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Diclofenac vs. Ropivacaine for Cesarean Section

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ClinicalTrials.gov Identifier: NCT00801528
Recruitment Status : Completed
First Posted : December 3, 2008
Last Update Posted : May 4, 2010
Sponsor:
Information provided by:
Meir Medical Center

Tracking Information
First Submitted Date  ICMJE December 2, 2008
First Posted Date  ICMJE December 3, 2008
Last Update Posted Date May 4, 2010
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2008)
1)Pain intensity 2)"Rescue" analgesia requirements [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00801528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diclofenac vs. Ropivacaine for Cesarean Section
Official Title  ICMJE The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study
Brief 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.
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:

  1. Demographic data
  2. Surgical milestones(Anesthetic time, surgical time etc).
  3. Incidence of failed intrathecal anesthesia
  4. VAS for pain every 15 min during first 6 postoperative hours
  5. Time to first pain (intrathecal anesthesia to VAS > 60 mm)
  6. Number of infusion events (10 mL and 5 mL)
  7. Rescue morphine administration during first 6 postoperative hours.
  8. Subcutaneous morphine administration during subsequent 18 postoperative hours.
  9. VAS for pain.
  10. The incidence of nausea and vomiting.
  11. Patient satisfaction at 24 hours, postoperatively.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cesarean Section
Intervention  ICMJE Drug: Ropivacaine, Diclofenac, Water for injection
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 Arms  ICMJE
  • Active Comparator: Ropivacaine
    Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr
    Intervention: Drug: Ropivacaine, Diclofenac, Water for injection
  • Active Comparator: Diclofenac
    Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr
    Intervention: Drug: Ropivacaine, Diclofenac, Water for injection
  • Placebo Comparator: Water for injection
    Continuous wound instillation of water for injection at a rate set of 10 mL/hr
    Intervention: Drug: Ropivacaine, Diclofenac, Water for injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 2, 2008)
75
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing Cesarean section

Exclusion Criteria:

A history of clinically significant disease:

  • cardiovascular
  • pulmonary
  • hepatic
  • renal
  • neurologic
  • psychiatric
  • metabolic disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00801528
Other Study ID Numbers  ICMJE MMC-0202-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alex Khaikin MD, Meir Medical Center
Study Sponsor  ICMJE Meir Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Meir Medical Center
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP