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Diclofenac vs. Ropivacaine for Cesarean Section
This study is currently recruiting participants.
Verified by Meir Medical Center, December 2008
First Received: December 2, 2008   No Changes Posted
Sponsor: Meir Medical Center
Information provided by: Meir Medical Center
ClinicalTrials.gov Identifier: NCT00801528
  Purpose

A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound instillation using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.


Condition Intervention Phase
Cesarean Section
Drug: Ropivacaine, Diclofenac, Water for injection
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-Blind, Placebo Controlled Study

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • 1)Pain intensity 2)"Rescue" analgesia requirements [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: April 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ropivacaine: Active Comparator
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.
Diclofenac: Active Comparator
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.
Water for injection: Placebo Comparator
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.

Detailed Description:

Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound instillation.

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 instillation catheter (PAINfusor™, Baxter) will be placed below the fascia. Postoperatively, the catheter will be attached to a patient controlled analgesia (PCA) device programmed to deliver 9 mL with a 60 min lockout time and no basal infusion. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).

  • In Group Control a bolus dose of 10 mL of water for injection will be administered.
  • In Group Ropivacaine a bolus dose of 10 mL 0.2 % ropivacaine will be administered.
  • In Group Diclofenac a bolus dose of 10 mL 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. 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 instillation at a rate set of 10 mL/hr. Continuous wound instillation 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, readiness for PACU discharge 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. Time to instillation onset (instillation to 50 % decrease in VAS for pain)
  7. Number of instillations performed (10 mL and 5 mL)
  8. Incidence of failed instillation (rescue morphine administration during first postoperative hours)
  9. Subcutaneous morphine
  10. VAS for pain at rest, on coughing and following leg raise on PACU admission, and at 6,12,18 and 24 hours postoperatively. The incidence of nausea and vomiting as well as uterine contractions will be assessed (yes/no) at these time intervals.
  11. Patient satisfaction at 24 hours, postoperatively.
  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801528

Contacts
Contact: Alex Khaikin, MD 972577482703 Alexander_kh2005@yahoo.com
Contact: Edna Zohar, MD 97297471545 zohar.edna@clalit.org.il

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

No publications provided

Responsible Party: Meir Medical Center ( Alex Khaikin MD )
Study ID Numbers: MMC-0202-07
Study First Received: December 2, 2008
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00801528     History of Changes
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on February 08, 2010