An interventional study of Levobupivacaine Solution and Ropivacaine Solution in Pain, Postoperative, sponsored by Alexandr Ronenson. Status unknown at 1 site in Russian Federation. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Alexandr Ronenson · Not applicable, Interventional, and Treatment
Among 20 studies testing levobupivacaine in Pain, Postoperative — 1 open to participants now, 1 under way, none of them phase 3. Levobupivacaine · Pain, Postoperative.
Among the 20 studies testing levobupivacaine in Pain, Postoperative, this one is the 11th largest by enrollment, is the only one that started in 2017, is one of 8 with no phase, and was the 12th registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 50 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →1 of the 20 studies testing levobupivacaine in Pain, Postoperative is open now, in 1 country. Each count lists the studies.
Levobupivacaine: first FDA approval 1999 (CHIROCAINE). What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
Median enrollment 51 across the 20 interventional studies. Of the 13 that completed or were terminated, 1 (8%) have results posted.
None of the 20 has an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Alexandr Ronenson as lead sponsor.
Alexandr Ronenson has 1 study filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing levobupivacaine in Pain, Postoperative, from their registry updates:
Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block
Objectives:
For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897, 2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer: Fresenius Kabi Norge (Norway).
Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.
It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on each side was injected.
The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the VAS.
All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)
Additionally:
Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM with VAS = or > 5 score, lockout time 6 hours
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
TAP-block with Ropivacaine Solution
Drug: Ropivacaine Solution
TAP-block with Levobupivacaine Solution
Drug: Levobupivacaine Solution
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
Also known as: Levo
TAP-block with Ropivacaine 0,3% - 25 ml from each side
Also known as: Rop
Level of pain
Measurement of pain on a VAS scale (from 0 to 10 points)
Time frame: 12 hours
The need for additional analgesics (Paracetamol, Tramadol)
Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores
Time frame: 12 hours
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Levobupivacaine · Ropivacaine