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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000157-12 | EudraCT Number |
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Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or "PECS I block") would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | PECS block performed with Saline solution instead of local anesthetic |
|
| PECS group | Experimental | PECS block performed with Ropivacaine 3.75mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine (PECS bloc) | Drug | Ropivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption | Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery. | During the first 24 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| First administration of morphine | Time elapsed between tracheal extubation and first administration of morphine | During the first 24 postoperative hours |
| Post-operative nausea and/or vomiting | Number of nausea and/or vomiting episodes in the twenty-four hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benoit Tavernier, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Roger Salengro, CHU de Lille | Lille | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Placebo | Drug | 20 mL saline 0.9% |
|
|
| During the first 24 postoperative hours |
| Intra-operative opioids consumption | Sufentanil consumption during anesthesia | During procedure execution |
| Post-operative anti-emetic consumption | Consumption of anti-emetic drugs after surgery | During the first 24 postoperative hours |
| Post-operative pain | Evaluation of post-operative pain with a digital scale from 0 to 10 in the first twenty four hours after surgery | During the first 24 postoperative hours |
| 4-point sedation scale | using WHO Sedation scale - 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep | During the first two postoperative hours |
| Aldrete score | Aldrete Score is a medical scoring system for the measurement of recovery after anesthesia (post anesthesia) which includes activity, respiration, consciousness, blood circulation and color. | During the first two postoperative hours |
| Time physiological function recovery | Ability to drink, to eat, to urinate, to walk | During the first six postoperative hours after tracheal extubation |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |