Diclofenac vs. Ropivacaine for Cesarean Section

The Analgesic Efficacy of Continuous Wound Instillation With Diclofenac or Ropivacaine Following Cesarean Section: a Randomized, Double-blind, Placebo Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Ropivacaine, Diclofenac, Water for injection

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
• Enrollment (Anticipated): 75
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Kfar-Saba, Israel, 44281
    • Meir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients undergoing Cesarean section

Exclusion Criteria:

A history of clinically significant disease:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1)Pain intensity 2)"Rescue" analgesia requirements	24 hours

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: December 2, 2008
• First Submitted That Met QC Criteria: December 2, 2008
• First Posted (ESTIMATE): December 3, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): May 4, 2010
• Last Update Submitted That Met QC Criteria: May 2, 2010
• Last Verified: December 1, 2008

More Information

Terms related to this study

• Keywords: ropivacaine; diclofenac; local anesthetic instillation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Anesthetics, Local; Ropivacaine; Diclofenac
• Other Study ID Numbers: MMC-0202-07