Postoperative Pain After Caesarian Section

Conrad Arnfinn Bjørshol

Status and phase: Completed; Phase 4

Conditions: Nausea and Vomiting Following Administration of Anaesthetic Agent; Consumption; Pain, Postoperative; Pruritus

Treatments: Drug: Bupivacaine-fentanyl elective group; Drug: Bupivacaine-fentanyl-morphine elective group; Drug: Bupivacaine-fentanyl emergency group

Study type: Interventional

Funder types: Other

Identifiers

NCT05659823

1399-2435

Details and patient eligibility

About

To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.

Full 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.

Enrollment: 108 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 3 patient groups

Control group

Active Comparator group

Description:

Elective CS patients receiving current analgesia.

Treatment:

Drug: Bupivacaine-fentanyl elective group

Intervention group

Experimental group

Description:

Elective CS patients receiving guideline recommended analgesia.

Treatment:

Drug: Bupivacaine-fentanyl-morphine elective group

Emergency group

Experimental group

Description:

Emergency CS receiving current analgesia.

Treatment:

Drug: Bupivacaine-fentanyl emergency group