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To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.
Control group (current analgesia, elective CS) is compared to current analgesia for emergency CS, and guideline recommended analgesia.
Current analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative: Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2 po, additional oxycodone 2,5 mg iv/5 mg po when needed.
Guideline recommended analgesia for CS:
Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05 mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.
Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Elective CS patients receiving current analgesia. |
|
| Intervention group | Experimental | Elective CS patients receiving guideline recommended analgesia. |
|
| Emergency group | Experimental | Emergency CS receiving current analgesia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine-fentanyl-morphine elective group | Drug | Guideline recommended analgesia in elective caesarian section. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain at postoperative care unit arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | Immediately upon arrival at postoperative care unit |
| Postoperative pain at 30 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 30 minutes after arrival |
| Postoperative pain at 60 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 60 minutes after arrival |
| Postoperative pain at 90 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 90 minutes after arrival |
| Postoperative pain at 120 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 120 minutes after arrival |
| Postoperative pain at maternity ward arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | Immediately upon arrival at maternity ward |
| Postoperative pain at maternity ward 4 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative nausea and vomiting at postoperative care unit | Present (yes/no) during stay at the postoperative care unit | During stay at postoperative care unit, estimated average 2 hours |
| Postoperative nausea and vomiting at maternity ward |
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Inclusion Criteria:
- Healthy parturient, term pregnancy, undergoing caesarian section
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Conrad A Bjørshol, PhD, MD | Helse Stavanger HF | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stavanger University Hospital | Stavanger | Rogaland | 4068 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2022 | Oct 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Intervention group | Oct 3, 2022 | Oct 3, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form: Intervention group | Oct 3, 2022 | Oct 3, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011537 | Pruritus |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
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| Bupivacaine-fentanyl elective group | Drug | Current analgesia in elective caesarian section. |
|
| Bupivacaine-fentanyl emergency group | Drug | Current analgesia in emergency caesarian section. |
|
| At maternity ward 4 hours after arrival |
| Postoperative pain at maternity ward 8 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 8 hours after arrival |
| Postoperative pain at maternity ward 12 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 12 hours after arrival |
| Postoperative pain at maternity ward 16 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 16 hours after arrival |
| Postoperative pain at maternity ward 20 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 20 hours after arrival |
Present (yes/no) during stay at the maternity ward
| During stay at maternity ward, estimated average 22 hours |
| Postoperative pruritus at postoperative care unit | Present (yes/no) during stay at the postoperative care unit | During stay at postoperative care unit, estimated average 2 hours |
| Postoperative pruritus at maternity ward | Present (yes/no) during stay at the maternity ward | During stay at maternity ward, estimated average 22 hours |
| Postoperative additional oxycodone consumption at postoperative care unit | Number of mg of oxycodone administered as additional analgetics | During stay at postoperative care unit, estimated average 2 hours |
| Postoperative additional oxycodone consumption at maternity ward | Number of mg of oxycodone administered as additional analgetics | During stay at maternity ward, estimated average 22 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012817 | Signs and Symptoms, Digestive |