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Postoperative Pain After Caesarian Section

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Bupivacaine-fentanyl-morphine elective group
Bupivacaine-fentanyl elective group
Bupivacaine-fentanyl emergency group
Sponsored by
Conrad Arnfinn Bjørshol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stavanger University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group

Intervention group

Emergency group

Arm Description

Elective CS patients receiving current analgesia.

Elective CS patients receiving guideline recommended analgesia.

Emergency CS receiving current analgesia.

Outcomes

Primary Outcome Measures

Postoperative pain at postoperative care unit arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 30 minutes
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 60 minutes
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 90 minutes
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 120 minutes
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 4 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 8 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 12 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 16 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 20 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).

Secondary Outcome Measures

Postoperative nausea and vomiting at postoperative care unit
Present (yes/no) during stay at the postoperative care unit
Postoperative nausea and vomiting at maternity ward
Present (yes/no) during stay at the maternity ward
Postoperative pruritus at postoperative care unit
Present (yes/no) during stay at the postoperative care unit
Postoperative pruritus at maternity ward
Present (yes/no) during stay at the maternity ward
Postoperative additional oxycodone consumption at postoperative care unit
Number of mg of oxycodone administered as additional analgetics
Postoperative additional oxycodone consumption at maternity ward
Number of mg of oxycodone administered as additional analgetics

Full Information

First Posted
September 23, 2022
Last Updated
April 17, 2023
Sponsor
Conrad Arnfinn Bjørshol
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1. Study Identification

Unique Protocol Identification Number
NCT05659823
Brief Title
Postoperative Pain After Caesarian Section
Official Title
Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2020 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Conrad Arnfinn Bjørshol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pruritus, Nausea and Vomiting Following Administration of Anaesthetic Agent, Consumption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Elective CS patients receiving current analgesia.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Elective CS patients receiving guideline recommended analgesia.
Arm Title
Emergency group
Arm Type
Experimental
Arm Description
Emergency CS receiving current analgesia.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl-morphine elective group
Intervention Description
Guideline recommended analgesia in elective caesarian section.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl elective group
Intervention Description
Current analgesia in elective caesarian section.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-fentanyl emergency group
Intervention Description
Current analgesia in emergency caesarian section.
Primary Outcome Measure Information:
Title
Postoperative pain at postoperative care unit arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
Immediately upon arrival at postoperative care unit
Title
Postoperative pain at 30 minutes
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At postoperative care unit 30 minutes after arrival
Title
Postoperative pain at 60 minutes
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At postoperative care unit 60 minutes after arrival
Title
Postoperative pain at 90 minutes
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At postoperative care unit 90 minutes after arrival
Title
Postoperative pain at 120 minutes
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At postoperative care unit 120 minutes after arrival
Title
Postoperative pain at maternity ward arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
Immediately upon arrival at maternity ward
Title
Postoperative pain at maternity ward 4 hours after arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At maternity ward 4 hours after arrival
Title
Postoperative pain at maternity ward 8 hours after arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At maternity ward 8 hours after arrival
Title
Postoperative pain at maternity ward 12 hours after arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At maternity ward 12 hours after arrival
Title
Postoperative pain at maternity ward 16 hours after arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At maternity ward 16 hours after arrival
Title
Postoperative pain at maternity ward 20 hours after arrival
Description
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Time Frame
At maternity ward 20 hours after arrival
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting at postoperative care unit
Description
Present (yes/no) during stay at the postoperative care unit
Time Frame
During stay at postoperative care unit, estimated average 2 hours
Title
Postoperative nausea and vomiting at maternity ward
Description
Present (yes/no) during stay at the maternity ward
Time Frame
During stay at maternity ward, estimated average 22 hours
Title
Postoperative pruritus at postoperative care unit
Description
Present (yes/no) during stay at the postoperative care unit
Time Frame
During stay at postoperative care unit, estimated average 2 hours
Title
Postoperative pruritus at maternity ward
Description
Present (yes/no) during stay at the maternity ward
Time Frame
During stay at maternity ward, estimated average 22 hours
Title
Postoperative additional oxycodone consumption at postoperative care unit
Description
Number of mg of oxycodone administered as additional analgetics
Time Frame
During stay at postoperative care unit, estimated average 2 hours
Title
Postoperative additional oxycodone consumption at maternity ward
Description
Number of mg of oxycodone administered as additional analgetics
Time Frame
During stay at maternity ward, estimated average 22 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conrad A Bjørshol, PhD, MD
Organizational Affiliation
Helse Stavanger HF
Official's Role
Study Chair
Facility Information:
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4068
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Postoperative Pain After Caesarian Section

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