerning the mechanism of action, optimal dose, the lack/degree of toxicity and the comparison with intravenous administration.The aim of this prospective randomized controlled study is to investigate the efficacy of analgesia with 4 mg or 2 mg Dexamethasone added to a combination of ropivacaine 0,5% and lidocaine 1% in vertical infraclavicular blockade (VIB) anesthesia for upper limb surgery.

Detailed Description
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The investigators conducted a prospective randomized controlled study in 150 patients American Society of Anesthesiologists (ASA) score I-III scheduled for upper limb surgery , divided in 3 groups: group A received anesthesia VIB block with ropivacaine 0,5% 100 mg +lidocaine 1%+1 ml saline; group B received VIB block with ropivacaine 0,5% 100 mg +lidocaine 1% + 2 mg dexamethasone; group C received ropivacaine 0,5% 100 mg +lidocaine 1% + 4 mg dexamethasone.The anesthesiologist may use the ultrasound for visual guidance, but should also use the nerve stimulator in order to maintain the homogeneity of the procedure. Intraoperative sedation was provided with intermittent bolus 10-20 mg IV Propofol. Postoperatively all patients received the same analgetic protocol when Visual Analog Pain Scale (VAS) over 3 with IV Perfalgan and Lornoxicam 8 mg/12 hours for 24 hours. If after 30 minutes VAS is still over 3, a loading dose of morphine 0,05 mg/kg should be administered. At first analgetic request, the nurse conducts an ice-probe test to both arms and will note the answer: same cold, slightly burn, burn, aching with the reason to test the potentially hyperalgesia effect related to ropivacaine. The data recorded are: time to first analgetic use, VAS at block regression, ice-probe test, motor and sensitive block duration, glycemic variations at 4 h, neurological complications immediately after block, total morphine consumption.

Official Title
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Analgetic Efficiency of Single-shot Perineural Low Dose Dexamethasone Added to Infraclavicular Block Anesthesia for Upper Limb Surgery

Conditions
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Postoperative Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I-III, BMI<40, non-anemic Exclusion Criteria: High risk grade hypertension, chronic renal failure, known allergy to local anesthetic or NSAIDs, chronic treatment with steroids, drugs dependency, history of diabetes mellitus, ulcer or chronic gastritis, infection on the puncture site, chronic obstructive pulmonary disease, neuropathy at the surgical level

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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>VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+1 ml saline=21 ml. 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 0.05 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: Ropivacaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Morphine Sulfate ER;Drug: Lidocaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;|
| Active Comparator: Group B<br>VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+2 mg dexamethasone=21 ml. 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 0.05 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<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Decadron;Drug: Ropivacaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Morphine Sulfate ER;Drug: Lidocaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;|
| Active Comparator: Group C<br>VIB block with ropivacaine 0,5%100 mg+lidocaine1%100 mg+4 mg dexamethasone=21 ml. 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 0.05 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<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Decadron;Drug: Ropivacaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Naropin;Drug: Paracetamol<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Perfalgan;Drug: Morphine<br>* After the block regression, at the first analgetic request the patients received the same analgesia protocol<br>* Other names: Morphine Sulfate ER;Drug: Lidocaine<br>* One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation<br>* Other names: Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensory block duration | The time in minutes measured between VIB block to first analgetic request | First 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor block duration | The time in minutes measured between VIB block to complete movement of the hand | First 24 hours postoperatively | 
| Glycemic variations at 4 hours post-VIB block | Determination of blood sugar level | First 4 hours postoperatively | 
| Number of patients opioid free analgesia | Number of reported patients with no need opioid analgesia | First 24 hours postoperatively | 
| VAS at the block regression | VAS evaluation on the VAS scale (0 - no pain, 10 - the worst pain possible ) | First 24 hours postoperatively | 
| Cutaneous temperature ice-probe | The cold sensation on ice-probe test to both arms could be the same or burn likely | First 24 hours postoperatively | 
| Total morphine consumption at 24 hours | Cumulative morphine administration in milligrams | First 24 hours postoperatively |