Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-30 @ 12:41 PM
Study NCT ID:
NCT04981951
Status:
UNKNOWN
Last Update Posted:
2023-07-20
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Th Effects of a Drug Dexmedotemidine in Regional Anesthesia in Participants Undergoing Upper Limb Surgeries
Sponsor:
Zaher Nazzal
Organization:
Study Overview
Official Title:
Dexmedetomidine as an Adjuvant to Local Anesthesia in Supraclavicular Plexus Block, A Randomized Control Trial.
Status:
UNKNOWN
Status Verified Date:
2023-07
Last Known Status:
RECRUITING
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:
In this study, we will assess the effect of combined Dexmedetomidine and Bupivacaine analgesia on the onset and duration of anesthesia in supraclavicular plexus block compared to Bupivacaine alone.
Detailed Description:
Participants who fulfill the inclusion criteria will be enrolled in this study to achieve sample size of 140 participants, 70 participants in each group.
Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).
On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.
Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.
Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.
Participants were blindly randomized into two groups: group A (Bupivacaine alone) and group B (Bupivacaine with Dexmedetomidine).
On the morning of the surgery day, and before performing the procedure on the targeted hand, a venous cannula 18gauze was secured on the opposite hand. Routine monitors like pulse oximetry, non-invasive blood pressure, and electrocardiogram were attached during the procedure.
Study medications were prepared for each group, which is Bupivacaine (30ml) only for group A and Bupivacaine (30 ml) with Dexmedetomidine (1 mcg /kg) for group B. Then, SCPB was done under ultrasound guidance which increases the safety due to improved monitoring of anatomy and needle placement. A needle was placed within the brachial plexus sheath posterior to the subclavian artery, and the local anesthetic injected to surround the trunks and divisions of the brachial plexus at this level.
Patients were evaluated for the onset of the sensory and motor block every 3 minutes after completion of injection till their onset, and, at 15, 30, 45, 60, 90, and 120 min; and then hourly (even after surgery), until they had resolved.
Study Oversight
Has Oversight DMC:
False
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?: