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Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
Fayoum University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring cardiac surgery, fast track anesthesia, postoperative analgesia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 20 - 65 years, Ejection fraction (EF) > 35%, Elective-isolated CABG, or Valve surgery Exclusion Criteria: Poor left ventricular function with intra-aortic balloon pump support, Recent myocardial infarction (last seven days), Combined procedure (i.e., CABG + other heart/vascular procedure), Emergency surgery, or Redo cases, Hepatic or renal failure, creatinine >1.5, Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.

Sites / Locations

  • King Saud UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Group (C)

Group (R)

Group (DR)

Arm Description

will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.

will receive 30 ml of 0.25% of plain ropivacaine for each side.

will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.

Outcomes

Primary Outcome Measures

the total postoperative opioid consumption
the total postoperative opioid consumption

Secondary Outcome Measures

Duration of mechanical ventilation
Duration of mechanical ventilation (day)

Full Information

First Posted
May 23, 2023
Last Updated
September 11, 2023
Sponsor
Fayoum University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05897307
Brief Title
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block
Official Title
Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
August 10, 2024 (Anticipated)
Study Completion Date
August 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fayoum University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Multimodal analgesia for control of postoperative pain in cardiac surgical patients helps in early recovery and ambulation. Pectoral nerve (PECS) block with ropivacaine is novel, less invasive regional analgesic technique with an effect comparable to paravertebral, and thoracic epidural analgesia. Aim: The aim of this study is to assess the effect of dexmedetomidine as an adjuvant to ropivacaine on the quality and efficiency of the ultra-sound guided pectoralis nerve block in patients undergoing open heart surgery through midline sternotomy for fast-track anesthesia and postoperative analgesia.
Detailed Description
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 chest wall such as radical mastectomies, breast-conserving surgeries, breast implant placement, automated implantable cardioverter-defibrillator (AICD)/pacemaker placement, intercostal drainage tube placement, and rib fractures. [1] PECS I & II blocks are considered very safe due to the lack of major neurovascular bundles surrounding the area of interest [2, 3]. In 2018 Kumar et al. [4] investigated the efficacy of ultrasound-guided bilateral PECS block for patients undergoing cardiac surgery through midline sternotomy approach. They concluded that Pecs block is technically simple, safe, and very effective technique and can be used as a part of multimodal analgesia in postoperative cardiac surgical patients for better patient comfort and satisfaction and also helps in superior pulmonary rehabilitation, thus assisting in better outcome. [4] With ultrasound guidance, this block has a short learning curve, and because it is superficial block, it is easier to apply, and this is one of the reasons for its increasing use and importance, and it is often performed instead of thoracic epidural block (TEA) and thoracic paravertebral block (TPVB). [4] The current data clearly demonstrates earlier extubation and reduced perioperative narcotic consumption [4-6], which are inherently beneficial for the patient. Adequate pain control is critical for respiratory mechanics and metabolic activity, especially for cardiac patients. Compared with other regional anesthesia techniques, the ability to perform PECS block in the supine position is a critical advantage as it is convenient to place and should not impact the logistics of the operating room workflow. In addition, it has great potential as a postop analgesic option for cardiac surgeries, possibly as a rescue block. [4] Ropivacaine is a long-acting local anaesthetic agent that is less lipophilic than bupivacaine, and this reduced lipophilicity is associated with decreased potential for central nervous system toxicity and cardiotoxicity. [7] Dexmedetomidine is a potent and highly selective α2-adrenoreceptor agonist. It has sedative-hypnotic, anxiolytic, analgesic, anesthetic-reducing and local anesthetic effects. [8] The mechanism of action of dexmedetomidine for potentiation of local anesthetics may be through its central action, α-2 receptor-mediated vasoconstriction, attenuation of inflammatory responses, direct effect on peripheral nerves, or by increasing the activity-dependent hyperpolarization through blocking the hyperpolarization-activated cation (Ih) current. [9] The available preclinical and clinical data propose that the addition of dexmedetomidine with local anesthetics is well tolerated without signs of neurotoxicity. [10] In this study, we hypothesized that adding dexmedetomidine as an adjuvant to ropivacaine can result in prolongation of 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. Patients and Methods: After approval of our local ethical committee, and based upon written informed consent, ninety patients, ASA physical statuses III or IV, undergoing either coronary artery bypass grafting (CABG) or valve surgeries through midline sternotomy will be enrolled in the study. Inclusion criteria: Age 20 - 65 years, Ejection fraction (EF) > 35%, Elective isolated CABG, or Valve surgery Exclusion criteria: Poor left ventricular function with intra-aortic balloon pump support, Recent myocardial infarction (last seven days), Combined procedure (i.e., CABG + other heart/vascular procedure), Emergency surgery, or Redo cases, Hepatic or renal failure, creatinine >1.5, Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
cardiac surgery, fast track anesthesia, postoperative analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group (C)
Arm Type
Placebo Comparator
Arm Description
will not receive any regional anesthesia and only will receive fentanyl 1μg/kg/hr.
Arm Title
Group (R)
Arm Type
Active Comparator
Arm Description
will receive 30 ml of 0.25% of plain ropivacaine for each side.
Arm Title
Group (DR)
Arm Type
Active Comparator
Arm Description
will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg for each side.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
dexmedetomidine
Primary Outcome Measure Information:
Title
the total postoperative opioid consumption
Description
the total postoperative opioid consumption
Time Frame
the first 48 hours postoperative
Secondary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation (day)
Time Frame
the first 48 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20 - 65 years, Ejection fraction (EF) > 35%, Elective-isolated CABG, or Valve surgery Exclusion Criteria: Poor left ventricular function with intra-aortic balloon pump support, Recent myocardial infarction (last seven days), Combined procedure (i.e., CABG + other heart/vascular procedure), Emergency surgery, or Redo cases, Hepatic or renal failure, creatinine >1.5, Patients with hemodynamic instability, preexisting infection at the site of block, allergy to local anesthetics, psychiatric illness, and patients with prolonged postoperative ventilatory course were excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed Hamed, MD
Phone
01010509736
Ext
002
Email
mah07@fayoum.edu.eg
Facility Information:
Facility Name
King Saud University
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mostafa mohammed Elhamamsy, MD
Phone
+966568799134
Ext
+966
Email
mostafah333@gmail.com
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Aldemerdash, MD
Phone
+966567243333
Ext
+966
Email
drdemerdash@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plane
Citations:
PubMed Identifier
22939099
Citation
Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.
Results Reference
background
PubMed Identifier
28802149
Citation
Ueshima H, Otake H. RETRACTED: Ultrasound-guided pectoral nerves (PECS) block: Complications observed in 498 consecutive cases. J Clin Anesth. 2017 Nov;42:46. doi: 10.1016/j.jclinane.2017.08.006. Epub 2017 Aug 9. No abstract available.
Results Reference
background

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Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve Block

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