Pain, PostoperativePhase 4NCT05659823
Postoperative Pain After Caesarian Section
A Phase 4 study testing Bupivacaine-fentanyl-morphine elective group, Bupivacaine-fentanyl elective group and Bupivacaine-fentanyl emergency group in people with Pain, Postoperative and Pruritus, run by Conrad Arnfinn Bjørshol at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Pain, Postoperative, Pruritus, Nausea and Vomiting Following Administration of Anaesthetic Agent
- What is being tested?
- Bupivacaine-fentanyl-morphine elective group, Bupivacaine-fentanyl elective group and Bupivacaine-fentanyl emergency group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteNorway
- Study dates
- 2 Nov 2020to 5 Nov 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy parturient, term pregnancy, undergoing caesarian section
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.
Read the 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.
- Conditions
- Pain, Postoperative, Pruritus, Nausea and Vomiting Following Administration of Anaesthetic Agent, Consumption
- Being tested
- Bupivacaine-fentanyl-morphine elective group, Bupivacaine-fentanyl elective group, Bupivacaine-fentanyl emergency group
- Medical subject headings
- Pain, Postoperative, Pruritus, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine-fentanyl-morphine elective groupDrug
Guideline recommended analgesia in elective caesarian section.
Bupivacaine-fentanyl elective groupDrug
Current analgesia in elective caesarian section.
Bupivacaine-fentanyl emergency groupDrug
Current analgesia in emergency caesarian section.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Elective CS patients receiving current analgesia. Receives: Drug: Bupivacaine-fentanyl elective group |
| Intervention group | Experimental | Elective CS patients receiving guideline recommended analgesia. Receives: Drug: Bupivacaine-fentanyl-morphine elective group |
| Emergency group | Experimental | Emergency CS receiving current analgesia. Receives: Drug: Bupivacaine-fentanyl emergency group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain at postoperative care unit arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Measured: Immediately upon arrival at postoperative care unit
Postoperative pain at 30 minutes
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At maternity ward 20 hours after arrival
Secondary outcomes (6)
Postoperative nausea and vomiting at postoperative care unit
Present (yes/no) during stay at the postoperative care unit
Measured: During stay at postoperative care unit, estimated average 2 hours
Postoperative nausea and vomiting at maternity ward
Present (yes/no) during stay at the maternity ward
Measured: During stay at maternity ward, estimated average 22 hours
Postoperative pruritus at postoperative care unit
Present (yes/no) during stay at the postoperative care unit
Measured: During stay at postoperative care unit, estimated average 2 hours
Postoperative pruritus at maternity ward
Present (yes/no) during stay at the maternity ward
Measured: During stay at maternity ward, estimated average 22 hours
Postoperative additional oxycodone consumption at postoperative care unit
Number of mg of oxycodone administered as additional analgetics
Measured: During stay at postoperative care unit, estimated average 2 hours
Postoperative additional oxycodone consumption at maternity ward
Number of mg of oxycodone administered as additional analgetics
Measured: During stay at maternity ward, estimated average 22 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start2 Nov 2020
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conrad Arnfinn Bjørshol
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Conrad Arnfinn Bjørshol, Helse Stavanger HF
- Investigators
- Conrad A Bjørshol, PhD, MD, Study chair, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659823
- Sponsor's protocol ID
- 1399-2435
- Status last verified
- Apr 2023
- First submitted
- 23 Sep 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus
- ClinicalTrials.gov ID
- NCT05659823
- Acronym / sponsor ID
- 1399-2435
- Conditions
- Pain, Postoperative, Pruritus, Nausea and Vomiting Following Administration of Anaesthetic Agent, Consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Conrad Arnfinn BjørsholOther government
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Current treatment: Patients receive elective or emergency CS. Guideline recommended treatment: Only elective CS included.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Bupivacaine-fentanyl elective groupElective CS patients receiving current analgesia. |
| Intervention group | Experimental | Drug: Bupivacaine-fentanyl-morphine elective groupElective CS patients receiving guideline recommended analgesia. |
| Emergency group | Experimental | Drug: Bupivacaine-fentanyl emergency groupEmergency CS receiving current analgesia. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy parturient, term pregnancy, undergoing caesarian section
Key exclusion criteria (13 listed)
- Patient refusal
- Maternal heart or lung disease (not including mild asthma)
- Known or suspected obstructive sleep apnoea syndrome
- Pre-eclampsia
- Body mass index > 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine-fentanyl-morphine elective groupGuideline recommended analgesia in elective caesarian section. | Drug | Intervention group |
| Bupivacaine-fentanyl elective groupCurrent analgesia in elective caesarian section. | Drug | Control group |
| Bupivacaine-fentanyl emergency groupCurrent analgesia in emergency caesarian section. | Drug | Emergency group |
Primary outcome
Postoperative pain at postoperative care unit arrival
Time frame: Immediately upon arrival at postoperative care unit
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 30 minutes
Time frame: At postoperative care unit 30 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 60 minutes
Time frame: At postoperative care unit 60 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 90 minutes
Time frame: At postoperative care unit 90 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at 120 minutes
Time frame: At postoperative care unit 120 minutes after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward arrival
Time frame: Immediately upon arrival at maternity ward
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
Postoperative pain at maternity ward 4 hours after arrival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At maternity ward 20 hours after arrival
Postoperative pain during rest and movement measured by numeric rating scale (NRS).
6 secondary outcomes
Postoperative nausea and vomiting at postoperative care unit
Time frame: During stay at postoperative care unit, estimated average 2 hours
Postoperative nausea and vomiting at maternity ward
Time frame: During stay at maternity ward, estimated average 22 hours
Postoperative pruritus at postoperative care unit
Time frame: During stay at postoperative care unit, estimated average 2 hours
Postoperative pruritus at maternity ward
Time frame: During stay at maternity ward, estimated average 22 hours
Postoperative additional oxycodone consumption at postoperative care unit
Time frame: During stay at postoperative care unit, estimated average 2 hours
Postoperative additional oxycodone consumption at maternity ward
Time frame: During stay at maternity ward, estimated average 22 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conrad A Bjørshol, PhD, MD study chair
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine-fentanyl-morphine elective group, Bupivacaine-fentanyl elective group and Bupivacaine-fentanyl emergency group in people with Pain, Postoperative and Pruritus, run by Conrad Arnfinn Bjørshol at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain at postoperative care unit arrival (time frame: Immediately upon arrival at postoperative care unit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.