Intravenous Versus Perineural Effect Dexamethasone in Interscalene Nerve Block With Levobupivacaine

Study Overview
=================
Brief Summary
-----------------
Interscalene brachial plexus block can be used as an additive to general anaesthesia or as the primary anaesthetic for shoulder surgeries for pain management. The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries.

Detailed Description
-----------------
Dexamethasone had been shown to prolong the duration of postoperative analgesia when given as an adjuvant for peripheral nerve blocks. The investigators compared the effect of perineural versus intravenous dexamethasone on the prolongation of the action of levobupivacaine in ultrasound guided interscalene block for shoulder and upper arm surgeries. The study hypothesized that adding perineural dexamethasone to levobupivacaine in ultrasound guided interscalene block may be more superior to adding intravenous dexamethasone to levobupivacaine and levobupivacaine alone in shoulder and upper arm surgeries as regard analgesic effect, duration of analgesia and hemodynamic stability.

Official Title
-----------------
Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Drug: Perineural levobupivacaine
* Drug: Perineural dexamethasone in addition to levobupivacaine
* Drug: Intravenous dexamethasone with perineural levobupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status grade I and grade II. Exclusion Criteria: Patient refusal. Neuromuscular diseases (as myopathies, myasthenia gravies, …...) Hematological diseases, bleeding or coagulation abnormality. Psychiatric diseases. Local skin infection Sepsis at site of the block. Known intolerance to the study drugs. Body Mass Index > 40 Kg/m2 contralateral phrenic palsy pneumothorax pneumectomy severe COPD

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Perineural levobupivacaine with intravenous saline<br>Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline. | Drug: Perineural levobupivacaine<br>* Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.<br>|
| Experimental: Perineural dexamethasone in addition to levobupivacaine<br>Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline. | Drug: Perineural dexamethasone in addition to levobupivacaine<br>* Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.<br>|
| Experimental: Intravenous dexamethasone with perineural levobupivacaine<br>Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone. | Drug: Intravenous dexamethasone with perineural levobupivacaine<br>* Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia | as measured by time to first analgesic requirement. | for 24 hour postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Sensory block | Patients will be closely observed until 30 minutes after the end of local anesthetic injection. Block success will be defined as loss of sensation to pinprick in the C4 and C5 sensory dermatome distribution measured 30 minutes after the end of local anesthetic injection. sensory block will be assessed by pin prick test using a 3point scale: • Grade 0 = Normal sensation. Grade 1 = loss of sensation to pin prick (analgesia). Grade 2 = loss of sensation to touch (anaesthesia). Onset time for sensory block will be defined as the time interval between the end of local anaesthesia administration and complete sensory block (score 2). | For 30 min after injecting local anesthetic | 
| Duration of sensory block | defined as the time interval between complete sensory block (score 2) and complete resolution of anaesthesia on all nerves (score 0) | within 24 hours after the surgery. | 
| Onset time of motor block | Motor block will be determined according to the modified Bromage scale: Grade 0 = Normal motor function with full flexion and extention of elbow. Grade 1 = Decrease motor power. Grade 2 = Complete motor block. Onset time of motor block will be defined as the time interval between end of local anaesthetic administration and complete motor block (grade 2). | For 30 min after injecting local anesthic | 
| Duration of motor block | defined as the time interval between complete motor block (score 2) and complete recovery of motor function of the arm (score 0). | within 24 hours after the surge | 
| Intraoperative Heart rate changes | Heart rate changes | For 3 hours after surgery | 
| Intraoperative Mean arterial blood pressure changes | Mean arterial blood pressure changes | For 3 hours after surgery | 
| Intraoperative analgesic consumption | the intraoperative analgesic dose consumption would be calculated The investigators can use fentanyl as analgesic if the patient required during the surgery ( 50-100 mic) | For 3 hours after surgery | 
| Postoperative heart rate changes |  | For one hour after admission to the postoperative anesthesia care unit | 
| Postoperative Mean arterial blood pressure changes |  | For one hour after admission to the postoperative anesthesia care unit | 
| Postoperative peripheral oxygen saturation changes |  | For one hour after admission to the postoperative anesthesia care unit | 
| Pain score | The VAS is represented with straight line with one end has the anchor  no pain and it takes 0, while the other end of the line has the anchor  pain as bad as it could be and it takes 10. The patient will receive the rescue analgesic when the score is more than 4) | Pain after surgery will be assessed using VAS at 1,2,6,12 and 24 hours. | 
| Total analgesic need and the onset of first intravenous analgesia | Total analgesic need to rescue analgesic (pethidine) calculated by mg. And the onset of time for first intravenous analgesia during the 24 hours postoperative by hours. | After transportation of the patient from PACU up to 24 hours postoperative. | 
| Patient satisfaction: 2-point scale | concerning the procedure is assessed using a 2-point scale (1= satisfied, I would want the same anesthesia / analgesia method for the next surgery, 2= unsatisfied, I would want a different anesthesia / analgesia method for the next surgery). | first 24 hours postoperatively |