An interventional study of Dexmedetomidine and Lidocaine in Dexmedetomidine, Lidocaine and Infusion, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
Drug: Dexmedetomidine
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.
Drug: Lidocaine
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Drug: Isotonic saline
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
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.
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
Incidence of the chronic pain
Incidence of the chronic pain will be recorded.
Time frame: 6 months postoperatively
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks postoperatively
Incidence of post-mastectomy pain syndrome
Incidence of post-mastectomy pain syndrome will be recorded.
Time frame: 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 .
Time frame: 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.
Time frame: 12 weeks postoperatively
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Dec 2025, 7 months after the start.
Of 1,209 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's planned 7 months is below that.
Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.
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Studies of the drugs tested here: Dexmedetomidine · Lidocaine