Condition category
Pregnancy and Childbirth
Date applied
23/07/2011
Date assigned
09/12/2011
Last edited
31/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Zhen Zeng

ORCID ID

Contact details

No. 600 Yishan Road
Shanghai
200233
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Dilution of ropivacaine by saline can decrease its dose requirement in spinal anesthesia for cesarean section: a randomized blinded controlled trial

Acronym

Study hypothesis

There are difference in terms of effect of ropivacaine between dilution by saline and cerebrospinal fluid in spinal anesthesia

Ethics approval

Ethical Review Committee of the Sixth People's Hospital affiliated to Shanghai Jiaotong University approved on 12 June 2010, ref: 20100323

Study design

Randomized blinded controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Elective cesarean delivery

Intervention

The patients were randomly allocated to 2 groups to receive combined spinal epidural anesthesia for cesarean section.

Group RS received intrathecal isobaric 1% ropivacaine (Naropin, AstraZeneca, China) diluted to 5 mg/ml by saline.

Group RC received intrathecal isobaric 1% ropivacaine (Naropin, AstraZeneca, China) diluted to 5 mg/ml by cerebrospinal fluid (CSF). Using Dixon up-down sequential allocation technique, the amount of local anesthetic drug received by a particular parturient was determined by the response of the previous parturient in the respective group. Based on previous clinical experience, the first parturient in each group received 20mg ropivacaine.The inadequate anesthesia cases in each group were managed by epidural volume extension. Patients were given 10ml 1% Lidocaine through the epidural catheter into epidural space.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ropivacaine

Primary outcome measures

1. Effective Dose 50 (ED50) of ropivacaine for intrathecal administration
2. The rate of adequate anesthesia

Secondary outcome measures

1. Heart rate
2. Systolic, diastolic, and mean arterial blood pressure
3. Hemoglobin oxygen saturation

Overall trial start date

31/07/2011

Overall trial end date

01/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. American Society of Anesthesiologists (ASA) physical status I to II
2. Undergoing elective cesarean delivery
3. No contraindications to subarachnoid anesthesia

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant exclusion criteria

1. Allergic to local anesthetics
2. Emergent cesarean deliveries
3. Body mass index (BMI) < 22 or >30
4. Hypertensive disorders
5. Peripartum hemorrhagic conditions
6. Neurologic, cardiac or hematologic diseases
7. Diabetes
8. Eclampsia
9. Fetal distress, or known fetal anomalies

Recruitment start date

31/07/2011

Recruitment end date

01/10/2011

Locations

Countries of recruitment

China

Trial participating centre

No. 600 Yishan Road
Shanghai
200233
China

Sponsor information

Organisation

6th Affiliated Hospital to Shanghai Jiaotong University (China)

Sponsor details

Department of Anesthesiology
Shanghai
200233
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

th Affiliated Hospital to Shanghai Jiaotong University (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes