NCT02565303

Brief Summary

Ropivacaine is one of commonly used anesthetics for spinal anesthesia. Usually L2-3 or L3-4 intervertebral space is chosen for spinal anesthesia. The efficacy of ropivacaine injected into subarachnoid space depends on the given dose and the chosen intervertebral space. Appropriate dose could satisfy the requirement of operation and reduce incidence of the adverse reaction. But it is not certain about the minimum effective dose of ropivacaine in cesarean section through the two intervertebral spaces, respectively. This study is being conducted to find the minimum effective doses for L2-3 and L3-4 spinal anesthesia in cesarean section.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

September 30, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1.7 years

First QC Date

September 19, 2015

Last Update Submit

February 28, 2018

Conditions

Spinal Anesthesia

Keywords

cesarean deliveryropivacaineminimum effective dosedose-response relationshipintrathecalintervertebral space

Outcome Measures

Primary Outcomes (1)

  • sensory block assessment evaluated with visual analogue scale (VAS) and sensory dermatomal anesthesia

    Sensory block assessment will be evaluated with VAS and sensory dermatomal anesthesia. Criteria for evaluation of anesthetic efficacy:(1) effective: within 10 minutes after intrathecal injection, a dose that provides adequate sensory dermatomal anesthesia to pinprick to T6 or higher, and the VAS is lower than or equal to 3 within 60minutes after skin incision; (2) ineffective: the initial plane of sensory dermatomal anesthesia is lower than T6 or VAS is higher than 3 within 60 minutes after skin incision. VAS is a psychometric response scale which can be used in questionnaires. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points, where 0 was no pain and 10 was the worst. A dermatome is an area of skin that is mainly supplied by a single spinal nerve.Usually the upper sensory dermatomal anesthesia is used to assess the effect of intrathecal anesthesia.

    during the entire procedure of operation

Secondary Outcomes (1)

  • motor block accessment

    10minutes after the spinal anesthesia finished

Other Outcomes (2)

  • incidence of adverse reaction

    during the entire procedure of operation

  • effect of abdominal muscle relaxation

    during the entire procedure of operation

Study Arms (2)

L2-3 intervertebral group

EXPERIMENTAL

The initial dose of ropivacaine for subarachnoid is chosen as 12 mg in L2-3 intervertebral space group.

Procedure: Intervertebral spaceDrug: Ropivacaine

L3-4 intervertebral group

EXPERIMENTAL

The initial dose of ropivacaine for subarachnoid is chosen as 15 mg in L3-4 group.

Procedure: Intervertebral spaceDrug: Ropivacaine

Interventions

Intervertebral spacePROCEDURE
L2-3 intervertebral groupL3-4 intervertebral group
RopivacaineDRUG

The initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group with the volume of 3 mL in both groups. The testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group.If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg.

Also known as: Naropin
L2-3 intervertebral groupL3-4 intervertebral group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Full term parturient(\> 37 and \<42 weeks gestation)
  • Above 20 years and below 35 years
  • American Society of Anesthetists(ASA) I to II
  • Singleton pregnancy
  • Elective cesarean section
  • Body weight during 60-85kg, height during 150-170cm

You may not qualify if:

  • Patient refusal
  • Hypertension
  • Diabetes mellitus
  • Heart diseases
  • Asthma
  • Abnormal fetus or placenta
  • Contraindications to combined spinal-epidural anesthesia(CSEA)
  • Allergy to ropivacaine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 021, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physician

Study Record Dates

First Submitted

September 19, 2015

First Posted

October 1, 2015

Study Start

September 30, 2015

Primary Completion

May 31, 2017

Study Completion

June 30, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Locations

CN(1)