Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-28 @ 1:22 AM
Study NCT ID:
NCT04050059
Status:
COMPLETED
Last Update Posted:
2020-04-08
First Post:
2019-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
Comparison of Two Analgesic Pretreatment Techniques (2% Lidocaine Infiltration vs. EMLA Cream Application) Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS. A Prospective Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.
Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.
EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.
We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.
Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.
EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.
We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.
Detailed Description:
OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.
Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine
Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: