Postoperative Pain After Caesarian Section

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05659823
• Other study ID #: 1399-2435
• Status: Completed
• Phase: Phase 4
• 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
• 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)

Related Conditions & MeSH terms

• Consumption
• Nausea
• Pain, Postoperative
• Pruritus
• Vomiting

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