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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05659823
Other study ID # 1399-2435
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2, 2020
Est. completion date November 5, 2021

Study information

Verified date April 2023
Source Helse Stavanger HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date November 5, 2021
Est. primary completion date November 5, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine-fentanyl-morphine elective group
Guideline recommended analgesia in elective caesarian section.
Bupivacaine-fentanyl elective group
Current analgesia in elective caesarian section.
Bupivacaine-fentanyl emergency group
Current analgesia in emergency caesarian section.

Locations

Country Name City State
Norway Stavanger University Hospital Stavanger Rogaland

Sponsors (1)

Lead Sponsor Collaborator
Conrad Arnfinn Bjørshol

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary Postoperative pain at maternity ward arrival Postoperative pain during rest and movement measured by numeric rating scale (NRS). Immediately upon arrival at maternity ward
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary Postoperative pruritus at maternity ward Present (yes/no) during stay at the maternity ward During stay at maternity ward, estimated average 22 hours
Secondary 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
Secondary 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
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