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

NCT00804609 | Completed Results

• 1 other identifier: SU-07022008-1228
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Epidural Analgesia, Obstetric

Outcome Measures

Primary Outcomes (1)

• Maximum Plasma Concentration (Cmax) of Extended Release Epidural Morphine (EREM)

  The primary end point was to evaluate the pharmacokinetic profiles of EREM after either no epidural lidocaine or after an epidural lidocaine top-up for cesarean delivery.

  a plasma sample at 0, 5, 10, 15, and 30 minutes, and 1, 4, 8, 12, 24, 36, 48, and 72 hours post-dose

Study Arms (2)

DepoDur following epidural lidocaine

ACTIVE COMPARATOR

Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.

Drug: DepoDur following epidural lidocaine

DepoDur following spinal anesthetic

ACTIVE COMPARATOR

Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.

Drug: DepoDur following spinal anesthetic

Interventions

DepoDur following epidural lidocaine DRUG

All participant underwent cesarean delivery. An epidural "top-up" anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered. Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration.

Also known as: DepoDur™, EREM (Extended Release Epidural Morphine)

DepoDur following epidural lidocaine

DepoDur following spinal anesthetic DRUG

Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space. Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug.

Also known as: DepoDur, EREM, extended release epidural morphine

DepoDur following spinal anesthetic

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Results Point of Contact

• Title: Brendan Carvalho
• Organization: Stanford University

bcarvalho@stanford.edu

650-861-8607

Study Officials

• Brendan Carvalho

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: December 9, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 12, 2017
• Results First Posted: March 7, 2016

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)