Diclofenac vs. Ropivacaine for Cesarean Section - Full Text View

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Ropivacaine monohydrochloride

U.S. FDA Resources

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
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

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

Locations

Israel
Meir Medical Center
Kfar-Saba, Israel, 44281

Sponsors and Collaborators

Meir Medical Center

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 May 24, 2012