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| Name | Class |
|---|---|
| anesthesia department | AMBIG |
| faculty of medicine | AMBIG |
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The duration of sensory block after single dose of long acting local anesthetics is not sufficient to avoid the postoperative use of opioids. Alpha-2 adrenoceptor agonists such as clonidine have been shown to increase the duration of peripheral nerve block. Dexmedetomidine is a more potent and selective α-2-adrenoceptor compared to clonidine. To the best of our knowledge, the use of Dexmedetomidine as adjuvant to local anesthetic was not previously reported for femoral nerve block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group B: control bupivacaine group | Placebo Comparator | Patient in this group will receive 25 ml bupivacaine 0.5% plus 0.5 ml normal saline peri-neurally and 0.5 ml subcutaneous normal saline. |
|
| Group B-peri-DEX: Peri-neural Dexmedetomidine | Experimental | Patients in this group will receive 25 ml of 0.5% bupivacaine plus 0.5 ml (50 microgram) Dexmedetomidine peri-neurally and 0.5 ml subcutaneous normal saline |
|
| Group B-sys-DEX:Systemic Dexmedetomidine | Active Comparator | Patients in this group will receive 25 ml bupivacaine plus 0.5 ml saline peri-neurally and 0.5 ml (50 microgram) subcutaneous Dexmedetomidine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block | Drug | ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously. After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure of this study will be the change of sensory block over time. | Over a period of 30 min after injection of the study medications, a blinded investigator will assess sensory block with pinprick test using a 3-point scale: 0 ═ complete loss of sensation, 1 ═ partial loss of sensation and 2 ═ normal sensation (10). Pinprick test will be done in comparison to the contralateral area at the sensory distribution of the femoral nerve | intraoperatively every 5 minutes for the first 30 minutes of the operation, then postoperatively every 2 hours for 24hours |
| Measure | Description | Time Frame |
|---|---|---|
| onset of motor and sensory block | The onset time of sensory and motor block will be: "the time elapsed between the end of injection and the development of complete block (score of 0 at all dermatomes or no movement of the quadriceps muscle. | up to 30 minutes after the end of injection |
| Measure | Description | Time Frame |
|---|---|---|
| duration of motor block | The duration of motor block will be defined as: "the time interval between the end of injection and the complete recovery of motor power of the quadriceps muscle)". | interval between time of injection and complete motor power recover |
| Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) ( |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anesthesia department-faculty of medicine-Cairo University | Cairo | Cairo Governorate | 02 | Egypt |
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Visual analogue pain scores (resting and dynamic) and Richmond Agitation-Sedation Score (RASS) (12) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively |
| 2hours post operative and for 24hours |
| time of 1st request of rescue analgesia | The time to the first request of rescue postoperative analgesic will be: "the time interval between the onset of successful sensory block and the first request to postoperative analgesia" | over the poatoperative 24hours |