Epidural Neostigmine for Labor Pain
This study is currently recruiting participants.
Verified March 2013 by Wake Forest University
Sponsor:
Wake Forest University
Information provided by (Responsible Party):
Dr. Peter H. Pan, M.D., MSEE, Wake Forest University
ClinicalTrials.gov Identifier:
NCT00779467
First received: October 22, 2008
Last updated: March 5, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to see which dose of epidural neostigmine is the best additive to use with the numbing medication used in an epidural during labor.
| Condition | Intervention |
|---|---|
|
Labor Pain |
Drug: Neostigmine Drug: Bupivacaine Drug: fentanyl |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Epidural Neostigmine Dose Response for the Treatment of Labor Pain |
Resource links provided by NLM:
Drug Information available for:
Neostigmine methylsulfate
Fentanyl
Fentanyl citrate
Bupivacaine hydrochloride
Bupivacaine
U.S. FDA Resources
Further study details as provided by Wake Forest University:
Primary Outcome Measures:
- To identify non-narcotic agents and the best dose to use in treating labor pain. [ Time Frame: after initial epidural dosing, every; 2 hours until delivery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bupivacaine with Neostimgine 8 mcg/ml
STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML
|
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
|
|
Experimental: Bupivacaine and Neostigmine 4 mcg/ml
STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML
|
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
|
|
Experimental: Bupivacaine with Neostigmine 2 mcg/ml
STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML
|
Drug: Neostigmine
utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
Drug: Bupivacaine
|
|
Active Comparator: BUPIVACAINE WITH FENTANYL 2 MCG/ML
Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION
|
Drug: Bupivacaine
Drug: fentanyl
fentanyl 2 mcg/ml
|
Detailed Description:
This study is examining the use of the non-narcotic medication, neostigmine, in combination with the local anesthetic bupivacaine when compared with the commonly used narcotic fentanyl in providing pain relief with the fewest side effects in labor analgesia.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Healthy pregnancy
- Term pregnancy ( > 37 weeks)
- Primiparous or multiparous
- Induction or spontaneous labor greater or = 18 years of age
- Cervical exam on entry </=5 cm
Exclusion Criteria:
- Weight > 115 kg
- Non-English speaking
- IV analgesics within 60 minutes prior to epidural being administered
- Allergy to local anesthetics or neostigmine
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779467
Contacts
| Contact: Lynne Harris, BSN | 336-718-6049 | lcharris@wakehealth.edu |
Locations
| United States, North Carolina | |
| Forsyth Medical Center | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Lynne Harris, BSN 336-718-6049 | |
| Principal Investigator: Peter H Pan, MD | |
| Sub-Investigator: James Eisenach, MD | |
| Sub-Investigator: Robert D'Angelo, MD | |
| Sub-Investigator: Ashley Tonidandel, MD | |
| Sub-Investigator: Vernon Ross, MD | |
| Sub-Investigator: John Thomas, MD | |
| Sub-Investigator: Nichole Taylor, MD | |
| Sub-Investigator: David Hood, MD | |
| Sub-Investigator: Terrence Bogard, MD | |
| Sub-Investigator: Medge Owen, MD | |
| Sub-Investigator: Kenneth Nelson, MD | |
Sponsors and Collaborators
Wake Forest University
Investigators
| Principal Investigator: | Peter H Pan, MD | Wake Forest University Health Sciences OB Anesthesia |
More Information
No publications provided
| Responsible Party: | Dr. Peter H. Pan, M.D., MSEE, Anesthesiologist, Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00779467 History of Changes |
| Other Study ID Numbers: | IRB5917 |
| Study First Received: | October 22, 2008 |
| Last Updated: | March 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Wake Forest University:
|
non narcotic epidural labor pain Non narcotic treatment of labor pain |
Additional relevant MeSH terms:
|
Labor Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Bupivacaine Fentanyl Neostigmine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents |
Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia Narcotics Analgesics Anesthetics, Intravenous Anesthetics, General Analgesics, Opioid Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Parasympathomimetics Autonomic Agents |
ClinicalTrials.gov processed this record on May 21, 2013