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| ID | Type | Description | Link |
|---|---|---|---|
| B300201421166 | Registry Identifier | FAGG |
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The surgical approach has changed.
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levobupivacaine | Active Comparator | 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). |
|
| Levobupivacaine + Dexmedetomidine | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of postoperative pain | Time between end of general anesthesia and a patients first demand of morphine registrated by PCIA. | 24 hours post procedure |
| Number of boluses morphine the patient asked for in the first 24 hours postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hilde Coppejans, MD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Edegem | Antwerp | 2650 | Belgium |
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| Levobupivacaine + Dexmedetomidine | Drug | Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique. |
|
Amount of times the patient pushed the PCIA button even during lockout time period
| 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. | 24 hours post procedure |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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