Postoperative PainPhase 4NCT02279628
Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section
A Phase 4 study testing Ropivacaine and Morphine in people with Postoperative Pain, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ropivacaine and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2014to Jun 2017
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective Cesarean section
- Spinal anesthesia
- Singleton
- ASA ( Physical status score) 1 to 3
Who cannot join
- Age <18yrs
- BMI ≥ 45 kg/m2 or weight < 45 kg
- Refusal to consent
- Urgent cesarean section
- Allergy to a medication used in the protocol
- Impaired hemostasis ou current infection
- Contra indication or failure of spinal anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Maternité Régionale Universitaire (MRU)
Nancy, Lorraine, 54000
Florence VIAL, MD, +33 3 83 34 44 67, f.vial@maternite.chu-nancy.fr
Hervé BOUAZIZ, MD., PhD., +33 3 83 34 44 67, h.bouaziz@chu-nancy.fr
About this study
Official title: Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.
Read the detailed description
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.
- Conditions
- Postoperative Pain
- Being tested
- Ropivacaine, Morphine
- Keywords
- cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)
MorphineDrug
Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period
| Study group | Role | What they receive |
|---|---|---|
| Continuous wound infiltration alone | Experimental | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. Receives: Drug: Ropivacaine |
| Intrathecal moprhine alone | Active comparator | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter. Receives: Drug: Morphine |
| Intrathecal morphine&wound infiltration | Experimental | Spinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. Receives: Drug: Ropivacaine; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption during the first 48 postoperative hours
Measured: at the 48th hour
Secondary outcomes (8)
Pain at rest and at mobilization
The pain at rest and at mobilization will be evaluated with both Visual Analog scale and Verbal pain scale. The patient should describe the worst pain felt during the previous 4 hours in a lying position and at mobilization
Measured: Every 4 hours during the first 48 postoperative hours
Time to restoration of bowel function
Measured: within the first 48 postoperative hours
Verbal and Visual analog pain scores in the first standing position
Measured: at day 1
Number of patients that required oral morphine
Measured: At the 24th and 48th hour
Number of patients that required local anesthetic rescue dose through the catheter
Measured: At the 24th and 48th hour
Postoperative rehabilitation survey
Measured: At the 48th hour
Occurrence of side effect
Itching, nausea and vomiting, drowsiness, urinary retention, hypoventilation, other will be assessed with a questionnaire
Measured: During the first 48 hours
Postoperative residual pain (DN4 survey)
Measured: At 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Maternite Regionale Universitaire
- Responsible party
- Sponsor
- Investigators
- Hervé BOUAZIZ, MD., PhD., Study chair, Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, FranceFlorence VIAL, MD., Principal investigator, Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, FrancePhilippe GUERCI, MD, Principal investigator, Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02279628
- Sponsor's protocol ID
- 2012-004498-14
- Status last verified
- Oct 2014
- First submitted
- 16 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.
PubMed 35274209
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Pre-uterine Wound Infiltration Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Section. Controlled Comparative Study.
- ClinicalTrials.gov ID
- NCT02279628
- Acronym / sponsor ID
- 2012-004498-14
- Conditions
- Postoperative Pain
- Keywords
- cesarean section, spinal anesthesia, continuous wound infiltration, intrathecal morphine, oral morphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Maternite Regionale Universitaire
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 31 Oct 2014 (estimated)
- 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.
The cesarean section is considered as a painful surgery during the post operative period. Mothers may need to move immediately after the surgery to take care of their babies. This may increase the risk of major pain and chronic pain. Thus, excellent postoperative analgesia is required so that mothers do not experience pain in caring for their baby. Currently, several techniques have been developed to manage postoperative pain related to c-section scar such as intrathecal morphine during spinal anesthesia or continuous pre-peritoneal wound infiltration. The comparison between anesthetic techniques has never been performed and it is still not know if the combination of intrathecal morphine plus continuous pre-peritoneal wound infiltration provide a synergistic or additional effect on pain relief.
Detailed description
The aim of this study is to compare the efficacy of continuous wound infiltration versus intrathecal morphine for postoperative analgesia after scheduled cesarean section. The primary endpoint is morphine consumption during the first 48 postoperative hours.
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 |
|---|---|---|
| Continuous wound infiltration alone | Experimental | Drug: RopivacaineSpinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 1 ml sodium chloride 0.9% (without morphine). Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. |
| Intrathecal moprhine alone | Active comparator | Drug: MorphineSpinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of sodium chloride 0.9% 8 ml/H via a preperitoneal catheter. |
| Intrathecal morphine&wound infiltration | Experimental | Drug: Ropivacaine, Drug: MorphineSpinal anesthesia will be performed with 10 mg bupivacain 0.5% hyperbaric, 3 μg sufentanil and 0.1mg morphine. Patient will then receive a continuous wound infiltration of ropivacaine 0.2% 8 ml/H via a preperitoneal catheter. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Elective Cesarean section
- Spinal anesthesia
- Singleton
- ASA ( Physical status score) 1 to 3
Key exclusion criteria (7 listed)
- Age <18yrs
- BMI ≥ 45 kg/m2 or weight < 45 kg
- Refusal to consent
- Urgent cesarean section
- Allergy to a medication used in the protocol
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 |
|---|---|---|
| RopivacaineRopivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H) | Drug | Continuous wound infiltration alone, Intrathecal morphine&wound infiltration |
| MorphineMorphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period | Drug | Intrathecal moprhine alone, Intrathecal morphine&wound infiltration |
Primary outcome
Morphine consumption during the first 48 postoperative hours
Time frame: at the 48th hour
8 secondary outcomes
Pain at rest and at mobilization
Time frame: Every 4 hours during the first 48 postoperative hours
Time to restoration of bowel function
Time frame: within the first 48 postoperative hours
Verbal and Visual analog pain scores in the first standing position
Time frame: at day 1
Number of patients that required oral morphine
Time frame: At the 24th and 48th hour
Number of patients that required local anesthetic rescue dose through the catheter
Time frame: At the 24th and 48th hour
Postoperative rehabilitation survey
Time frame: At the 48th hour
Occurrence of side effect
Time frame: During the first 48 hours
Postoperative residual pain (DN4 survey)
Time frame: At 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2014.
- Derived from this study: PubMed 35274209Viviand C, Pietretti E, Luc A, Herbain D, Baka N, Morel O, Feugeas J, Aron C, Bouaziz H, Guerci P, Vial F. Continuous wound infusion combined with intrathecal morphine for analgesia after Cesarean delivery compared with intrathecal morphine or continuous wound infusion alone. Can J Anaesth. 2022 Jun;69(6):788-789. doi: 10.1007/s12630-022-02223-2. Epub 2022 Mar 10.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Hervé BOUAZIZ, MD., PhD. study chair
Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Florence VIAL, MD. principal investigator
Department of Anesthesiology, Maternité Régionale Universitaire, CHU NANCY, France
Philippe GUERCI, MD principal investigator
Department of Anesthesiology and Critical Care Medicine, CHU NANCY Brabois, FRANCE
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 Ropivacaine and Morphine in people with Postoperative Pain, run by Central Hospital, Nancy, France 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 4 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: status not confirmed, as of the sponsor's last update on 31 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florence VIAL, MD (+ 33 3 83 34 43 67, f.vial@maternite.chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption during the first 48 postoperative hours (time frame: at the 48th hour). 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 NCT02279628, 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 31 Oct 2014.