A Phase 4 interventional study of Levobupivacaine and Levobupivacaine + Dexmedetomidine in Breast Cancer and Mastectomy, Modified Radical, sponsored by University Hospital, Antwerp. Terminated at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by University Hospital, Antwerp · Phase 4, Interventional, and Supportive care
Among 14 studies testing dexmedetomidine in Breast Neoplasms — 3 open to participants now, 3 under way, 1 of them phase 3. Dexmedetomidine · Breast Neoplasms.
Among the 14 studies testing dexmedetomidine in Breast Neoplasms, this one is the 12th largest by planned enrollment, is the only one that started in 2014, is one of 5 in phase 4, and was the 2nd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →3 of the 14 studies testing dexmedetomidine in Breast Neoplasms are open now, in 2 countries. Each count lists the studies.
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →14 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2014.
Median enrollment 94 across the 14 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
None of the 14 has an industry lead sponsor. The 10 most frequent:
University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 66 are open to participants now.
University Hospital, Antwerp has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing dexmedetomidine in Breast Neoplasms that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05439005Phase 3Institut CurieOpioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study. | 2027-06-06 |
Among the 14 studies testing dexmedetomidine in Breast Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
A double blind prospective randomized controlled trial in which the effect of single shot levobupivacaine 0,25% will be compared with the effect of levobupivacaine 0.25% in association with dexmedetomidine when performing an ultrasound guided modified pectoral nerve block , in patients undergoing a mastectomy with axillar procedure.
The difference in effect will be evaluated by monitoring the postoperative morphine consumption in both groups .
The hypothesis is that there is a significant decrease in morphine consumption during the first 24h postoperatively due to association of dexmedetomidine to the local anesthetic compared to the local anesthetic alone when performing a ultrasound guided modified pectoral nerve block. The morphine consumption will be the primary outcome parameter.
Women (18+, American Society of Anesthesiologists 1,2,3) undergoing a mastectomy with axillar procedure will be randomised and receive a ultrasound guided modified pectoral nerve block, if participants meet in- and exclusion criteria and provide written informed consent.
Using a two needle approach, ten milliliters of local anesthetic is injected under ultrasound guidance between the major and minor pectoral muscle and twenty milliliters between the minor pectoral and the serratus anterior muscle, on the side to be operated.
Participants receive intravenous Patient Controlled Analgesia with morphine and dehydrobenzperidol (1mg/ml morphine, 50µg dehydrobenzperidol/ml).
Furthermore every participant in the trial will receive ketorolac 0.5mg/kg three times a day and paracetamol four times 1g per day.
When the analgesia using the intravenous Patient Controlled Analgesia regime isn't sufficient, the anesthesiologist will titrate with morphine until pain free using a protocol (a bolus of 2mg morphine IV every ten minutes until pain free).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study Group 1 (Group L): patients undergoing an ultrasound guided modified pectoral nerve block (technique described by Blanco et al\[1\]) with levobupivacaine 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml) (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
Drug: Levobupivacaine
Study Group 2 (Group LD): patients undergoing an ultrasound guided modified pectoral nerve block (a technique described by Blanco et al\[1\]) with levobupivacaine 0.25% 29,5ml + Dexmedetomidine 50µg (0,5ml)with a total volume of 30ml. (10ml between major and minor pectoral muscle and 20ml between minor pectoral muscle and anterior serratus muscle at the level of the third or fourth rib).
Drug: Levobupivacaine + Dexmedetomidine
Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.
Also known as: Chirocaine
Drug pages: Levobupivacaine · Dexmedetomidine
Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.
Total postoperative opioid (morphine) consumption
Milligrams of morphine used by the patient registrated by patient controlled intravenous analgesia delivery device (PCIA) during 24 hours after surgery
Time frame: 24 hours post procedure
Onset of postoperative pain
Time between end of general anesthesia and a patients first demand of morphine registrated by PCIA.
Time frame: 24 hours post procedure
Number of boluses morphine the patient asked for in the first 24 hours postoperative
Amount of times the patient pushed the PCIA button even during lockout time period
Time frame: 24 hours post procedure
Number of effectively delivered morphine boluses in the first 24 hours postoperatively
Amount of times the patient pushed the PCIA button and morphine is delivered.
Time frame: 24 hours post procedure
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levobupivacaine · Dexmedetomidine
University Hospital, Antwerp →