Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perineural levobupivacaine with intravenous saline | Active Comparator | Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous saline. |
|
| Perineural dexamethasone in addition to levobupivacaine | Experimental | Patients will receive levobupivacaine-dexamethasone in interscalene brachial plexus block plus intravenous saline. |
|
| Intravenous dexamethasone with perineural levobupivacaine | Experimental | Patients will receive levobupivacaine plus saline in interscalene brachial plexus block in addition to intravenous dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perineural levobupivacaine | Drug | Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of postoperative analgesia | as measured by time to first analgesic requirement. | for 24 hour postoperatively |
| 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.
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nahla S El-Ebahnsawy, MD | Professor of Anesthesia and Surgical Intensive Care | Study Chair |
| Hazem E Moawed, MD | Assistant Professor of Anesthesia and Surgical Intensive Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University | Al Mansurah | Dakhlia | 050 | Egypt |
The raw data
from January 2020 to December 2020
Raw data and results with the registry
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind
| Perineural dexamethasone in addition to levobupivacaine | Drug | 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. |
|
| Intravenous dexamethasone with perineural levobupivacaine | Drug | 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. |
|
| 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:
| 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 |
| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided