Sole Local Anesthetic Versus Opioid Plus Local Anesthesia in Epidural Labor Analgesia (OLAA)

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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Sole local anesthetic; Drug: Sufentanil (Opioid plus local anesthetic)

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sole local anesthetic; Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently	Drug: Ropivacaine; Drug: Sole local anesthetic; 0.125% ropivacaine 10-15 ml every 1h during labor delivery; Other Names: Naropin; Ropivacaine
Active Comparator: Opioid plus local anesthetic; Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently	Drug: Ropivacaine; Drug: Sufentanil (Opioid plus local anesthetic); Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
Cesarean section	Record the incidence of Cesarean section after completion of the labor delivery.	The time at the end of the labor delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to latent phase	Record the time duration	From the beginning of regular contraction of uterus to the dilation of cervical 4cm
Time of active phase	Record the time duration	From the cervix 4cm to the dilation of cervical 10cm
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
Oxytocin usage	Record the total usage of oxytocin after completion of the labor delivery	At the time of the end of the labor
Neonatal Apgar score		At the time of the baby was born, 1min, 5min, 10min and 20min
Instrumental delivery	Record the incidence of instrumental delivery after completion of the labor delivery.	At the time of the end of the labor
Umbilical gas analysis		At the time of the fetus was delivery

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Publications and helpful links

General Publications

• Wang X, Xu S, Qin X, Li X, Feng SW, Liu Y, Wang W, Guo X, Shen R, Shen X, Wang F. Comparison Between the Use of Ropivacaine Alone and Ropivacaine With Sufentanil in Epidural Labor Analgesia. Medicine (Baltimore). 2015 Oct;94(43):e1882. doi: 10.1097/MD.0000000000001882.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 11, 2014
• First Submitted That Met QC Criteria: January 13, 2014
• First Posted (Estimate): January 14, 2014

Study Record Updates

• Last Update Posted (Estimate): February 4, 2014
• Last Update Submitted That Met QC Criteria: February 1, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Safety; Opioid; Local anesthetic; Labor delivery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics; Anesthetics, Local; Ropivacaine; Sufentanil
• Other Study ID Numbers: NJFY13007; JQX12009 (Other Grant/Funding Number: Nanjing Municipal Bureau of Health)