Diclofenac vs. Ropivacaine for Cesarean Section

NCT ID: NCT00801528

Last Updated: 2010-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-12-31

Brief Summary

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.

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.

Conditions

Cesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ropivacaine

Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr

Group Type: ACTIVE_COMPARATOR

Ropivacaine, Diclofenac, Water for injection

Intervention Type: DRUG

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

Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr

Group Type: ACTIVE_COMPARATOR

Ropivacaine, Diclofenac, Water for injection

Intervention Type: DRUG

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

Continuous wound instillation of water for injection at a rate set of 10 mL/hr

Group Type: PLACEBO_COMPARATOR

Ropivacaine, Diclofenac, Water for injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing Cesarean section

Exclusion Criteria

A history of clinically significant disease:

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Meir Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Countries

Israel

Other Identifiers

MMC-0202-07

Identifier Type: -

Identifier Source: org_study_id