Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604598
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of NSAID Steroid Therapy for PGE2 Level and Analgesia After Percutaneous Nephrolithotomy Surgery a Double Blinded Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BUPARDEX
Brief Summary:
The goal of this clinical trial is to learn if combination of NSAID-steroid can decrease the PGE2 level and postoperative pain after percutaneous nephrolithotomy surgery It will also learn about the side effects of combination of those drugs The main questions it aims to answer are
Does combination of NSAID steroid can lower the PGE2 level and NRS score after percutaneous nephrolithotomy surgery What side effect do participants have when taking combination of NSAID-steroid after percutaneous nephrolithotomy surgery Researchers will compare Group IBU-PCT-DEX ibuprofen -paracetamol-dexamethasone Group IBU-PCT-placebo ibuprofen-paracetamol-placebo and Group PCT-placebo-placebo paracetamol-placebo-placebo to see the difference level of PGE2 and NRS score after percutaneous nephrolithotomy surgery
Participants will
Receive drug intravenously according to group allocation every 8 hours Report the side effects when taking medication during trial
Does combination of NSAID steroid can lower the PGE2 level and NRS score after percutaneous nephrolithotomy surgery What side effect do participants have when taking combination of NSAID-steroid after percutaneous nephrolithotomy surgery Researchers will compare Group IBU-PCT-DEX ibuprofen -paracetamol-dexamethasone Group IBU-PCT-placebo ibuprofen-paracetamol-placebo and Group PCT-placebo-placebo paracetamol-placebo-placebo to see the difference level of PGE2 and NRS score after percutaneous nephrolithotomy surgery
Participants will
Receive drug intravenously according to group allocation every 8 hours Report the side effects when taking medication during trial
Detailed Description:
Our study aim to investigate the effect of NSAID steroid therapy to PGE2 level and analgesia after percutaneous nephrolithotomy surgery This study is a double blind randomized controlled trial at a primary health care center in Purwokerto Indonesia This trial involved 45 patient who underwent elective percutaneous nephrolithotomy surgery who met the inclusion and exclusion criteria Patient was randomized and divided into three groups Each group consisted of 15 patients Ibuprofen 2x400 mg iv paracetamol 2x1 gr iv dexamethasone 2x5 mg iv will be given within the IBU-PCT-DEX intervention Ibuprofen 2x400 mg iv paracetamol 2x1gr iv 2xplacebo normal saline alike dexamethasone iv will be given within the IBU-PCT-placebo intervention Paracetamol 2x1 gr iv 2xplacebo normal saline alike ibuprofen 2xplacebo normal saline alike dexamethasone will be given within the PCT-placebo-placebo intervention The analgesics were given during surgery and 8 hours after first drug administration Plasma level of PGE2 will be measured with ELISA and analgesia will be measured using numeric rating scale NRS an hour after two times drug administration Primary outcome was PGE2 level and NRS score after percutaneous nephrolithotomy among three group of comparison Secondary outcome was the side effect of analgesic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None