Clinical trial NCT05659823: Postoperative Pain After Caesarian Section
Official title: Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Pruritus
Nausea and Vomiting Following Administration of Anaesthetic Agent
Consumption
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2022-12-21
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
Primary purpose: TREATMENT

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.

Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when needed.

Eligibility 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)

Primary outcomes:
measure: Postoperative pain at postoperative care unit arrival
timeFrame: Immediately upon arrival at postoperative care unit
measure: Postoperative pain at 30 minutes
timeFrame: At postoperative care unit 30 minutes after arrival
measure: Postoperative pain at 60 minutes
timeFrame: At postoperative care unit 60 minutes after arrival
measure: Postoperative pain at 90 minutes
timeFrame: At postoperative care unit 90 minutes after arrival
measure: Postoperative pain at 120 minutes
timeFrame: At postoperative care unit 120 minutes after arrival
measure: Postoperative pain at maternity ward arrival
timeFrame: Immediately upon arrival at maternity ward
measure: Postoperative pain at maternity ward 4 hours after arrival
timeFrame: At maternity ward 4 hours after arrival
measure: Postoperative pain at maternity ward 8 hours after arrival
timeFrame: At maternity ward 8 hours after arrival
measure: Postoperative pain at maternity ward 12 hours after arrival
timeFrame: At maternity ward 12 hours after arrival
measure: Postoperative pain at maternity ward 16 hours after arrival
timeFrame: At maternity ward 16 hours after arrival
measure: Postoperative pain at maternity ward 20 hours after arrival
timeFrame: At maternity ward 20 hours after arrival
Secondary outcomes:
measure: Postoperative nausea and vomiting at postoperative care unit
timeFrame: During stay at postoperative care unit, estimated average 2 hours
measure: Postoperative nausea and vomiting at maternity ward
timeFrame: During stay at maternity ward, estimated average 22 hours
measure: Postoperative pruritus at postoperative care unit
timeFrame: During stay at postoperative care unit, estimated average 2 hours
measure: Postoperative pruritus at maternity ward
timeFrame: During stay at maternity ward, estimated average 22 hours
measure: Postoperative additional oxycodone consumption at postoperative care unit
timeFrame: During stay at postoperative care unit, estimated average 2 hours
measure: Postoperative additional oxycodone consumption at maternity ward
timeFrame: During stay at maternity ward, estimated average 22 hours
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital
state: Rogaland
Study officials:
affiliation: Helse Stavanger HF
name: Conrad A Bjørshol, PhD, MD
role: STUDY_CHAIR
References: