NCT05659823

Postoperative Pain After Caesarian Section

Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Conrad Arnfinn Bjørshol · Other Government
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain, Postoperative
• Pruritus
• Nausea and Vomiting Following Administration of Anaesthetic Agent
• Consumption

Interventions

Type	Name	Description
DRUG	Bupivacaine-fentanyl-morphine elective group	Guideline recommended analgesia in elective caesarian section.
DRUG	Bupivacaine-fentanyl elective group	Current analgesia in elective caesarian section.
DRUG	Bupivacaine-fentanyl emergency group	Current analgesia in emergency caesarian section.

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-11-05
• Completion: 2021-11-05
• First posted: 2022-12-21
• Last updated: 2023-04-18

Locations

1 site across 1 country: Norway