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
Not provided
Not provided
This study aims to compare the effect of intraoperative intravenous infusion of dexmedetomidine and lidocaine in the management of acute postoperative pain after mastectomy.
Postoperative pain control continues to remain suboptimal, despite multimodal analgesia regimes, minimally invasive surgical techniques, and enhanced recovery programs. Acute postoperative pain hinders patients' functional recovery and represents one of the greatest predictive factors for transition to chronic postsurgical pain.
Among adjuvants, dexmedetomidine, a highly selective α2 adrenoreceptor agonist, and lidocaine, a well-established local anesthetic, seem promising for this purpose.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine group | Experimental | Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of n 0.3-0.5 μg/kg/h. |
|
| Lidocaine group | Experimental | Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5-2 mg/kg/h. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of n 0.3-0.5 μg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to the 1st rescue analgesia | Time to the 1st rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated. | 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure | Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation. | Till the end of surgery (Up to 2 hours) |
| Heart rate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Wmone scheduled for modified radical mastectomy
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 12613 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine | Drug | Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5-2 mg/kg/h. |
|
Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45, and 60 minutes after the operation, and at the end of the operation.
| Till the end of surgery (Up to 2 hours) |
| Total morphine consumption | Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS)> 3 to be repeated after 30 min if pain persists until the VAS < 4. | 48 hours postoperatively |
| Degree of pain | Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable"). VAS will be assessed at post-anesthesia care unit (PACU), 2, 4, 8, 12, 24, 36, and 48 h postoperatively. | 48 hours postoperatively |
| Incidence of adverse events | Incidence of adverse events such as hypotension, bradycardia, nausea, vomiting, or any other complications will be recorded. | 48 hours postoperatively |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided