Diclofenac vs. Ropivacaine for Cesarean Section

Phase 4

Completed

• Conditions: Cesarean Section
• Interventions: Drug: Ropivacaine, Diclofenac, Water for injection

• Registration Number: NCT00801528
• Lead Sponsor: Meir Medical Center

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.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2008-12
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Last Update Submitted: 2010-05-02
• Last Update Posted: 2010-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

• Patients undergoing Cesarean section

Exclusion Criteria

A history of clinically significant disease:

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine, Diclofenac, Water for injection	Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr
Diclofenac	Ropivacaine, Diclofenac, Water for injection	Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr
Water for injection	Ropivacaine, Diclofenac, Water for injection	Continuous wound instillation of water for injection at a rate set of 10 mL/hr

Primary Outcome Measures

Name	Time	Method
1)Pain intensity 2)"Rescue" analgesia requirements	24 hours

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Saba, Israel