Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia

Pain Clinical Trial

— OLAA  

Official title:

Sole Epidural Local Anesthetic Versus Opioid Plus Local Anesthetic in Epidural Labor Pain Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02036242
• Other study ID #: NJFY13007
• Secondary ID: JQX12009
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2014
• Last updated: February 1, 2014
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

It is common for obstetric anesthesia using opioid supplement to local anesthetics for epidural labor pain control. Given the low doses of these epidural drugs, we never doubt the necessity of the supplement of opioid to lacal anesthetics during this process based on the concept that opioid addition can enhance and prolong the analgesic effect of local anesthetics. However, we unavoidably encounter many opioid-associated side effects during the labor delivery. In addition, usage of opioid increase the medical cost for each patient. We herein hypothesized that in the context of obstetric anesthesia, sole local anesthetics can produce as the same analgsic effect as opioid plus local anesthetics given for epidural labor pain control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparas

• Request epidural analgesia

• Chinese

Exclusion Criteria:

• Allergic to opioid or local anesthetics

• Fail to perform epidural puncture and catheterization

• Organ dysfunction

• Contraindications for epidural anesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Sole local anesthetic
0.125% ropivacaine 10-15 ml every 1h during labor delivery
• Sufentanil (Opioid plus local anesthetic)
Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
• Ropivacaine

Locations

Country	Name	City	State
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to latent phase	Record the time duration	From the beginning of regular contraction of uterus to the dilation of cervical 4cm	Yes
Other	Time of active phase	Record the time duration	From the cervix 4cm to the dilation of cervical 10cm	Yes
Other	Overall satisfaction of analgesia	Assess the analgesia satisfaction after the completion of the labor delivery	At the time of the end of the labor delivery	Yes
Other	Oxytocin usage	Record the total usage of oxytocin after completion of the labor delivery	At the time of the end of the labor	Yes
Other	Neonatal Apgar score		At the time of the baby was born, 1min, 5min, 10min and 20min	Yes
Other	Instrumental delivery	Record the incidence of instrumental delivery after completion of the labor delivery.	At the time of the end of the labor	Yes
Other	Umbilical gas analysis		At the time of the fetus was delivery	Yes
Primary	Pain scorings	Using visual analog scale (VAS) assess the pain intensity at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h for VAS pain 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	up to 3 days	Yes
Secondary	Pruritus	Record incidence of pruritus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Dizziness	Record incidence of dizziness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Nausea	Record incidence of nausea at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Vomiting	Record incidence of vomiting at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Drowsiness	Record incidence of drowsiness at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Sedation	Record incidence of sedation at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Respiratory depression	Record incidence of respiratory depression at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Psychological effects	Record incidence of psychological effects [euphoria, hallucinations, delirium and confusion] at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Myoclonus	This describes muscle rigidity and abnormal movement of the limbs and muscles.; Record incidence of myoclonus at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Maternal heart rate	Record incidence of maternal heart rate at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Miosis	Record incidence of miosis at the following time points: (1) immediate after randomization; (2) prior to epidural analgesia; (3) 0, 5, 10, 30, 60 min after epidural analgesia; (4) every 1 h 60 min later after epidural analgesia; (5) at cervical dilation reach to 4 cm and 10 cm; (6) when pushing starts; (7) after completion of labor; (8) post-delivery days 1, 2 and 3.	From post-randomization to post-delivery day 3	Yes
Secondary	Cesarean section	Record the incidence of Cesarean section after completion of the labor delivery.	The time at the end of the labor delivery	Yes