Postoperative PainPhase 4KTcesarNCT01751256
Additional Effect of Wound Infiltration After Cesarean Section With Optimal Standard Analgesia
A Phase 4 study testing Continuous wound infiltration in people with Postoperative Pain and Anesthesia, Local, run by Poissy-Saint Germain Hospital at 1 site in France.
Trial summary
The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Pain, Anesthesia, Local, Breast Feeding
- What is being tested?
- Continuous wound infiltration
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Dec 2011
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled cesarean section
Who cannot join
- Emergency cesarean section
- Contraindication to opioids, paracetamol, or local anaesthetic
- Ongoing infection
- Coagulation disorders
- Diabetes treated with insulin
- Chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia
Read the detailed description
Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used.
Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.
Patients scheduled for caesarean delivery will be eligible for the study.
Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study.
One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump.
Total morphine consumption, pain and any associated complications will be recorded for 72 hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean section, assessing recovery, satisfaction and breastfeeding comfort.
- Conditions
- Postoperative Pain, Anesthesia, Local, Breast Feeding
- Being tested
- Continuous wound infiltration
- Keywords
- Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine
- Medical subject headings
- Pain, Postoperative, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous wound infiltrationDevice
Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).
| Study group | Role | What they receive |
|---|---|---|
| Continuous wound infiltration | Experimental | Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). Receives: Device: Continuous wound infiltration |
| Control | No intervention | Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Quantity of morphine injected by the patient controlled analgesia pump
Measured: 24 first hours after cesarean section
Secondary outcomes (13)
Pain at mobilization
Numerical pain scale during mobilization
Measured: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Early walking
Time taken for early walking
Measured: in the 72 first hours after skin closure
Resumption of gastrointestinal function
Interval from the end of surgery until the first gas from the intestinal tract
Measured: First 72 hours after skin closure
Treatment tolerance
Nausea, vomiting, pruritus, excessive sedation
Measured: First 72 hours after skin closure
Maternal satisfaction
Analogic numerical scale on a specific form
Measured: 2 days after skin closure
Health staff workload
Number of intervention for nursing, breastfeeding help, and cesarean wound dressing change
Measured: For the 48 first hours after skin closure
Wound infections
Number of wound infection needing specific cares appeared during the observation time
Measured: the first 10 days after skin closure
Local anaesthetic systemic toxicity
Every adverse effect attributed to local anaesthetic by an skilled anesthesiologist
Measured: During the first 48 hours after skin closure
Discomfort due to material
Discomfort caused by the material and pain at retrieval of the catheter, assessed by an analogic scale on a specific form
Measured: At catheter retrieval
Technical problems related to the catheter
Premature withdrawal or occlusion of the catheter
Measured: During the 48 first hours after skin closure
Pain at rest
Numerical pain scale at rest
Measured: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Comfort with Breast Feeding
Analogic numerical scale on a specific form
Measured: For the the 48 first hours after skin closure
All cause morbidity
Postpartum hemorrhage or every adverse event occurred during the observation period.
Measured: For the first 10 days after skin closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poissy-Saint Germain Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claude JOLLY, Poissy-Saint Germain Hospital
- Investigators
- Claude JOLLY, MD, Principal investigator, Poissy-Saint Germain Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751256
- Sponsor's protocol ID
- PoissyStGermainH
- Acronym
- KTcesar
- Status last verified
- Dec 2012
- First submitted
- 13 Dec 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
- ClinicalTrials.gov ID
- NCT01751256
- Acronym / sponsor ID
- KTcesar / PoissyStGermainH
- Conditions
- Postoperative Pain, Anesthesia, Local, Breast Feeding
- Keywords
- Postcesarean Section, Postoperative Pain, Care, Postoperative, Anesthesia, Local, Breast Feeding, Morphine, Pain Measurement, levobupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Poissy-Saint Germain HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Dec 2012 (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 purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia
Detailed description
Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used.
Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.
Patients scheduled for caesarean delivery will be eligible for the study.
Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study.
One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump.
Total morphine consumption, pain and any associated complications will be recorded for 72 hours. Women wil be asked to fulfill a questionnaire on the second day after cesarean section, assessing recovery, satisfaction and breastfeeding comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous wound infiltration | Experimental | Device: Continuous wound infiltrationSubfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). |
| Control | No intervention | –Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Scheduled cesarean section
Key exclusion criteria (6 listed)
- Emergency cesarean section
- Contraindication to opioids, paracetamol, or local anaesthetic
- Ongoing infection
- Coagulation disorders
- Diabetes treated with insulin
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 |
|---|---|---|
| Continuous wound infiltrationSubfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period). | Device | Continuous wound infiltration |
Primary outcome
Postoperative morphine consumption
Time frame: 24 first hours after cesarean section
Quantity of morphine injected by the patient controlled analgesia pump
13 secondary outcomes
Pain at mobilization
Time frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Early walking
Time frame: in the 72 first hours after skin closure
Resumption of gastrointestinal function
Time frame: First 72 hours after skin closure
Treatment tolerance
Time frame: First 72 hours after skin closure
Maternal satisfaction
Time frame: 2 days after skin closure
Health staff workload
Time frame: For the 48 first hours after skin closure
Wound infections
Time frame: the first 10 days after skin closure
Local anaesthetic systemic toxicity
Time frame: During the first 48 hours after skin closure
Discomfort due to material
Time frame: At catheter retrieval
Technical problems related to the catheter
Time frame: During the 48 first hours after skin closure
Pain at rest
Time frame: 4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room
Comfort with Breast Feeding
Time frame: For the the 48 first hours after skin closure
All cause morbidity
Time frame: For the first 10 days after skin closure
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 17 Dec 2012.
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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.
Claude JOLLY, MD principal investigator
Poissy-Saint Germain Hospital
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 Continuous wound infiltration in people with Postoperative Pain and Anesthesia, Local, run by Poissy-Saint Germain Hospital 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 1 inclusion and 6 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 17 Dec 2012. 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?
Postoperative morphine consumption (time frame: 24 first hours after cesarean section). 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 17 Dec 2012.