Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636578
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve PECS Block
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve PECS Block for Fast Tracking and Postoperative Analgesia in Open Heart Surgery Through Midline Sternotomy A Randomized Clinical Trial
Status:
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:
None
Brief Summary:
In 2012 Blanco et al 1 described the ultrasound technique for Pectoral nerve PECS block as a new less invasive regional analgesic technique for breast surgeries
PECS block includes PECS I and PECS II modified PECS I interfascial blocks Since that time PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies breast-conserving surgeries breast implant placement automated implantable cardioverter-defibrillator AICDpacemaker placement intercostal drainage tube placement and rib fractures In this study the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine
PECS block includes PECS I and PECS II modified PECS I interfascial blocks Since that time PECS block has been used successfully with good results for a wide variety of surgeries on the chest wall such as radical mastectomies breast-conserving surgeries breast implant placement automated implantable cardioverter-defibrillator AICDpacemaker placement intercostal drainage tube placement and rib fractures In this study the investigators hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in the prolongation of the duration of anesthesia with improvement of the quality of postoperative analgesia of bilateral PECS block for patients undergoing cardiac surgery via midline sternotomy compared with using only plain ropivacaine
Detailed Description:
This study will be performed at the FAYOUM University Hospital after approval from the local Institutional Ethics Committee and the local Institutional Review Board It will be a double-blind randomized controlled study The eligible patients will sign a detailed informed consent form before recruitment and randomization
After confirming hemodynamic stability satisfactory blood gasses electrolytes normalized activated coagulation time ACT 120 s and minimal drain output bilateral PECS block will be performed guided by a linear ultrasound transducer 12 MHz 5
The block will be performed in a supine position with the arm slightly abducted Under complete aseptic precautions and using a 20 gauge 5 cm needle The ultrasound probe will be placed at the midclavicular level inferolaterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major pectoralis minor and serratus anterior muscles were identified at the level of the fourth rib
The needle will be inserted in the plane concerning the ultrasound probe A volume of 20 ml of local anesthetic solution will be deposited in the fascial plane between pectoralis minor and serratus anterior muscle followed by withdrawal of the needle to the fascial plane between pectoralis major and pectoralis minor muscle where a volume of 10 ml will be deposited The block will be performed similarly on both sides It will be noted that the total dose of local anesthetic is not to exceed the toxic dose of ropivacaine 3 mgkg Patients then will be transferred intubated to the Surgical ICU SICU and standard monitoring will be continued until patients are fully awake patients will be extubated once they fulfilled the extubation criteria
Sample Size number of participants included 90 patients
Methodology in detail
All patients will receive a slandered anesthesia technique The main goal of the anesthesia technique will be to ensure a rapid return of consciousness and protective reflexes with minimal residual sedative effects and importantly it should facilitate early ambulation Continuous infusion of fentanyl midazolam and rocuronium as total intravenous anesthesia TIVA
At the end of the surgery TIVA will be stopped and paracetamol 1 gm IV infusion over 15 min will be administered with closure of the sternum
After dressing Patients will be randomly allocated into three groups
Group C control group n 30 will not receive any regional anesthesia and only will receive fentanyl 1μgkghr
For the other two groups regional anesthesia will be used and every patient in these two groups will receive 20 ml of ropivacaine 025 will be used by the surgeon for infiltration in the surgical incision site and in the skin around the mediastinal drains In addition every patient in these two groups will receive bilateral ultrasound-guided PECS block as follows
Group R n 30 will receive 30 ml of 025 of plain ropivacaine for each side
Group DR n 30 will receive 30 ml of 025 of ropivacaine dexmedetomidine 05 μgkg for each side
Measured data
1 pain assessment will be done using the VAS scoring system On a pain scale 0-10 at rest and during cough by an intensivist blinded to the study groups at 0 h at extubation and thereafter at 3 6 12 18 and 24 h intervals Pain will be classified into mild moderate and severe for analysis mild VAS 0-4 moderate VAS 5-7 and severe VAS 8
2 Duration of mechanical ventilation
3 total dose of fentanyl used for breakthrough pain
4 incidence of any complications
5 duration of ICU stay
6 Patients satisfaction level will be assessed with a Likert five-item scoring system
After confirming hemodynamic stability satisfactory blood gasses electrolytes normalized activated coagulation time ACT 120 s and minimal drain output bilateral PECS block will be performed guided by a linear ultrasound transducer 12 MHz 5
The block will be performed in a supine position with the arm slightly abducted Under complete aseptic precautions and using a 20 gauge 5 cm needle The ultrasound probe will be placed at the midclavicular level inferolaterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major pectoralis minor and serratus anterior muscles were identified at the level of the fourth rib
The needle will be inserted in the plane concerning the ultrasound probe A volume of 20 ml of local anesthetic solution will be deposited in the fascial plane between pectoralis minor and serratus anterior muscle followed by withdrawal of the needle to the fascial plane between pectoralis major and pectoralis minor muscle where a volume of 10 ml will be deposited The block will be performed similarly on both sides It will be noted that the total dose of local anesthetic is not to exceed the toxic dose of ropivacaine 3 mgkg Patients then will be transferred intubated to the Surgical ICU SICU and standard monitoring will be continued until patients are fully awake patients will be extubated once they fulfilled the extubation criteria
Sample Size number of participants included 90 patients
Methodology in detail
All patients will receive a slandered anesthesia technique The main goal of the anesthesia technique will be to ensure a rapid return of consciousness and protective reflexes with minimal residual sedative effects and importantly it should facilitate early ambulation Continuous infusion of fentanyl midazolam and rocuronium as total intravenous anesthesia TIVA
At the end of the surgery TIVA will be stopped and paracetamol 1 gm IV infusion over 15 min will be administered with closure of the sternum
After dressing Patients will be randomly allocated into three groups
Group C control group n 30 will not receive any regional anesthesia and only will receive fentanyl 1μgkghr
For the other two groups regional anesthesia will be used and every patient in these two groups will receive 20 ml of ropivacaine 025 will be used by the surgeon for infiltration in the surgical incision site and in the skin around the mediastinal drains In addition every patient in these two groups will receive bilateral ultrasound-guided PECS block as follows
Group R n 30 will receive 30 ml of 025 of plain ropivacaine for each side
Group DR n 30 will receive 30 ml of 025 of ropivacaine dexmedetomidine 05 μgkg for each side
Measured data
1 pain assessment will be done using the VAS scoring system On a pain scale 0-10 at rest and during cough by an intensivist blinded to the study groups at 0 h at extubation and thereafter at 3 6 12 18 and 24 h intervals Pain will be classified into mild moderate and severe for analysis mild VAS 0-4 moderate VAS 5-7 and severe VAS 8
2 Duration of mechanical ventilation
3 total dose of fentanyl used for breakthrough pain
4 incidence of any complications
5 duration of ICU stay
6 Patients satisfaction level will be assessed with a Likert five-item scoring system
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