Cesarean SectionPhase 4NCT00801528
Diclofenac vs. Ropivacaine for Cesarean Section
A Phase 4 study testing Ropivacaine, Diclofenac, Water for injection in people with Cesarean Section, run by Meir Medical Center at 1 site in Israel.
Trial summary
A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Ropivacaine, Diclofenac, Water for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2008to Dec 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing Cesarean section
Who cannot join
- A history of clinically significant disease:
- cardiovascular
- pulmonary
- hepatic
- renal
- neurologic
- psychiatric
- metabolic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study
A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.
Read the detailed description
Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound infusion.
Design: Prospective, randomized, double-blind, placebo-controlled study. Setting: Large referral hospital. Patients: 75 women recovering from Cesarean section performed via a Pfannenstiel incision.
Interventions: On completion of the surgical procedure, a 15 cm 19G infusion catheter (PAINfusor™, Baxter) will be placed below the fascia. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).
- In Group Control water for injection will be administered.
- In Group Ropivacaine 0.2 % ropivacaine will be administered.
- In Group Diclofenac diclofenac (300 mg/240 ml of water for injection) will be administered.
During the first 6 postoperative hours, a co-investigator will administer "rescue" analgesia (10 ml bolus of infusion drug or rescue morphine). Thereafter, the catheter will be connected to an elastometric pump (LV 10 Infusor, Baxter) filled with either water for injection, ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection). The fluid will be administered as a constant infusion rate (10 mL/hr). Continuous wound infusion will be continued for the subsequent 18 postoperative hours. During this 18 hour period, subcutaneous morphine 4 mg will be administered on patient request for additional analgesia.
Measurements and Main Results: The following parameters will be assessed and recorded:
- Demographic data
- Surgical milestones(Anesthetic time, surgical time etc).
- Incidence of failed intrathecal anesthesia
- VAS for pain every 15 min during first 6 postoperative hours
- Time to first pain (intrathecal anesthesia to VAS > 60 mm)
- Number of infusion events (10 mL and 5 mL)
- Rescue morphine administration during first 6 postoperative hours.
- Subcutaneous morphine administration during subsequent 18 postoperative hours.
- VAS for pain.
- The incidence of nausea and vomiting.
- Patient satisfaction at 24 hours, postoperatively.
- Conditions
- Cesarean Section
- Being tested
- Ropivacaine, Diclofenac, Water for injection
- Keywords
- ropivacaine, diclofenac, local anesthetic instillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine, Diclofenac, Water for injectionDrug
Ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection) or water for injection will be administered as a constant instillation rate set of 10 mL/hr for the subsequent 18 postoperative hours.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | Active comparator | Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr Receives: Drug: Ropivacaine, Diclofenac, Water for injection |
| Diclofenac | Active comparator | Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr Receives: Drug: Ropivacaine, Diclofenac, Water for injection |
| Water for injection | Placebo comparator | Continuous wound instillation of water for injection at a rate set of 10 mL/hr Receives: Drug: Ropivacaine, Diclofenac, Water for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
1)Pain intensity 2)"Rescue" analgesia requirements
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801528
- Sponsor's protocol ID
- MMC-0202-07
- Status last verified
- Dec 2008
- First submitted
- 2 Dec 2008
- Last updated
- 4 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT00801528
- Acronym / sponsor ID
- MMC-0202-07
- Conditions
- Cesarean Section
- Keywords
- ropivacaine, diclofenac, local anesthetic instillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Dec 2008 (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.
A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound infusion using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.
Detailed description
Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound infusion.
Design: Prospective, randomized, double-blind, placebo-controlled study. Setting: Large referral hospital. Patients: 75 women recovering from Cesarean section performed via a Pfannenstiel incision.
Interventions: On completion of the surgical procedure, a 15 cm 19G infusion catheter (PAINfusor™, Baxter) will be placed below the fascia. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).
- In Group Control water for injection will be administered.
- In Group Ropivacaine 0.2 % ropivacaine will be administered.
- In Group Diclofenac diclofenac (300 mg/240 ml of water for injection) will be administered.
During the first 6 postoperative hours, a co-investigator will administer "rescue" analgesia (10 ml bolus of infusion drug or rescue morphine). Thereafter, the catheter will be connected to an elastometric pump (LV 10 Infusor, Baxter) filled with either water for injection, ropivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection). The fluid will be administered as a constant infusion rate (10 mL/hr). Continuous wound infusion will be continued for the subsequent 18 postoperative hours. During this 18 hour period, subcutaneous morphine 4 mg will be administered on patient request for additional analgesia.
Measurements and Main Results: The following parameters will be assessed and recorded:
- Demographic data
- Surgical milestones(Anesthetic time, surgical time etc).
- Incidence of failed intrathecal anesthesia
- VAS for pain every 15 min during first 6 postoperative hours
- Time to first pain (intrathecal anesthesia to VAS > 60 mm)
- Number of infusion events (10 mL and 5 mL)
- Rescue morphine administration during first 6 postoperative hours.
- Subcutaneous morphine administration during subsequent 18 postoperative hours.
- VAS for pain.
- The incidence of nausea and vomiting.
- Patient satisfaction at 24 hours, postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: Ropivacaine, Diclofenac, Water for injectionContinuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr |
| Diclofenac | Active comparator | Drug: Ropivacaine, Diclofenac, Water for injectionContinuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr |
| Water for injection | Placebo comparator | Drug: Ropivacaine, Diclofenac, Water for injectionContinuous wound instillation of water for injection at a rate set of 10 mL/hr |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing Cesarean section
Key exclusion criteria (8 listed)
- cardiovascular
- pulmonary
- hepatic
- renal
- neurologic
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, Diclofenac, Water for injectionRopivacaine 0.2 %, or diclofenac (300 mg/240 ml water for injection) or water for injection will be administered as a constant instillation rate set of 10 mL/hr for the subsequent 18 postoperative hours. | Drug | Diclofenac, Ropivacaine, Water for injection |
Primary outcome
1)Pain intensity 2)"Rescue" analgesia requirements
Time frame: 24 hours
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 4 May 2010.
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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 Ropivacaine, Diclofenac, Water for injection in people with Cesarean Section, run by Meir Medical Center at 1 site in Israel.
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 8 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 4 May 2010. 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 Israel. 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 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?
1)Pain intensity 2)"Rescue" analgesia requirements (time frame: 24 hours). 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 4 May 2010.