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| ID | Type | Description | Link |
|---|---|---|---|
| CER 12-112 | Other Identifier | Comité d'éthique de la recherche des HUG |
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| Name | Class |
|---|---|
| Domitille Dereu | UNKNOWN |
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Analgesia after cesarean section is still not satisfactory for many women. Even if pain reduction is sufficient with the technique of intrathecal morphine injection, side effects such as nausea and pruritus are common.
Since several years, an alternative technique has been studied, the "transversus abdominis plane (TAP)"-block. Here a local anesthetic is injected in the abdominal wall muscles, and this has been shown to give a similar analgesic effect compared to intrathecal morphine, with potentially less side effects.
With this study, we want to evaluate if the TAP-block yields indeed less side effects when compared with intrathecal morphine.
The study will be a prospective study with the patients randomized to either a group with intrathecal morphine or a group with TAP-block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morphine group | Active Comparator | spinal anesthesia with intrathecal morphine |
|
| TAP group | Experimental | TAP-block with ropivacaine and clonidine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| spinal anesthesia with intrathecal morphine | Other | in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added |
|
| Measure | Description | Time Frame |
|---|---|---|
| cumulative incidence of nausea and/or vomiting at 24 hours | Data for this endpoint will be gathered at 6h and 24h postoperatively from nurses' records in the recovery room (at 6h) and on the ward (at 24h), and counterchecked by asking the patient | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative incidence of pruritus at 24h | inquired directly from the patient at 6 and 24h | 24 h |
| Cumulative incidence of treated nausea and vomiting at 24h | (inquired directly from the patient at 6 and 24h). |
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Inclusion Criteria:
Subjects must satisfy all of the following criteria to be enrolled into the study:
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Domitille Dereu, MD | HUG | Principal Investigator |
| Domitille Dereu, MD | HUG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Genève | Geneva | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31274545 | Derived | Dereu D, Savoldelli GL, Mercier Y, Combescure C, Mathivon S, Rehberg B. The impact of a transversus abdominis plane block including clonidine vs. intrathecal morphine on nausea and vomiting after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2019 Aug;36(8):575-582. doi: 10.1097/EJA.0000000000001013. |
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treatment versus placebo
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pharmacy providing identical sets of study drugs and placebo, computerized random sequence generation, sequence held by the pharmacy until study completion
| TAP-block with ropivacaine and clonidine | Other |
|
| 24h |
| Cumulative incidence of sedation at 6 and 24h. | Sedation defined as an observer's assessment of alertness and sedation (OAAS) score lower than 4 | 24h |
| Cumulative incidence of arterial hypotension | defined as a systolic blood pressure of less than 100 mmHg for longer than 5 minutes (from nurse records at 6 and 24h) | 24h |
| Cumulative incidence of bradycardia | defined as a heart rate of less than 50/min for longer than 5 minutes (from nurse records at 6 and 24h) | 24h |
| Cumulative incidence of respiratory depression | defined as a respiratory frequency of less than 8/min for longer than 5 minutes (from nurse records at 6 and 24h | 24h |
| Cumulative morphine consumption at 24 hours | (recorded in the memory of the patient controlled analgesia (PCA) pump). | 24h |
| Time until first PCA request | (recorded in the memory of the PCA pump | 24h |
| Pain score at rest at 6, 24 and 48 hours postoperatively | using the NRS scale (0-10) | 48h |
| Pain score on movement | at 24 and 48 hours postoperatively (using the numerical rating scale (NRS 0-10)). | 48h |
| Maternal satisfaction at 24 and 48 hours postoperatively | measured on a numeric rating scale (at 6h) and with the questionnaire "quality of recovery" (QoR40) at 24 and 48h | 48h |
| persistent pain at 3 and 6 months postoperatively | Pain at rest, 0-10 pain scale; Pain on movement, 0-10 pain scale; Yes/no for scar pain;Yes/no for analgesic use | 6 months |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D000077212 | Ropivacaine |
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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