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| 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 |
| 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.
|
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).
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:
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
A history of clinically significant disease:
Contacts and Locations| Contact: Alex Khaikin, MD | 972577482703 | Alexander_kh2005@yahoo.com |
| Contact: Edna Zohar, MD | 97297471545 | zohar.edna@clalit.org.il |
| Israel | |
| Meir Medical Center | Recruiting |
| Kfar-Saba, Israel, 44281 | |
More Information
| 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 |
|
ropivacaine diclofenac local anesthetic instillation |
|
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 |