NCT02036242

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_4 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 4, 2014

Status Verified

February 1, 2014

Enrollment Period

5 months

First QC Date

January 11, 2014

Last Update Submit

February 1, 2014

Conditions

Pain

Keywords

OpioidLocal anestheticLabor deliverySafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Pruritus

    From post-randomization to post-delivery day 3

  • Dizziness

    From post-randomization to post-delivery day 3

  • Nausea

    From post-randomization to post-delivery day 3

  • Vomiting

    From post-randomization to post-delivery day 3

  • Drowsiness

    From post-randomization to post-delivery day 3

  • +7 more secondary outcomes

Other Outcomes (7)

  • Time to latent phase

    From the beginning of regular contraction of uterus to the dilation of cervical 4cm

  • Time of active phase

    From the cervix 4cm to the dilation of cervical 10cm

  • Overall satisfaction of analgesia

    At the time of the end of the labor delivery

  • +4 more other outcomes

Study Arms (2)

Sole local anesthetic

EXPERIMENTAL

Epidural analgesia will be given with sole local anesthetic (0.125% ropivacaine) intermittently

Drug: Sole local anestheticDrug: Ropivacaine

Opioid plus local anesthetic

ACTIVE COMPARATOR

Epidural analgesia will be given with opioid (sufentanil) combined with local anesthetic (0.125% ropivacaine) intermittently

Drug: Sufentanil (Opioid plus local anesthetic)Drug: Ropivacaine

Interventions

Sole local anestheticDRUG

0.125% ropivacaine 10-15 ml every 1h during labor delivery

Also known as: Ropivacaine, Naropin
Sole local anesthetic
Sufentanil (Opioid plus local anesthetic)DRUG

Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery

Also known as: Naropin
Opioid plus local anesthetic
RopivacaineDRUG
Opioid plus local anestheticSole local anesthetic

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Nulliparas
  • Request epidural analgesia
  • Chinese

You may not qualify if:

  • Allergic to opioid or local anesthetics
  • Fail to perform epidural puncture and catheterization
  • Organ dysfunction
  • Contraindications for epidural anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

Location

Related Publications (1)

  • 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.

    PMID: 26512604DERIVED

MeSH Terms

Conditions

Pain

Interventions

RopivacaineSufentanilAnalgesics, OpioidAnesthetics, Local

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesFentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnesthetics

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 11, 2014

First Posted

January 14, 2014

Study Start

September 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 4, 2014

Record last verified: 2014-02

Locations

CN(1)