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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

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.

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Ropivacaine, Diclofenac, Water for injection Phase 4

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study
Study Start Date : April 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Ropivacaine
Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr
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.
Active Comparator: Diclofenac
Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr
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.
Placebo Comparator: Water for injection
Continuous wound instillation of water for injection at a rate set of 10 mL/hr
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.



Primary Outcome Measures :
  1. 1)Pain intensity 2)"Rescue" analgesia requirements [ Time Frame: 24 hours ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Cesarean section

Exclusion Criteria:

A history of clinically significant disease:

  • cardiovascular
  • pulmonary
  • hepatic
  • renal
  • neurologic
  • psychiatric
  • metabolic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801528


Locations
Israel
Meir Medical Center
Kfar-Saba, Israel, 44281
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Alex Khaikin MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT00801528     History of Changes
Other Study ID Numbers: MMC-0202-07
First Posted: December 3, 2008    Key Record Dates
Last Update Posted: May 4, 2010
Last Verified: December 2008

Keywords provided by Meir Medical Center:
ropivacaine
diclofenac
local anesthetic instillation

Additional relevant MeSH terms:
Ropivacaine
Diclofenac
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action