Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2026-01-03 @ 9:15 PM
Study NCT ID:
NCT05141461
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2021-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery
Sponsor:
Karaman Training and Research Hospital
Organization:
Study Overview
Official Title:
The Effect of Intravenous Dexamethasone on Rebound Pain After Interscalene Brachial Plexus Block for Shoulder Surgery: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-10
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:
The rebound pain after nerve block could interfere with the patient's recovery and rehabilitation. It is not known how intravenous dexamethasone affects rebound pain. This study aims to evaluate the effect of intravenous dexamethasone on rebound pain after interscalene block for shoulder surgery.
Detailed Description:
Shoulder rotator cuff repair and acromioplasty are associated with severe postoperative pain. The interscalene block (ISB) is commonly used for this type of surgery, providing analgesia by anesthetizing the nerves that supply the shoulder. Although the nerve block provides extremely effective analgesia for the first 6-8 hours, patients experience severe pain once its effect has been wearing off. Rebound pain is a severe pain that occurs when the effect of a nerve block disappears in a patient during the postoperative period. The purpose of this study is to investigate whether the use of intravenous dexamethasone reduces rebound pain in patients recruiting for shoulder surgery with interscalene brachial plexus blockade.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective shoulder surgery will be screened for enrollment in the study. All subjects will undergo ultrasound-guided interscalene nerve block before induction of general anesthesia. They will be randomly assigned into the two groups which use intravenous dexamethasone or not. An anesthesiologist who will perform blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative pain scores, nausea and vomiting, opioid consumption, quality of Sleep, and Quality of Recovery score will be blinded to the group assignment.
Study Oversight
Has Oversight DMC:
None
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?: