Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT06917820
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clavipectoral Block Versus Interscalene Block for Postoperative Analgesia in Midshaft Clavicular Surgery
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Ultrasound-guided Clavipectoral Fascia Plane Block Versus Interscalene Brachial Plexus Block for Postoperative Analgesia in Midshaft Clavicular Surgery
Status:
RECRUITING
Status Verified Date:
2025-01
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 aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries.
Detailed Description:
The aim of this study is to compare between (ISBPB) and (CPB) as postoperative analgesic technique following midshaft clavicular fracture open reduction and internal fixation surgeries. Preoperative full precise medical history will be taken from patients. Routine investigations will be done to all patients including ECG and laboratory investigations as CBC, AST, ALT, INR, PT and PTT. Demographic data as age and weight will be recorded. All patients will be consented for every anesthetic and surgical procedure to be done. For all patients, on arrival to the operating room, ECG, heart rate (HR), non-invasive blood pressure, and pulse oximetry will be monitored. Patients will receive 0.03 mg/kg of IV midazolam as anxiolytic and 3 L/ min nasal oxygen.
Then, in supine position, the diaphragmatic excursion measurement will be performed on the hemidiaphragm at the same side of the study block. Excursion amplitude will be defined as the craniocaudal perpendicular distance from the minimum to the maximum point of diaphragm excursion. Diaphragmatic excursion measurements will be performed before induction of general anesthesia and performing the block technique and at 3 hours after the block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours.
After that, induction of GA will be performed by injecting intravenous (IV) 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.5 mg/kg atracurium.
Then, the patients will receive one of the study blocks as following:
Group A: This group will receive ultrasound-guided clavipectoral fascia plane block.
Group B: This group will receive ultrasound-guided interscalene plexus block.
Then, in supine position, the diaphragmatic excursion measurement will be performed on the hemidiaphragm at the same side of the study block. Excursion amplitude will be defined as the craniocaudal perpendicular distance from the minimum to the maximum point of diaphragm excursion. Diaphragmatic excursion measurements will be performed before induction of general anesthesia and performing the block technique and at 3 hours after the block or 1 hour after recovery from anesthesia if the surgery lasted more than 2 hours.
After that, induction of GA will be performed by injecting intravenous (IV) 1 mcg/kg fentanyl, 2 mg/kg propofol and 0.5 mg/kg atracurium.
Then, the patients will receive one of the study blocks as following:
Group A: This group will receive ultrasound-guided clavipectoral fascia plane block.
Group B: This group will receive ultrasound-guided interscalene plexus block.
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?:
False
Is an FDA AA801 Violation?: