Postoperative Pain After Caesarian Section

NCT05659823 | Completed Phase 4

• 1 other identifier: 1399-2435
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (6)

• Postoperative nausea and vomiting at postoperative care unit

  During stay at postoperative care unit, estimated average 2 hours

• Postoperative nausea and vomiting at maternity ward

  During stay at maternity ward, estimated average 22 hours

• Postoperative pruritus at postoperative care unit

  During stay at postoperative care unit, estimated average 2 hours

• Postoperative pruritus at maternity ward

  During stay at maternity ward, estimated average 22 hours

• Postoperative additional oxycodone consumption at postoperative care unit

  During stay at postoperative care unit, estimated average 2 hours

Study Arms (3)

Control group

ACTIVE COMPARATOR

Elective CS patients receiving current analgesia.

Drug: Bupivacaine-fentanyl elective group

Intervention group

EXPERIMENTAL

Elective CS patients receiving guideline recommended analgesia.

Drug: Bupivacaine-fentanyl-morphine elective group

Emergency group

EXPERIMENTAL

Emergency CS receiving current analgesia.

Drug: Bupivacaine-fentanyl emergency group

Interventions

Bupivacaine-fentanyl-morphine elective group DRUG

Guideline recommended analgesia in elective caesarian section.

Intervention group

Bupivacaine-fentanyl elective group DRUG

Current analgesia in elective caesarian section.

Control group

Bupivacaine-fentanyl emergency group DRUG

Current analgesia in emergency caesarian section.

Emergency group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy parturient, term pregnancy, undergoing caesarian section

You may not qualify if:

• 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)

Sponsors & Collaborators

• Conrad Arnfinn Bjørshol: lead

Study Sites (1)

Stavanger University Hospital

Stavanger, Rogaland, 4068, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative; Pruritus; Nausea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms, Digestive

Study Officials

• Conrad A Bjørshol, PhD, MD

  Helse Stavanger HF

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior researcher

Model Details: Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: December 21, 2022
• Study Start: November 2, 2020
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

NO (1)