AnalgesiaPhase 4NCT04755712
Comparison of Two Analgesic Strategies After Scheduled Caesarean
A Phase 4 study testing Rachianesthesia, Sodium Chloride Injection and Morphine in people with Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Rachianesthesia, Sodium Chloride Injection and Morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2021to 12 Oct 2022
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
- Patient in good health ;
- Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
Who cannot join
- Pregnancy less than 37 weeks with amenorrhea;
- Multiple pregnancy;
- Fetal pathology known at the time of inclusion;
- Body mass index> 45 kg / m²;
- History of scoliosis or spine surgery;
- History of chronic pain associated with taking opiates, neuropathic pain, neurological pathology;
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- Preoperative anemia (blood hemoglobin <9 g / dL);
- Hypersensitivity to ropivacaine or other local anesthetics with amide bond;
- Hypersensitivity to morphine or opioids;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.
Read the detailed description
Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RachianesthesiaDrug
Also called Bupivacaine and sufentanil
Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
Sodium Chloride InjectionDrug
Also called sham-QLB2
Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2").
MorphineDrug
Also called injection of morphine
Morphine via pump (patient controlled analgesia)
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine in quadratum lumburum block 2 | Experimental | Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian. Receives: Drug: Rachianesthesia; Drug: Morphine |
| Intrathecal morphine | Active comparator | Morphine will be administrated in intrathecal Receives: Drug: Rachianesthesia; Drug: Sodium Chloride Injection; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative quantity of morphine received postoperatively via pump
The main objective of the study is to demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.
Measured: 1 day
Secondary outcomes (3)
Characteristics of postoperative pain using a visual analogic scale
Evaluate the characteristics of postoperative pain in both groups with the use of a visual analog scale
Measured: 2 days
Side effects of the two analgesic strategies
Evaluate the side effects of the two analgesic strategies reported in a case report form
Measured: 2 days
Cumulative quantity of morphine received postoperatively via pump
Demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start22 Mar 2021
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755712
- Sponsor's protocol ID
- 2020-A03334-35
- Status last verified
- Oct 2022
- First submitted
- 8 Feb 2021
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Giral T, Delvaux BV, Huynh D, Morel B, Zanoun N, Ehooman F, Garnier T, Maupain O. Posterior quadratus lumborum block versus intrathecal morphine analgesia after scheduled cesarean section: a prospective, randomized, controlled study. Reg Anesth Pain Med. 2026 Jan 5;51(1):82-89. doi: 10.1136/rapm-2024-105454.
PubMed 39237149
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
- ClinicalTrials.gov ID
- NCT04755712
- Acronym / sponsor ID
- 2020-A03334-35
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 16 Feb 2021 (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 demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.
Detailed description
Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropivacaine in quadratum lumburum block 2 | Experimental | Drug: Rachianesthesia, Drug: MorphineRopivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian. |
| Intrathecal morphine | Active comparator | Drug: Rachianesthesia, Drug: Sodium Chloride Injection, Drug: MorphineMorphine will be administrated in intrathecal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
- Patient in good health ;
- Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
Key exclusion criteria (9 listed)
- Pregnancy less than 37 weeks with amenorrhea;
- Multiple pregnancy;
- Fetal pathology known at the time of inclusion;
- Body mass index> 45 kg / m²;
- History of scoliosis or spine surgery;
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 |
|---|---|---|
| RachianesthesiaAlso: Bupivacaine and sufentanilAdministration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil) | Drug | Intrathecal morphine, ropivacaine in quadratum lumburum block 2 |
| Sodium Chloride InjectionAlso: sham-QLB2Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound ("sham-QLB2"). | Drug | Intrathecal morphine |
| MorphineAlso: injection of morphineMorphine via pump (patient controlled analgesia) | Drug | Intrathecal morphine, ropivacaine in quadratum lumburum block 2 |
Primary outcome
Cumulative quantity of morphine received postoperatively via pump
Time frame: 1 day
The main objective of the study is to demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.
3 secondary outcomes
Characteristics of postoperative pain using a visual analogic scale
Time frame: 2 days
Side effects of the two analgesic strategies
Time frame: 2 days
Cumulative quantity of morphine received postoperatively via pump
Time frame: 2 days
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 5 Aug 2024.
- Derived from this study: PubMed 39237149Giral T, Delvaux BV, Huynh D, Morel B, Zanoun N, Ehooman F, Garnier T, Maupain O. Posterior quadratus lumborum block versus intrathecal morphine analgesia after scheduled cesarean section: a prospective, randomized, controlled study. Reg Anesth Pain Med. 2026 Jan 5;51(1):82-89. doi: 10.1136/rapm-2024-105454.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rachianesthesia, Sodium Chloride Injection and Morphine in people with Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 3 inclusion and 9 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 5 Aug 2024. 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 France. 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?
Cumulative quantity of morphine received postoperatively via pump (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755712, which also lists 1 linked publication.
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 5 Aug 2024.