Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

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The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ropivacaine

Subjects will receive 440 mg ropivacaine and 30 mg ketorolac. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

Ketorolac

Intervention Type DRUG

Placebo

Subjects will receive saline placebo. Infusion of study medication will start after the skin is sutured and will continue for 48 hours after cesarean delivery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Ketorolac

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology (ASA) class 1,2, and 3
* English speaking women at a gestational age \> 37 weeks
* scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia

Exclusion Criteria

* BMI \> 50 kg/m2
* history of intravenous drug or opioid abuse
* previous history of chronic pain syndrome
* history of opioid use in the past week
* allergy or contraindication to any of the study medications
* non-English speaking

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No