Post Caesarean AnalgesiaPhase 3ApcisaalNCT02264821
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
A Phase 3 study testing ropivacaine infiltration and intrathecal morphine in people with Post Caesarean Analgesia, run by Dr Madeleine Wilwerth at 1 site in Belgium.
Trial summary
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Caesarean Analgesia
- What is being tested?
- ropivacaine infiltration and intrathecal morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2012to Aug 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.
Who cannot join
- Refusal of the patient or contra-indication to locoregional anesthesia
- Allergy to the products used
- ASA 3
- ASA 4
- Sleep apnea syndrome and/or obesity (BMI > 35)
- Size inferior to 155cm
- existence of a language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
Read the detailed description
Double blind, 3 groups
- Control group: Rachi 0,1 ml saline, Infusion 300ml saline
- Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
- Group KT: 0,1 ml saline/300 ml naropin 0.2%
- Conditions
- Post Caesarean Analgesia
- Being tested
- ropivacaine infiltration, intrathecal morphine, placebo
- Keywords
- analgesia, caesarean, wound infiltration, intrathecal morphine.
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine infiltrationDrug
Also called Naropin, local anesthetic
wound infiltration
intrathecal morphineDrug
Also called spinal morphine
100 µg added to the spinal anaesthesia
placeboDrug
Also called Nacl 0,9 %, saline solution
placebo in spinal anaesthesia and in wound infiltration
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine infiltration | Experimental | ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline Receives: Drug: ropivacaine infiltration |
| rachi morphine | Experimental | 100 µg intrathecal morphine and saline infiltration Receives: Drug: intrathecal morphine |
| placebo | Placebo comparator | intrathecal saline and saline infiltration Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Effective Analgesia
T0 until first request of morphine PCAIV
Measured: 30 hours after spinal injection T0
Morphine Consumption
Morphine consumption with PCAIV
Measured: 30 hours after spinal injection T0
Secondary outcomes (1)
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?
Measured: 30 hours after spinal injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startFeb 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Caesarean AnalgesiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Madeleine Wilwerth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Madeleine Wilwerth, Brugmann University Hospital
- Investigators
- Philippe Van der Linden, PhD, MD, Study director, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264821
- Sponsor's protocol ID
- Apcisaal 01
- Acronym
- Apcisaal
- Status last verified
- May 2015
- First submitted
- 25 Aug 2014
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
- ClinicalTrials.gov ID
- NCT02264821
- Acronym / sponsor ID
- Apcisaal / Apcisaal 01
- Conditions
- Post Caesarean Analgesia
- Keywords
- analgesia, caesarean, wound infiltration, intrathecal morphine.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Dr Madeleine WilwerthUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
Detailed description
Double blind, 3 groups
- Control group: Rachi 0,1 ml saline, Infusion 300ml saline
- Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
- Group KT: 0,1 ml saline/300 ml naropin 0.2%
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ropivacaine infiltration | Experimental | Drug: ropivacaine infiltrationropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline |
| rachi morphine | Experimental | Drug: intrathecal morphine100 µg intrathecal morphine and saline infiltration |
| placebo | Placebo comparator | Drug: placebointrathecal saline and saline infiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.
Key exclusion criteria (7 listed)
- Refusal of the patient or contra-indication to locoregional anesthesia
- Allergy to the products used
- ASA 3
- ASA 4
- Sleep apnea syndrome and/or obesity (BMI > 35)
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 |
|---|---|---|
| ropivacaine infiltrationAlso: Naropin, local anestheticwound infiltration | Drug | ropivacaine infiltration |
| intrathecal morphineAlso: spinal morphine100 µg added to the spinal anaesthesia | Drug | rachi morphine |
| placeboAlso: Nacl 0,9 %, saline solutionplacebo in spinal anaesthesia and in wound infiltration | Drug | placebo |
Primary outcome
Duration of Effective Analgesia
Time frame: 30 hours after spinal injection T0
T0 until first request of morphine PCAIV
Morphine Consumption
Time frame: 30 hours after spinal injection T0
Morphine consumption with PCAIV
1 secondary outcome
Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.
Time frame: 30 hours after spinal injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post Caesarean Analgesia
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Butorphanol for Pain Relief After Cesarean Section: A Retrospective Study
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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.
Philippe Van der Linden, PhD, MD study director
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropivacaine infiltration and intrathecal morphine in people with Post Caesarean Analgesia, run by Dr Madeleine Wilwerth at 1 site in Belgium.
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 7 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 9 Jun 2015. 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 Belgium. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Effective Analgesia (time frame: 30 hours after spinal injection T0). The study lists 2 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 9 Jun 2015.