Intravenous Remifentanil for Labor Analgesia

Study Overview
=================
Brief Summary
-----------------
Labor analgesia is an essential health caring procedure for women. However, epidural analgesia cannot be performed on all subjects for different contraindications, such as lower platelet counter, back infection at the puncture site, and fear of epidural injection etc. Therefore, intravenous analgesia is an alternative for such conditions. Given the influence of intravenous administration of drugs on fetus, the drug selection is very important. Remifentanil, a super-short efficacious opioid, can last for 3-4 minutes after injection, which is similar in both maternal and fetal environment. Thus the fetus-associated side effects would be less than other drugs. The investigators hypothesized that remifentanil would be a superior intravenous drug used with patient-controlled technique for labor analgesia.

Official Title
-----------------
Remifentanil Intravenous Patient-controlled Labor Analgesia for Nulliparous Women

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: Hydromorphone
* Drug: Remifentanil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nulliparous women > 18 years and < 45 years Spontaneous labor Analgesia request Epidural puncture contraindications Tendency of bleeding Exclusion Criteria: Allergy to opioids, a history of the use of centrally-acting drugs of any sort, chronic pain and psychiatric diseases records Participants younger than 18 years or older than 45 years Those who were not willing to or could not finish the whole study at any time Using or used in the past 14 days of the monoamine oxidase inhibitors Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics Subjects with a nonvertex presentation or scheduled induction of labor Cervical dilation was 5.0cm or greater before performing epidural puncture and catheterization Diagnosed diabetes mellitus and pregnancy-induced hypertension Twin gestation and breech presentation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Intravenous administration of hydromorphone intermittently | Drug: Hydromorphone<br>* Intravenous administration of hydromorphone 1mg at the patient's request if they felt uterine contraction pain<br>|
| Experimental: 2<br>Remifentanil intravenous patient-controlled analgesia | Drug: Remifentanil<br>* Remifentanil intravenous PCA: 0.2μg/kg, lockout time interval 2 minutes, continuous infusion rate 0.2-0.8μg/kg/min.<br>* Other names: ReiFen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Visual Analog Scale (VAS) rating of pain |  | Prior to analgesia, latent phrase, active phrase, second stage of labor, posterior to vaginal delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cesarean delivery |  | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | 
| Rate of instrument-assisted delivery |  | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | 
| Indications of cesarean delivery |  | Analgesia initiation (0 min) to cesarean section (this time period underwent changing in different individuals) | 
| Duration of analgesia |  | Initiation of analgesia (0 min) to the disappearance of sensory block (this time period underwent changing in different individuals) | 
| Maternal satisfaction with analgesia |  | At the end of the vaginal delivery (this time period underwent changing in different individuals) | 
| Maternal oral temperature |  | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | 
| Use of oxytocin after analgesia |  | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | 
| Maximal oxytocin dose |  | At the end of vaginal delivery (this time period underwent changing in different individuals) | 
| Breastfeeding success at 6 weeks after vaginal delivery |  | At the sixth week after successful delivery | 
| Neonatal one-minute Apgar scale |  | At the first minute of baby was born | 
| Neonatal five-minute Apgar scale |  | At the fifth minute of baby was born | 
| Umbilical-cord gases analysis |  | At the time baby was born (0 min) | 
| Neonatal sepsis evaluation |  | After the baby was born (15 min after delivery) | 
| Neonatal antibiotic treatment |  | After the baby was born (one day after delivery) | 
| Incidence of maternal side effects |  | Analgesia initiation (0 min) to successful vaginal delivery (this time period underwent changing in different individuals) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remifentanil, Patient-controlled analgesia, Intravenous analgesia