Diclofenac vs. Ropivacaine for Cesarean Section

Condition(s) targeted: Cesarean Section

Intervention: Ropivacaine, Diclofenac, Water for injection (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Meir Medical Center

Overall contact:
Alex Khaikin, MD, Phone: 972577482703, Email: Alexander_kh2005@yahoo.com

A prospective, randomized, double blind study designed to investigate analgesic efficacy of wound instillation using diclofenac or ropivacaine following Cesarean section performed via a Pfannenstiel incision.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: 1)Pain intensity 2)"Rescue" analgesia requirements

Detailed description: Study Objective: To assess the analgesic efficacy of diclofenac or ropivacaine when administered via wound instillation.

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 instillation catheter (PAINfusor™, Baxter) will be placed below the fascia. Postoperatively, the catheter will be attached to a patient controlled analgesia (PCA) device programmed to deliver 9 mL with a 60 min lockout time and no basal infusion. According to a computer generated randomization schedule, patients will be divided into one of three treatment groups (n = 25).

- In Group Control a bolus dose of 10 mL of water for injection will be

administered.

- In Group Ropivacaine a bolus dose of 10 mL 0. 2 % ropivacaine will be administered.

- In Group Diclofenac a bolus dose of 10 mL 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. 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 instillation at a rate set of 10 mL/hr. Continuous wound instillation 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, readiness for PACU discharge 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. Time to instillation onset (instillation to 50 % decrease in VAS for pain)

7. Number of instillations performed (10 mL and 5 mL)

8. Incidence of failed instillation (rescue morphine administration during first postoperative hours)

9. Subcutaneous morphine

10. VAS for pain at rest, on coughing and following leg raise on PACU admission, and at 6,12,18 and 24 hours postoperatively. The incidence of nausea and vomiting as well as uterine contractions will be assessed (yes/no) at these time intervals.

11. Patient satisfaction at 24 hours, postoperatively.

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Patients undergoing Cesarean section

Exclusion Criteria:

A history of clinically significant disease:

- cardiovascular

- pulmonary

- hepatic

- renal

- neurologic

- psychiatric

- metabolic disease

Alex Khaikin, MD, Phone: 972577482703, Email: Alexander_kh2005@yahoo.com

Meir Medical Center, Kfar-Saba 44281, Israel; Recruiting

Starting date: April 2008
Ending date: December 2008
Last updated: December 2, 2008