DexmedetomidineNCT06910644
Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy
A study testing Dexmedetomidine, Lidocaine and Isotonic saline in people with Dexmedetomidine and Lidocaine, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Dexmedetomidine, Lidocaine, Infusion
- What is being tested?
- Dexmedetomidine, Lidocaine and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 75 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.
Who cannot join
- Patient refusal.
- Known allergy to any of the study drugs.
- Those with hepatic or renal insufficiency.
- Patients who are running regularly on B blockers.
- α2 adrenergic agonists and sedatives.
- Psychoactive medications.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 12613
Mohamed E Abdel Fattah, MD, 00201284475792, mohamed-elsaid@cu.edu.eg
Samuel F Samy, MD
About this study
Official title: Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial
This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.
Read the detailed description
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.
- Conditions
- Dexmedetomidine, Lidocaine, Infusion, Adjuvants, General Anesthesia, Chronic Pain
- Being tested
- Dexmedetomidine, Lidocaine, Isotonic saline
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h.
LidocaineDrug
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 salineDrug
Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dexmedetomidine |
| 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. Receives: Drug: Lidocaine |
| Control group | Placebo comparator | Patients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs. Receives: Drug: Isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the chronic pain
Incidence of the chronic pain will be recorded.
Measured: 6 months postoperatively
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks postoperatively
Incidence of post-mastectomy pain syndrome
Incidence of post-mastectomy pain syndrome will be recorded.
Measured: 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 .
Measured: 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.
Measured: 12 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start5 Apr 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsaid Abdel Fattah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910644
- Sponsor's protocol ID
- AP2411-501-087-193
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Lidocaine Infusions as Adjuvants to General Anesthesia for Chronic Pain Management After Mastectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06910644
- Acronym / sponsor ID
- AP2411-501-087-193
- Conditions
- Dexmedetomidine, Lidocaine, Infusion, Adjuvants, General Anesthesia, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare dexmedetomidine and lidocaine infusions as adjuvants to general anesthesia for chronic pain management after mastectomy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group | Experimental | Drug: DexmedetomidinePatients 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 | Drug: LidocainePatients 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 | Drug: Isotonic salinePatients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 to 75 years.
- American Society of Anesthesiologists (ASA) physical status II.
- Scheduled for mastectomy with axillary dissection (either modified radical mastectomy with or without latissimus dorsi flap or conservative breast surgery) due to breast cancer.
Key exclusion criteria (6 listed)
- Patient refusal.
- Known allergy to any of the study drugs.
- Those with hepatic or renal insufficiency.
- Patients who are running regularly on B blockers.
- α2 adrenergic agonists and sedatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients will receive 1 μg/kg of intravenous dexmedetomidine over 10 min followed by an intravenous infusion of 0.5 μg/kg/h. | Drug | Dexmedetomidine group |
| LidocainePatients 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 group |
| Isotonic salinePatients will receive intravenous isotonic saline 0.9% in the same volume and manner as the study drugs. | Drug | Control group |
Primary outcome
Incidence of the chronic pain
Time frame: 6 months postoperatively
Incidence of the chronic pain will be recorded.
8 secondary outcomes
Time to the 1st rescue analgesia
Time frame: 48 hours postoperatively
Heart rate
Time frame: Till the end of operation (Up to 2 hours)
Mean arterial pressure
Time frame: Till the end of operation (Up to 2 hours)
Total morphine consumption
Time frame: 48 hours postoperatively
Degree of pain
Time frame: 12 weeks postoperatively
Incidence of post-mastectomy pain syndrome
Time frame: 6 months postoperatively
Activity level
Time frame: 12 weeks postoperatively
Assessment of quality of life
Time frame: 12 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Lidocaine and Isotonic saline in people with Dexmedetomidine and Lidocaine, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Abdel Fattah, MD (00201284475792, mohamed-elsaid@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the chronic pain (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.