Cesarean SectionPhase 4Cesar-DolNCT01151943
Comparison of Two Types of Pain Relief After Cesarean Delivery
A Phase 4 study testing Transversus Abdominis Plane (TAP) Block and Incisional Infiltration of Local Anesthetic in people with Cesarean Section, run by Hopital Foch at 1 site in France.
Trial summary
Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Transversus Abdominis Plane (TAP) Block and Incisional Infiltration of Local Anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2010to Jul 2012
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- scheduled cesarean section performed under spinal anesthesia
- ASA I or II
- height above 1,55 m
- singleton pregnancy
Who cannot join
- contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.
- Conditions
- Cesarean Section
- Being tested
- Transversus Abdominis Plane (TAP) Block, Incisional Infiltration of Local Anesthetic
- Keywords
- cesarean section, continuous wound infiltration, transversus abdominis plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane (TAP) BlockOther
Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
Incisional Infiltration of Local AnestheticOther
continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Experimental | Patients will receive a bilateral transversus abdominis plane block Receives: Other: Transversus Abdominis Plane (TAP) Block |
| Incisional Infiltration of Local Anesthetic | Active comparator | Patients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours) Receives: Other: Incisional Infiltration of Local Anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of postoperative pain
Measured: 48 postoperative hours
Secondary outcomes (6)
delay before the first rescue dose of morphine
Measured: 48 postoperative hours
morphine requirement
Measured: 48 postoperative hours
complication of each loco-regional technique
Measured: end of hospitalisation
patient's satisfaction
Measured: end of hospitalisation
length of hospital stay
Measured: end of hospitalisation
occurrence of a neuropathic postoperative pain
Measured: 1 month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.
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 Cesarean SectionStudies 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Fischler, MD, Study chair, Hôpital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151943
- Sponsor's protocol ID
- 2010/15
- Other IDs
- 2010-019662-88
- Acronym
- Cesar-Dol
- Status last verified
- Nov 2016
- First submitted
- 24 Jun 2010
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.
PubMed 25093663
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Methods of Pain Relief After Cesarean Delivery: Transversus Abdominis Plane (TAP) Block Versus Incisional Infiltration With Local Anesthetic
- ClinicalTrials.gov ID
- NCT01151943
- Acronym / sponsor ID
- Cesar-Dol / 2010/15
- Conditions
- Cesarean Section
- Keywords
- cesarean section, continuous wound infiltration, transversus abdominis plane block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Jun 2010 (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.
Women undergoing elective cesarean delivery, performed under a standard spinal anesthesia, will be randomized to undergo either TAP block or incisional infiltration with local anesthetic, in addition to standard postoperative analgesia comprising regular acetaminophen, nefopam and ketoprofen. Short acting oral morphine will be given as a rescue treatment in case of severe pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane (TAP) Block | Experimental | Other: Transversus Abdominis Plane (TAP) BlockPatients will receive a bilateral transversus abdominis plane block |
| Incisional Infiltration of Local Anesthetic | Active comparator | Other: Incisional Infiltration of Local AnestheticPatients will receive an incisional infiltration with local anesthetic (continuous administration of levobupivacaïne during 48 hours) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- scheduled cesarean section performed under spinal anesthesia
- ASA I or II
- height above 1,55 m
- singleton pregnancy
Key exclusion criteria (1 listed)
- contre indication to a drug used in the study (levobupivacaine, ketoprofen, nefopam)
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 |
|---|---|---|
| Transversus Abdominis Plane (TAP) BlockBilateral injection of levobupivacaine (20 mL, 3.75 mg/mL) | Other | Transversus Abdominis Plane (TAP) Block |
| Incisional Infiltration of Local Anestheticcontinuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours. | Other | Incisional Infiltration of Local Anesthetic |
Primary outcome
severity of postoperative pain
Time frame: 48 postoperative hours
6 secondary outcomes
delay before the first rescue dose of morphine
Time frame: 48 postoperative hours
morphine requirement
Time frame: 48 postoperative hours
complication of each loco-regional technique
Time frame: end of hospitalisation
patient's satisfaction
Time frame: end of hospitalisation
length of hospital stay
Time frame: end of hospitalisation
occurrence of a neuropathic postoperative pain
Time frame: 1 month postoperatively
Results and safety
The study was stopped early (reason given: The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Derived from this study: PubMed 25093663Chandon M, Bonnet A, Burg Y, Barnichon C, DesMesnards-Smaja V, Sitbon B, Foiret C, Dreyfus JF, Rahmani J, Laloe PA, Fischler M, Le Guen M. Ultrasound-guided Transversus Abdominis plane block versus continuous wound infusion for post-caesarean analgesia: a randomized trial. PLoS One. 2014 Aug 5;9(8):e103971. doi: 10.1371/journal.pone.0103971. eCollection 2014.
Related trials for Cesarean Section
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
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.
Marc Fischler, MD study chair
Hôpital Foch
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 Transversus Abdominis Plane (TAP) Block and Incisional Infiltration of Local Anesthetic in people with Cesarean Section, run by Hopital Foch 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 1 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: stopped early, as of the sponsor's last update on 3 Nov 2016. 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 was stopped early (reason given: The study has been halted prematurely beacuse of the occurence of convulsions in one case after TAP block.). Results are not available in the source record.
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?
severity of postoperative pain (time frame: 48 postoperative hours). 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 NCT01151943, 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 3 Nov 2016.