Consumption, Nausea and Vomiting Following Administration of Anaesthetic Agent, Pain, Postoperative, Pruritus
Conditions
Brief summary
To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.
Detailed description
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.
Interventions
DRUGBupivacaine-fentanyl-morphine elective group
Guideline recommended analgesia in elective caesarian section.
DRUGBupivacaine-fentanyl elective group
Current analgesia in elective caesarian section.
DRUGBupivacaine-fentanyl emergency group
Current analgesia in emergency caesarian section.
Sponsors
Conrad Arnfinn Bjørshol
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
\- Healthy parturient, term pregnancy, undergoing caesarian section
Exclusion criteria
* Patient refusal * Maternal heart or lung disease (not including mild asthma) * Known or suspected obstructive sleep apnoea syndrome * Pre-eclampsia * Body mass index \> 40 * Indulin-dependent diabetes mellitus * Contraindications to ibuprofen, dexamethasone or morphine * Chronic pain * Neurological disease * Drug abuse * Age \< 18 years * American Society of Anesthesiologists (ASA) 3 * Patients receiving other forms of anaesthesia (epidural or general)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain at maternity ward 20 hours after arrival | At maternity ward 20 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at 120 minutes | At postoperative care unit 120 minutes after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at maternity ward arrival | Immediately upon arrival at maternity ward | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at maternity ward 4 hours after arrival | At maternity ward 4 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at maternity ward 8 hours after arrival | At maternity ward 8 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at maternity ward 12 hours after arrival | At maternity ward 12 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at maternity ward 16 hours after arrival | At maternity ward 16 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at postoperative care unit arrival | Immediately upon arrival at postoperative care unit | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at 30 minutes | At postoperative care unit 30 minutes after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at 60 minutes | At postoperative care unit 60 minutes after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
| Postoperative pain at 90 minutes | At postoperative care unit 90 minutes after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting at maternity ward | During stay at maternity ward, estimated average 22 hours | Present (yes/no) during stay at the maternity ward |
| Postoperative pruritus at postoperative care unit | During stay at postoperative care unit, estimated average 2 hours | Present (yes/no) during stay at the postoperative care unit |
| Postoperative pruritus at maternity ward | During stay at maternity ward, estimated average 22 hours | Present (yes/no) during stay at the maternity ward |
| Postoperative additional oxycodone consumption at postoperative care unit | During stay at postoperative care unit, estimated average 2 hours | Number of mg of oxycodone administered as additional analgetics |
| Postoperative additional oxycodone consumption at maternity ward | During stay at maternity ward, estimated average 22 hours | Number of mg of oxycodone administered as additional analgetics |
| Postoperative nausea and vomiting at postoperative care unit | During stay at postoperative care unit, estimated average 2 hours | Present (yes/no) during stay at the postoperative care unit |
Countries
Norway
Outcome results
None listed