Clinical trial

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

Name

1399-2435

Description

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

Trial arms

Trial start

2020-11-02

Estimated PCD

2021-11-05

Trial end

2021-11-05

Status

Completed

Phase

Early phase I

Treatment

Bupivacaine-fentanyl-morphine elective group

Guideline recommended analgesia in elective caesarian section.

Arms:

Intervention group

Bupivacaine-fentanyl elective group

Current analgesia in elective caesarian section.

Arms:

Control group

Bupivacaine-fentanyl emergency group

Current analgesia in emergency caesarian section.

Arms:

Emergency group

Size

108

Primary endpoint

Postoperative pain at postoperative care unit arrival

Immediately upon arrival at postoperative care unit

Postoperative pain at 30 minutes

At postoperative care unit 30 minutes after arrival

Postoperative pain at 60 minutes

At postoperative care unit 60 minutes after arrival

Postoperative pain at 90 minutes

At postoperative care unit 90 minutes after arrival

Postoperative pain at 120 minutes

At postoperative care unit 120 minutes after arrival

Postoperative pain at maternity ward arrival

Immediately upon arrival at maternity ward

Postoperative pain at maternity ward 4 hours after arrival

At maternity ward 4 hours after arrival

Postoperative pain at maternity ward 8 hours after arrival

At maternity ward 8 hours after arrival

Postoperative pain at maternity ward 12 hours after arrival

At maternity ward 12 hours after arrival

Postoperative pain at maternity ward 16 hours after arrival

At maternity ward 16 hours after arrival

Postoperative pain at maternity ward 20 hours after arrival

At maternity ward 20 hours after arrival

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 108, 'type': 'ACTUAL'}}

Updated at

2023-04-18

1 organization

2 products

5 indications

Organization

Conrad Arnfinn Bjørshol

Product

Bupivacaine + Fentanyl + Morphine

Indication

Pain

Indication