Dexmedetomidine Ropivacaine Versus Plain Ropivacaine in Bilateral Pectoralis Nerve (PECS) Block

NCT06636578 | Recruiting Phase 4

• 1 other identifier: R 611
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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 (AICD)/pacemaker 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.

Conditions

Analgesia

Keywords

PECS block; analgesia after median sternotomy

Outcome Measures

Primary Outcomes (2)

• pain assessment will be done using VAS scoring system

  (In 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)

  The first 24 hours postoperative

• Total opioid consumption

  the amount of opioid (mostly used is fentanyl amp. in equivalent doses ) that has been used for 24 hours after admission in ICU

  from the time of ICU admission hour 1 up to hour 24

Study Arms (3)

Group (DR)

ACTIVE COMPARATOR

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

Drug: dexmedetomidine; Drug: ropivacaine

Group (R)

ACTIVE COMPARATOR

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

Drug: ropivacaine

Group (C)

SHAM COMPARATOR

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

Drug: fentanyl

Interventions

dexmedetomidine DRUG

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

Also known as: precedex

Group (DR)

ropivacaine DRUG

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

Also known as: plain ropivacaine

Group (DR); Group (R)

fentanyl DRUG

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

Group (C)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 - 65 years,
• Ejection fraction (EF) \> 35%,
• Elective isolated CABG, or Valve surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (2)

Fayoum University Hospital

Al Fayyum, 63511, Egypt

COMPLETED

Mohamed Hamed

Al Fayyum, 63511, Egypt

RECRUITING

Related Publications (3)

• Sertcakacilar G, Tire Y, Kelava M, Nair HK, Lawin-O'Brien ROC, Turan A, Ruetzler K. Regional anesthesia for thoracic surgery: a narrative review of indications and clinical considerations. J Thorac Dis. 2022 Dec;14(12):5012-5028. doi: 10.21037/jtd-22-599.

  PMID: 36647492 BACKGROUND

• Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):333-338. doi: 10.4103/aca.ACA_15_18.

  PMID: 30052231 BACKGROUND

• Yalamuri S, Klinger RY, Bullock WM, Glower DD, Bottiger BA, Gadsden JC. Pectoral Fascial (PECS) I and II Blocks as Rescue Analgesia in a Patient Undergoing Minimally Invasive Cardiac Surgery. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):764-766. doi: 10.1097/AAP.0000000000000661.

  PMID: 29016551 BACKGROUND

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Ropivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines

Study Officials

• mohamed hamed, M.D

  Fayoum University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mina fam, M.D

CONTACT

01025273637; mms12@fayoum.edu.eg

Mostafa Elhamamsy, M.D

CONTACT

+966 56 879 9134; mostafah333@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 8, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)