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RecruitingNCT06636578Updated Oct 15, 2024

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

A Phase 4 interventional study of dexmedetomidine and ropivacaine in Analgesia, sponsored by Fayoum University. Recruiting at 2 sites in Egypt. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Fayoum University · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2024; still recruiting 1 year 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study 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.

Read the 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 mg/kg). 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 1μg/kg/hr.

For the other two groups, regional anesthesia will be used, and every patient in these two groups will receive 20 ml of ropivacaine 0.25% 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 0.25% of plain ropivacaine for each side.

Group (DR) (n = 30): will receive 30 ml of 0.25% of ropivacaine + dexmedetomidine 0.5 μg/kg 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. Patient's satisfaction level will be assessed with a Likert five-item scoring system
02

Conditions studied

  • Analgesia

Keywords

  • PECS block
  • analgesia after median sternotomy
03

In context

Lead sponsor

Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    Group (DR)

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

    Drug: dexmedetomidine · Drug: ropivacaine

  • Active comparator
    Group (R)

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

    Drug: ropivacaine

  • Sham comparator
    Group (C)

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

    Drug: fentanyl

Interventions

  • Drugdexmedetomidine

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

    Also known as: precedex

  • Drugropivacaine

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

    Also known as: plain ropivacaine

  • Drugfentanyl

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: The first 24 hours postoperative

  2. 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

    Time frame: from the time of ICU admission hour 1 up to hour 24

07

Study locations

1 of 2 sites recruiting
  • Fayoum University Hospital
    Fayoum, 63511, Egypt
    Completed
  • Mohamed Hamed
    Fayoum, 63511, Egypt
    • mohadme a hamed, MD · Contact · dhamed81@yahoo.com · 01118560065
    • mohamed a hamed, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36647492 ↗
  • 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. PubMed 30052231 ↗
  • 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. PubMed 29016551 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06636578
Lead sponsor
Fayoum University
Responsible party
Mohamed Ahmed Hamed (Associate Professor, Fayoum University) — Principal investigator
First posted
Oct 10, 2024
Start date
Oct 10, 2024
Primary completion
Dec 31, 2024 (estimated)
Completion
Jan 8, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

mina fam, M.D
Contact
mms12@fayoum.edu.eg
01025273637
Mostafa Elhamamsy, M.D
Contact
mostafah333@gmail.com
+966 56 879 9134
mohamed hamed, M.D
principal investigator · Fayoum University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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