Epidural Neostigmine for Labor Pain

Epidural Neostigmine Dose Response for the Treatment of Labor Pain

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Neostigmine; Drug: fentanyl

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bupivacaine with Neostimgine 8 mcg/ml; STUDY DRUG INFUSION WITH NEOSTIGMINE 8 MCG/ML	Drug: Bupivacaine; Drug: Neostigmine; utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
EXPERIMENTAL: Bupivacaine and Neostigmine 4 mcg/ml; STUDY DRUG INFUSION CONC NEOSTIGMINE 4 MCG/ML	Drug: Bupivacaine; Drug: Neostigmine; utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
EXPERIMENTAL: Bupivacaine with Neostigmine 2 mcg/ml; STUDY DRUG INFUSION NEOSTIGMINE 2 MCG/ML	Drug: Bupivacaine; Drug: Neostigmine; utilizing 3 different dosages of neostigmine and comparing it to the standard of fentanyl. Infusion runs via PCA throughout labor analgesia.
ACTIVE_COMPARATOR: BUPIVACAINE WITH FENTANYL 2 MCG/ML; Bupivacaine with fentanyl 2 mcg/ml. STANDARD INFUSION	Drug: Bupivacaine; Drug: fentanyl; fentanyl 2 mcg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Drug Consumed Per Hour in Each Group(Arm)	Median hourly total bupivacaine consumption. Drug amount consumed per hour of each group (arm)	until delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	average maximum nausea score in each group--maternal nausea scored on a 0-no nausea at all up to maximum of 10-worst nausea imaginable	until delivery
Sedation	average maternal sedation score measured on a 0-not sleepy at all up to a maximum of 10-extremely sleepy	until delivery
Shivering	maternal occurrence of shivering--Shivering scored on a 0-no shivering at all up to maximum of 10-shivering uncontrollably	until delivery
Pruritus	the occurrence of pruritis (itching) throughout the labor analgesia infusion--the presence of itching rated on a scale of 0-no itching at all up to a maximum of 10- severe itching.	until delivery
Bromage Score	the incidence of decreased motor block (Bromage score) documented until delivery. Bromage is defined as 0-freely able to move extremities (no motor block) up to 3-unable to move legs or feet (complete motor block)	until delivery
Patient Satisfaction Scores	maternal reported satisfaction scores of labor analgesia on a scale of 1-5, with 1-not satisfied at all up to 5 -completely satisfied with labor analgesia	within 24 hours post delivery
Cesarean Delivery	percentage of subjects in each group requiring a ceserean delivery	occurence

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Peter H Pan, MD, Wake Forest University Health Sciences OB Anesthesia

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 22, 2008
• First Posted (ESTIMATE): October 24, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 11, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: epidural; labor pain; non narcotic; Non narcotic treatment of labor pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Cholinesterase Inhibitors; Parasympathomimetics; Fentanyl; Bupivacaine; Neostigmine
• Other Study ID Numbers: IRB00005917

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No