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This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.
Chronic pain after breast cancer surgery is a significant problem that is expected to become more relevant because the number of patients undergoing breast cancer surgery is increasing owing to the longer survival associated with this surgery.
Lidocaine is the local anesthetic, which is used more often, and it is considered the prototype of amino-amide local anesthetics. Dexmedetomidine (DEX) is a highly selective agonist that acts by binding with presynaptic alpha 2-adrenergic receptor and then activating the negative feedback loop of the sympathetic nerve response, leading to inhibited norepinephrine release from the sympathetic terminals and decreased reflex activity of the sympathetic nervous.
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| 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 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 1.5mg/kg/h. |
|
| Control group | Placebo Comparator | Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs. |
|
| 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 0.5 μg/kg/h. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the chronic pain | Incidence of the chronic pain will be recorded. | 6 months postoperatively |
| 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 |
| Heart rate | Heart rate will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation. |
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Inclusion Criteria:
Exclusion Criteria:
Women scheduled for mastectomy
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed E Abdel Fattah, MD | Contact | 00201284475792 | mohamed-elsaid@cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | 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.
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| Lidocaine | Drug | Patients will receive a bolus of intravenous lidocaine 1.5mg/kg over 10 min followed by a continuous infusion of lidocaine 1.5mg/kg/h. |
|
| Isotonic saline | Drug | Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs. |
|
| Till the end of operation (Up to 2 hours) |
| Mean arterial pressure | Mean arterial pressure will be recorded before infusion (Baseline value), 5,10, 15, 30, 45 and 60 minutes and at the end of operation. | Till the end of operation (Up to 2 hours) |
| Total morphine consumption | Rescue analgesia of morphine 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses will be given if the visual analogue scale (VAS)>3. | 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 PACU, 1, 2, 4, 6, 8, 12, 18, 24, 36, 48 h,1, 2, 3, 4, 8, and 12 weeks postoperatively. | 12 weeks postoperatively |
| Incidence of post-mastectomy pain syndrome | Incidence of post-mastectomy pain syndrome will be recorded. | 6 months postoperatively |
| Activity level | The activity level will be assessed using the Barthel Activities of Daily Living scale (ADL) 2, 3, 4, 8 and 12 weeks postoperatively. This scale comprises 10 basic daily activities (bowel, bladder, feeding, toilet, bathing, dressing, grooming, walking, stairs and transfer) with each item scored as 0 = need complete help, 1 = need some help or 2 = need no help . | 12 weeks postoperatively |
| Assessment of quality of life | Quality of life will be assessed using the Flanagan Quality of Life Scale (QOLS), which is a 16-item (domain) questionnaire with each item scored from 1 to 7 points. The scale will be explained to the patients by the pain physician, and the total score will be calculated and recorded at the preoperative assessment (baseline) and at 2, 3, 4, 8 and 12 weeks postoperatively. | 12 weeks postoperatively |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| 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 |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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