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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00150865
Other study ID # CP 02-01
Secondary ID
Status Completed
Phase N/A
First received September 7, 2005
Last updated October 30, 2017
Start date September 2001
Est. completion date March 2002

Study information

Verified date September 2005
Source University Hospital, Angers
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h.

Expectation : sizeable reduction of pain with block, of duration.


Description:

Compare lumbar plexus block (randomized)

- ropivacaine 0.475%, 0.4 ml/kg

- saline 0.4 ml/kg . Each group includes 30 patients.

Block performed preoperatively.

Surgery under general anesthesia (sufentanil, propofol, atracurium ; maintenance : sevoflurane and nitrous oxide in O2. Sufentanil added peroperatively as clinically needed.

Postoperative evaluation of pain (VAS, by an independant blind observer) as first endpoint, and also morphine consumption via PCA device.

Adverse effects (nausea, vomiting, etc) recorded

Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2002
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults

- ASA 1-3

Exclusion Criteria:

- cognitive impairement

- ASA IV

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ropivacaine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Angers

Outcome

Type Measure Description Time frame Safety issue
Primary decrease of postoperative pain
Secondary decrease in morphine consumption
Secondary duraration of analgesic effect
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