Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Postoperative pain at 30 minutes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts 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)
Arms & Interventions
Control group
Elective CS patients receiving current analgesia.
Intervention: Bupivacaine-fentanyl elective group (Drug)
Intervention group
Elective CS patients receiving guideline recommended analgesia.
Intervention: Bupivacaine-fentanyl-morphine elective group (Drug)
Emergency group
Emergency CS receiving current analgesia.
Intervention: Bupivacaine-fentanyl emergency group (Drug)
Outcomes
Primary Outcomes
Postoperative pain at 30 minutes
Time Frame: 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
Time Frame: At postoperative care unit 60 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 8 hours after arrival
Time Frame: 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
Time Frame: At maternity ward 12 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward arrival
Time Frame: Immediately upon arrival at maternity ward
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 16 hours after arrival
Time Frame: 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
Time Frame: Immediately upon arrival at postoperative care unit
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 90 minutes
Time Frame: At postoperative care unit 90 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 120 minutes
Time Frame: 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 4 hours after arrival
Time Frame: At maternity ward 4 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 20 hours after arrival
Time Frame: At maternity ward 20 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Secondary Outcomes
- Postoperative nausea and vomiting at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative pruritus at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative additional oxycodone consumption at maternity ward(During stay at maternity ward, estimated average 22 hours)
- Postoperative pruritus at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
- Postoperative additional oxycodone consumption at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
- Postoperative nausea and vomiting at postoperative care unit(During stay at postoperative care unit, estimated average 2 hours)
Investigators
Conrad Arnfinn Bjørshol
Senior researcher
Helse Stavanger HF