Postoperative Pain After Caesarian Section
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Control group Elective CS patients receiving current analgesia. |
Drug: Bupivacaine-fentanyl elective group
Current analgesia in elective caesarian section.
|
| Experimental: Intervention group Elective CS patients receiving guideline recommended analgesia. |
Drug: Bupivacaine-fentanyl-morphine elective group
Guideline recommended analgesia in elective caesarian section.
|
| Experimental: Emergency group Emergency CS receiving current analgesia. |
Drug: Bupivacaine-fentanyl emergency group
Current analgesia in emergency caesarian section.
|
Outcome Measures
Primary Outcome Measures
- 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).
- 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 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).
Secondary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stavanger University Hospital | Stavanger | Rogaland | Norway | 4068 |
Sponsors and Collaborators
- Conrad Arnfinn Bjørshol
Investigators
- Study Chair: Conrad A Bjørshol, PhD, MD, Helse Stavanger HF
Study Documents (Full-Text)
More Information
Publications
None provided.- 1399-2435