Postoperative Pain After Caesarian Section

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Bupivacaine-fentanyl-morphine elective group
* Drug: Bupivacaine-fentanyl elective group
* Drug: Bupivacaine-fentanyl emergency group


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Elective CS patients receiving current analgesia. | Drug: Bupivacaine-fentanyl elective group<br>* Current analgesia in elective caesarian section.<br>|
| Experimental: Intervention group<br>Elective CS patients receiving guideline recommended analgesia. | Drug: Bupivacaine-fentanyl-morphine elective group<br>* Guideline recommended analgesia in elective caesarian section.<br>|
| Experimental: Emergency group<br>Emergency CS receiving current analgesia. | Drug: Bupivacaine-fentanyl emergency group<br>* Current analgesia in emergency caesarian section.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain at postoperative care unit arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | Immediately upon arrival at postoperative care unit | 
| Postoperative pain at 30 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 30 minutes after arrival | 
| Postoperative pain at 60 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 60 minutes after arrival | 
| Postoperative pain at 90 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 90 minutes after arrival | 
| Postoperative pain at 120 minutes | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At postoperative care unit 120 minutes after arrival | 
| Postoperative pain at maternity ward arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | Immediately upon arrival at maternity ward | 
| Postoperative pain at maternity ward 4 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 4 hours after arrival | 
| Postoperative pain at maternity ward 8 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 8 hours after arrival | 
| Postoperative pain at maternity ward 12 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 12 hours after arrival | 
| Postoperative pain at maternity ward 16 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 16 hours after arrival | 
| Postoperative pain at maternity ward 20 hours after arrival | Postoperative pain during rest and movement measured by numeric rating scale (NRS). | At maternity ward 20 hours after arrival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting at postoperative care unit | Present (yes/no) during stay at the postoperative care unit | During stay at postoperative care unit, estimated average 2 hours | 
| Postoperative nausea and vomiting at maternity ward | Present (yes/no) during stay at the maternity ward | During stay at maternity ward, estimated average 22 hours | 
| Postoperative pruritus at postoperative care unit | Present (yes/no) during stay at the postoperative care unit | During stay at postoperative care unit, estimated average 2 hours | 
| Postoperative pruritus at maternity ward | Present (yes/no) during stay at the maternity ward | During stay at maternity ward, estimated average 22 hours | 
| Postoperative additional oxycodone consumption at postoperative care unit | Number of mg of oxycodone administered as additional analgetics | During stay at postoperative care unit, estimated average 2 hours | 
| Postoperative additional oxycodone consumption at maternity ward | Number of mg of oxycodone administered as additional analgetics | During stay at maternity ward, estimated average 22 hours |