NCT02711072

Brief Summary

SPINAL anesthesia is commonly used for cesarean section, and it has become a popular practice to add opioids to spinal solutions to enhance and prolong intraoperative and postoperative analgesia. high incidence of side effects was noted. is there any alternative?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Status
unknown

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

March 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

Same day

First QC Date

March 14, 2016

Last Update Submit

March 14, 2016

Conditions

Regional AnesthesiaCaeserian SectionLocal Anesthetic

Outcome Measures

Primary Outcomes (1)

  • Visual Analogic Scale

    quality of postoperative analgesia

    until 48 hours postoperative

Secondary Outcomes (2)

  • occurrence of complications

    48 hours post operative

  • total dose of morphine consumption in mg

    during 48 hours post operative

Study Arms (2)

control group

PLACEBO COMPARATOR
Drug: control groupDrug: infiltration group

infiltration group

ACTIVE COMPARATOR
Drug: control groupDrug: infiltration group

Interventions

control groupDRUG

spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h

control groupinfiltration group
infiltration groupDRUG

spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.

control groupinfiltration group

Eligibility Criteria

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

You may qualify if:

  • ASA physical status I-II
  • years of age, inclusive
  • elective caeserean section under spinal anesthesia

You may not qualify if:

  • \- contraindications to spinal anesthesia (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
  • existing neurological deficit
  • inability to understand the informed consent and demands of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor, MD

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 17, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03