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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 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 (PAINfusorâ„¢, 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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Active Comparator | Continuous wound instillation of ropivacaine 0.2 % at a rate set of 10 mL/hr |
|
| Diclofenac | Active Comparator | Continuous wound instillation of diclofenac (300 mg/240 ml water for injection) at a rate set of 10 mL/hr |
|
| Water for injection | Placebo Comparator | Continuous wound instillation of water for injection at a rate set of 10 mL/hr |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine, Diclofenac, Water for injection | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 1)Pain intensity 2)"Rescue" analgesia requirements | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
A history of clinically significant disease:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Kfar Saba | 44281 | Israel |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004008 | Diclofenac |
| D014867 | Water |
| D007267 | Injections |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| D000588 |
| Amines |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |