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| Name | Class |
|---|---|
| Maternite Regionale Universitaire | OTHER |
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The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous wound infiltration alone | Experimental | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. |
|
| Intrathecal moprhine alone | Active Comparator | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter. |
|
| Intrathecal morphine&wound infiltration | Experimental | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morphine consumption during the first 48 postoperative hours | at the 48th hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at rest and at mobilization | The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization | Every 4 hours during the first 48 postoperative hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florence VIAL, MD | Contact | + 33 3 83 34 43 67 | f.vial@maternite.chu-nancy.fr | |
| Philippe GUERCI, MD | Contact | +33 3 83 15 73 99 | p.guerci@chu-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Hervé BOUAZIZ, MD., PhD. | Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France | Study Chair |
| Florence VIAL, MD. | Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternité Régionale Universitaire (MRU) | Recruiting | Nancy | Lorraine | 54000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35274209 | Derived | Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10. |
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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 |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Morphine | Drug | Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period |
|
| Time to restoration of bowel function |
| within the first 48 postoperative hours |
| Verbal and Visual analog pain scores in the first standing position | at day 1 |
| Number of patients that required oral morphine | At the 24th and 48th hour |
| Number of patients that required local anesthetic rescue dose through the catheter | At the 24th and 48th hour |
| Postoperative rehabilitation survey | At the 48th hour |
| Occurrence of side effect | Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire | During the first 48 hours |
| Postoperative residual pain (DN4 survey) | At 3 months postoperatively |
| Philippe GUERCI, MD | Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE | Principal Investigator |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |