Diclofenac vs. Ropivacaine for Cesarean Section
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cesarean Section |
Drug: Ropivacaine, Diclofenac, Water for injection |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
- 1)Pain intensity 2)"Rescue" analgesia requirements [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| Responsible Party: | Alex Khaikin MD, Meir Medical Center |
| ClinicalTrials.gov Identifier: | NCT00801528 History of Changes |
| Other Study ID Numbers: | MMC-0202-07 |
| Study First Received: | December 2, 2008 |
| Last Updated: | May 2, 2010 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Meir Medical Center:
|
ropivacaine diclofenac local anesthetic instillation |
Additional relevant MeSH terms:
|
Diclofenac Ropivacaine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents |
Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Anesthetics, Local Anesthetics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on June 18, 2013