N/A Completed N=30 Randomized Quadruple-blind Treatment

Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery

Epidural Analgesia, Obstetric

Source: ClinicalTrials.gov NCT00804609 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Mar 2016

Primary outcomePrimary: Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM) — 11.1; 8.3 ng/mL

Summary

To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space.

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)	11.1; 8.3	—

Eligibility Criteria

Inclusion Criteria

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.

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Data sourced from ClinicalTrials.gov (NCT00804609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.